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 . 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 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.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Claim Objections
Claims 2, 3, 9, 10, and 17-20 are objected to because of the following informalities:
Regarding claim 2, the recitation of “being place” should instead read –placed--.
Regarding claim 3, the recitation of “selective” should instead read –selectively--.
Regarding claim 9, the recitation of “detecting” should instead read –is configured to detect--.
Regarding claim 10, the recitation of “creating” should instead read –is configured to create--.
Regarding claim 17, the recitation of “data of” should instead read –data being of--.
Regarding claims 18 and 19, the recitations of “wherein” should instead read –further comprising--.
Regarding claim 20, the recitation of “foot supporting” should instead read –foot-supporting—for consistency.
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”) 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 (e.g. “camera means” includes sufficient structure for the function). 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “illumination source” in claims 1, 5, 12, and 16, “wireless transmission module” in claim 3 and “power source” in claims 5 and 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “illumination source,” an LED bar as in ¶ 0031 of the specification as filed; “wireless transmission module,” a transmitter as in ¶ 0036; and for “power source,” a battery also as in ¶ 0036).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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 pre-AIA the applicant regards as the invention.
Regarding claims 1-3, 5, 7-10, and 20, the recitations of “detecting,” “generating,” “providing,” “transmitting,” “powering,” “imaging,” “obtaining,” “creating,” “scanning,” etc. make it unclear whether an apparatus or method is intended. If an apparatus, the components should be “configured to” perform a function, not actually performing the function.
Regarding claim 12, the recitation of “a diagnostic pane” in line 6 makes it unclear whether this is the same as or different than the diagnostic pane already recited in line 2. For purposes of examination, it will be interpreted as the same.
Claims 2-11 and 13-19 are rejected because they depend on rejected claims.
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.
Claims 1-3, 5-10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0125195 (“Hielscher”) in view of US Patent 7,497,037 (“Vick”) and US Patent Application Publication 2020/0193580 (“McCall”).
Regarding claim 1, Hielscher teaches [a] diabetic foot examination device (¶¶s 0069, 0070, etc.), comprising: a body having a base and an upper structure (Fig. 7G, the base of the overall device, just above the wheels; Fig. 7G, the structure/walls defining chamber 130), the base including a generally horizontal support configured to rest on a generally planar surface (Fig. 7G, the bottom of the device is a horizontal support, configured to rest, via the wheels, on the floor (a generally planar surface)); a diagnostic pane located on the upper structure of the body, the diagnostic pane held at an angled relation to the base (Fig. 7G, platform 132, angled as shown), the diagnostic pane at least partially transparent to visible light and configured to support at least one foot placed thereupon (¶ 0143, the light passing through window 150 of platform 132 – also see Figs. 7A-7C, supporting a foot, and ¶¶s 0135, 0077, etc., red light); at least one camera affixed to the body and detecting illumination in the electromagnetic spectrum (Fig. 7G, camera 160), the camera positioned to view a foot placed against the diagnostic pane and generating diagnostic data from the detected illumination (Figs. 7A-7C, 11, etc.); at least one illumination source affixed to the body, the illumination source providing, at least, illumination in the electromagnetic spectrum directed at the diagnostic pane (Fig. 7G, light source 140, directed at platform 132 as represented by beam 142); and a computer platform in communication with the camera and illumination source (Fig. 7G, ¶ 0144, console 120 housing the optical components and all associated processors), the computer platform selectively configured to (note that although the following is not limiting since the configuration is selective, for purposes of facilitating compact prosecution, it has been found): …; receive diagnostic data from the camera (Fig. 11); … .
Hielscher does not appear to explicitly teach the computer platform configured to: control the illumination source to selectively direct illumination at the diagnostic pane when at least one foot is placed thereagainst (although ¶ 0145 does teach steering the light to a desired position).
Vick teaches turning on a light when the presence of a foot is detected (col. 2, lines 15-31).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively turn on the illumination of Hielscher when the presence of a foot was detected, as in Vick, for the purpose of conversing power (Vick: col. 1, lines 37-43).
Hielscher-Vick does not appear to explicitly teach the computer platform configured to: detect a presence of diabetic ulcers in the at least one foot based upon the received diagnostic data to create a diabetic ulcer diagnostic data (although Hielscher: ¶ 0074 describes identifying the origin of ulcerations, and ¶ 0133 describes diagnosing PAD).
McCall teaches detecting/diagnosing foot ulcers by imaging the foot (¶ 0057).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the imaging already contemplated to diagnose/detect foot ulcers, as in McCall, for the purpose of being able to diagnose an additional condition (and even its severity – McCall: ¶ 0057).
Regarding claim 20, Hielscher teaches [a] diabetic foot examination device (¶¶s 0069, 0070, etc.), comprising: a body means having a base and an upper structure (Fig. 7G, the base of the overall device, just above the wheels; Fig. 7G, the structure/walls defining chamber 130), the base including a generally horizontal support configured to rest on a generally planar surface (Fig. 7G, the bottom of the device is a horizontal support, configured to rest, via the wheels, on the floor (a generally planar surface)); a foot-supporting means for supporting a foot held thereagainst, the foot-supporting means located on the upper structure of the body, the foot supporting means held at an angled relation to the base (Fig. 7G, platform 132, angled as shown), the foot-supporting means at least partially transparent to visible light (¶ 0143, the light passing through window 150 of platform 132 – also see Figs. 7A-7C, supporting a foot, and ¶¶s 0135, 0077, etc., red light); at least one camera means for detecting illumination in the electromagnetic spectrum (Fig. 7G, camera 160), the camera means affixed to the body and positioned to view a foot placed against the foot-supporting means and generating diagnostic data from the detected illumination (Figs. 7A-7C, 11, etc.); at least one illumination means, providing illumination in the electromagnetic spectrum directed at the foot-supporting means, the illumination means affixed to the body (Fig. 7G, light source 140, directed at platform 132 as represented by beam 142); and a diagnostic means (Fig. 7G, ¶ 0144, console 120 housing the optical components and all associated processors) for creating diagnostic data by: …; receiving diagnostic data from the camera means (Fig. 11); … .
Hielscher does not appear to explicitly teach creating diagnostic data by controlling the illumination means to selectively direct illumination at the foot-supporting means when at least one foot is placed thereagainst (although ¶ 0145 does teach steering the light to a desired position).
Vick teaches turning on a light when the presence of a foot is detected (col. 2, lines 15-31).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively turn on the illumination of Hielscher when the presence of a foot was detected, as in Vick, for the purpose of conversing power (Vick: col. 1, lines 37-43).
Hielscher-Vick does not appear to explicitly teach creating diagnostic data by detecting a presence of diabetic ulcers in the at least one foot based upon the received diagnostic data to create a diabetic ulcer diagnostic data (although Hielscher: ¶ 0074 describes identifying the origin of ulcerations, and ¶ 0133 describes diagnosing PAD).
McCall teaches detecting/diagnosing foot ulcers by imaging the foot (¶ 0057).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the imaging already contemplated to diagnose/detect foot ulcers, as in McCall, for the purpose of being able to diagnose an additional condition (and even its severity – McCall: ¶ 0057).
Regarding claim 2, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall further teaches at least one sensor connected to the computer platform, the at least one sensor detecting at least one foot being placed on the diagnostic pane (Vick: col. 2, lines 15-31).
Regarding claim 3, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall further teaches a wireless transmission module connected to the computer platform, the wireless transmission module selective transmitting the diabetic ulcer diagnostic data to other computer devices (McCall: Fig. 17, ¶ 0135, wireless network hardware for communicating over a network with user devices and servers. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a wireless module into the device of the combination for the purpose of being able to provide the data wherever it is needed, including to various user devices (McCall: ¶ 0135)).
Regarding claim 5, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall further teaches wherein the body further includes a power source conductively connected to and powering the computer platform, camera and at least one illumination source (Hielscher: Figs. 7A-7G, inherent; Vick: col. 1, lines 31-43).
Regarding claims 6 and 7, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall further teaches wherein the camera detects visible light, wherein the diagnostic data includes multi-spectral imaging of at least one foot placed against the diagnostic pane (Hielscher: ¶ 0143, the light passing through window 150 of platform 132 – also see Figs. 7A-7C, supporting a foot, and ¶¶s 0082, 0112, 0135, 0077, etc., red and/or near-infrared light; also see McCall: ¶¶s 0007, 0063, 0064, etc., multi-spectral visible light being obvious to use as a results-effective variable based on suitability for a particular application. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claims 8-10, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall further teaches a second diagnostic device affixed to the body and selectively obtaining secondary diagnostic data from a foot placed on the diagnostic pane, wherein the second diagnostic device detecting one or a combination of: visible light, ultraviolet light, and infra-red light (McCall: ¶¶s 0062, 0063, 0073, ultraviolet, infrared, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate e.g. near-infrared capabilities for the purpose of being able to take advantage of increased photon penetration into the tissue (McCall: ¶ 0103), and for the purpose of more generally obtaining a comprehensive spectral assessment of the tissue (McCall: ¶ 0063)), wherein the second diagnostic device creating secondary diagnostic data from one of: optical coherence tomography, ultrasound scanning, Doppler scanning, autofluorescence, or laser speckle flowmetry (McCall: ¶¶s 0010, 0142, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an additional sensor response to ultrasound, for the purpose of providing data related to shape (McCall: ¶¶s 0010, 0142, etc.)).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hielscher-Vick-McCall in view of US Patent Application Publication 2017/0367580 (“DiMaio”).
Regarding claim 4, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall does not appear to explicitly teach wherein the computer platform is in wired communication with at least one other computer device and selectively transmits diabetic ulcer diagnostic data across the wired communication (although McCall does teach wireless communication in ¶ 0135).
DiMaio teaches wire communication as a known alternative to wireless communication (¶ 0248).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use wired communication instead of wireless communication as a simple substitution with predictable results (DiMaio: ¶ 0248, implementing data paths).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hielscher-Vick-McCall in view of US Patent Application Publication 2023/0081608 (“Muse”).
Regarding claim 11, Hielscher-Vick-McCall teaches all the features with respect to claim 1, as outlined above. Hielscher-Vick-McCall does not appear to explicitly teach wherein the diagnostic pane further includes foot aligning markings.
Muse teaches using foot alignment markings for properly positioning a foot (¶¶s 0062, 0064).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate foot alignment marking into the diagnostic pane of the combination, as in Muse, for the purpose of helping the user to property align their foot (Muse: ¶¶s 0062, 0064).
Claims 12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0125195 (“Hielscher”) in view of US Patent Application Publication 2020/0193580 (“McCall”).
Regarding claim 12, Hielscher teaches [a] method of diagnosing diabetic ulcers in a foot (¶¶s 0069, 0070, etc.), comprising: placing at least one foot against a diagnostic pane of a diabetic foot examination device (Figs. 7A-7C), the device comprised of: a body having a base and an upper structure (Fig. 7G, the base of the overall device, just above the wheels; Fig. 7G, the structure/walls defining chamber 130), the base including a generally horizontal support configured to rest on a generally planar surface (Fig. 7G, the bottom of the device is a horizontal support, configured to rest, via the wheels, on the floor (a generally planar surface)); a diagnostic pane located on the upper structure of the body, the diagnostic pane held at an angled relation to the base (Fig. 7G, platform 132, angled as shown), the diagnostic pane at least partially transparent to visible light and configured to support at least one foot placed thereupon (¶ 0143, the light passing through window 150 of platform 132 – also see Figs. 7A-7C, supporting a foot, and ¶¶s 0135, 0077, etc., red light); at least one camera affixed to the body and detecting illumination in the electromagnetic spectrum (Fig. 7G, camera 160), the camera positioned to view a foot placed against the diagnostic pane and generating diagnostic data from the detected illumination (Figs. 7A-7C, 11, etc.); at least one illumination source affixed to the body, the illumination source providing, at least, illumination in the electromagnetic spectrum directed at the diagnostic pane (Fig. 7G, light source 140, directed at platform 132 as represented by beam 142); and a computer platform in communication with the camera and illumination source (Fig. 7G, ¶ 0144, console 120 housing the optical components and all associated processors); illuminating the at least one foot from the illumination source (Fig. 7C, illumination beam 142); generating diagnostic data from the camera (Fig. 11); receiving the diagnostic data at the computer platform (Figs. 11, 7E, etc.); … .
Hielscher does not appear to explicitly teach detecting a presence of diabetic ulcers in the at least one foot based upon the received diagnostic data; and creating, at the computer platform, a diabetic ulcer diagnostic data (although Hielscher: ¶ 0074 describes identifying the origin of ulcerations, and ¶ 0133 describes diagnosing PAD).
McCall teaches detecting/diagnosing foot ulcers by imaging the foot (¶ 0057).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the imaging already contemplated to diagnose/detect foot ulcers, as in McCall, for the purpose of being able to diagnose an additional condition (and even its severity – McCall: ¶ 0057).
Regarding claims 14 and 15, Hielscher-McCall teaches all the features with respect to claim 12, as outlined above. Hielscher-McCall further teaches selectively transmitting the diabetic ulcer diagnostic data to other computer devices, including wirelessly transmitting diabetic ulcer diagnostic data (McCall: Fig. 17, ¶ 0135, wireless network hardware for communicating over a network with user devices and servers. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a wireless module into the device of the combination for the purpose of being able to provide the data wherever it is needed, including to various user devices (McCall: ¶ 0135)).
Regarding claim 16, Hielscher-McCall teaches all the features with respect to claim 12, as outlined above. Hielscher-McCall further teaches powering the computer platform, camera and at least one illumination source from a power source conductively connected thereto (Hielscher: Figs. 7A-7G, inherent).
Regarding claims 17-19, Hielscher-McCall teaches all the features with respect to claim 12, as outlined above. Hielscher-McCall further teaches selectively obtaining secondary diagnostic data from a second diagnostic device affixed to the body, the secondary diagnostic data of a foot placed on the diagnostic pane, wherein the second diagnostic device detecting one or a combination of: visible light, ultraviolet light, and infra-red light (McCall: ¶¶s 0062, 0063, 0073, ultraviolet, infrared, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate e.g. near-infrared capabilities for the purpose of being able to take advantage of increased photon penetration into the tissue (McCall: ¶ 0103), and for the purpose of more generally obtaining a comprehensive spectral assessment of the tissue (McCall: ¶ 0063)), wherein the second diagnostic device creating secondary diagnostic data from one of: optical coherence tomography, ultrasound scanning, Doppler scanning, autofluorescence, or laser speckle flowmetry (McCall: ¶¶s 0010, 0142, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an additional sensor response to ultrasound, for the purpose of providing data related to shape (McCall: ¶¶s 0010, 0142, etc.)).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hielscher-McCall in view of US Patent 7,497,037 (“Vick”).
Regarding claim 13, Hielscher-McCall teaches all the features with respect to claim 12, as outlined above. Hielscher-McCall does not appear to explicitly teach detecting at least one foot being placed on the diagnostic pane from at least one sensor connected to the computer platform
Vick teaches turning on a light when the presence of a foot is detected (col. 2, lines 15-31).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selectively turn on the illumination of Hielscher when the presence of a foot was detected, as in Vick, for the purpose of conversing power (Vick: col. 1, lines 37-43).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791