DETAILED ACTION
Notice of Pre-AIA or AIA Status
Claims 1-7 are pending in this application.
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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,268,489, issued from parent application 18/216401. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed towards the use of projected light for detection of living subjects.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,730,383, issued from parent application 17/180,636. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed towards the use of projected light for detection of living subjects.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,959,628, issued from parent application 16/845,708. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed towards authentication systems using projected light.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Depfenhart et al. (US Patent 10,569,098 B2), hereby referred to as “Depfenhart”, in view of Flitsch et al. (US PGPub 2017/0119287 Al), hereby referred to as “Flitsch”.
Consider Claims 1, 6 and 7.
Depfenhart teaches:
1. A device comprising at least one processor that, in operation, / 6. A system comprising: / 7. A method comprising: (Depfenhart: abstract, The present invention relates to a therapy system for the treatment of the skin and subdermis with light. The system comprises a NIR light source which produces light with a wavelength adapted to an absorption maximum for exciting molecular oxygen in aqueous solution; an image recognition unit for detecting papillary end arterioles and their x-y-z coordinates, wherein a respective depth underneath the skin surface is determined as the z-coordinate by an autofocus function; an optical system for the optical coupling of the light of the NIR light source and the pattern recognition unit to the skin, with a focusing unit to controllably position the light with at least one focus point in the skin; and a control unit to control the NIR light source, the image recognition unit, and the optical system. Column 8 lines 55-67, Figure 1, FIG. 1 shows a schematic illustration of a therapy system according to the present invention, comprising a NIR light source and an image recognition system with a second light source and a camera, which are coupled to skin by an optical system.)
1. causes a light source to project pattern onto a target, the pattern being formed by first light,; / 6. a light source that, in operation, projects pattern onto a target, the pattern being formed by first light; / 7. causing a light source to project pattern onto a target, the pattern being formed by first light; (Depfenhart: Column 8 lines 55-67, Figure 1, FIG. 1 shows a schematic illustration of a therapy system according to the present invention, comprising a NIR light source and an image recognition system with a second light source and a camera, which are coupled to skin by an optical system. Column 9 lines 53-67 FIG. 1 shows a schematic illustration of a preferred therapy system for treating a volume like area of the skin with light. It should be understood that the term "skin" is used to generally refer to human tissue which extends from the epidermis up to in a depth of the dermis and in underlying tissue layers. Light refers to a focused light which is produced by a NIR light source 1, passed through an optical system 3 and behind an adapter plate 3b of the optical system 3 is emitted at least as a part of the light with a focal length and a corresponding focus point 4)
1. causes a photodetector to detect second light resulting from the projection of the pattern onto the target / 6. a photodetector that, in operation, detects second light resulting from the projection of the pattern onto the target; / 7. causing a photodetector to detect second light resulting from the projection of the pattern onto the target; (Depfenhart: column 9 lines 53-67, column 10 lines 1-38, FIG. 1 shows the skin with a contour of the papilla 10 and the end arterioles 12, which are connected to the arterial and venous blood vessels 13. A collagen tissue area 11 is indicated by a broken line and sketched lying between the papilla 10. The NIR light source produces the light with a first wavelength in an area of 532-1500 nm. The first wavelength is adapted to an absorption maximum for inducing molecular oxygen in aqueous solution…. An image recognition unit 2 is in the therapy system coupled to the skin, both via the optical system 3 and the adapter plate 3b. The image recognition unit 2 comprises a second light source for illuminating the skin, a camera unit for detecting the second light reflected on and in the skin, and a pattern recognition unit in addition to the image recognition.)
1. determines whether the target is a human skin or not based on the second light, performs a biometric authentication of the target, / 6. and at least one processor, wherein the at least one processor, in operation, determines whether the target is a human skin or not based on the second light, / 7. determining whether the target is a human skin or not based on the second light; (Depfenhart: column 10 lines 23-67, Figure 1, An image recognition unit 2 is in the therapy system coupled to the skin, both via the optical system 3 and the adapter plate 3b. The image recognition unit 2 comprises a second light source for illuminating the skin, a camera unit for detecting the second light reflected on and in the skin, and a pattern recognition unit in addition to the image recognition. With this a second light of the second light source with a second wavelength is produced in such a way that the second light penetrates at least up to the papillary end arterioles of the papillary blood vessels of the skin, so that the end arterioles are recognizable relative to the other tissue on the skin surface by an increased absorption or reflection, and can be recorded by the camera unit.)
1. performs a biometric authentication of the target, / 6. performs a biometric authentication of the target, / 7. performing a biometric authentication of the target; (Depfenhart: column 10 lines 38-67, Figure 1, The pattern recognition unit of the image recognition unit 2 comprises a first pattern recognition to recognize the 40 increased absorption or reflections by the end arterioles at the skin surface in an image of the camera unit, preferably either by dark or by bright areas in same. Recognition can take place here by a simple threshold value detection of the pixel intensities in the image. With this, by the first pattern recognition first of all respective x-y coordinates are determined in a plane parallel to the skin surface or to the adapter plate 3b. Preferably, the second light is projected on the skin as a dots array with a distance between the dots of 7-10 μm, so that less image information needs to be evaluated in the image of the camera unit, thereby saving time for the pattern recognition.)
1. and performs an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication. / 6. and performs an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication. / 7. and performing an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication. (Depfenhart: column 13 lines 28-42, Figures 3-4, FIG. 3 in a side view shows in outline the therapy unit with the optical system 3, the adapter plate 3b and skin in cross-section that lies underneath same. Also shown is the cone-shaped focused light of the NIR light source 1 with the resultant focus point 4. Underneath and above the cone dash lines each indicate a cone-shaped focused light, which would occur when the autofocus function changes the focus point 4 in the depth along the z-axis.)
Even if Depfenhart does not teach: performs an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication.
Flitsch teaches:
1. A device comprising at least one processor that, in operation,/ 6. A system comprising: /7. A method comprising: (Flitsch: abstract Device and methods for the incorporation of Quantum-Dots for spectroscopic analysis into biomedical devices are described. In some examples, the Quantum-Dots act as light emitters, light filters or analyte specific dyes. In some examples, a field of use for the apparatus and methods may include any biomedical device or product that benefits from spectroscopic analysis.)
1. causes a light source to project pattern onto a target, the pattern being formed by first light; / 6. a light source that, in operation, projects pattern onto a target, the pattern being formed by first light; / 7. causing a light source to project pattern onto a target, the pattern being formed by first light; (Flitsch: [0054] Referring to FIG. 1, an illustration of a quantum dot based non-invasive monitoring device is provided with exemplary illustration of skin layers depicted. A light source 190 may be used to irradiate the skin layers. There may be numerous spectral regions of interest that may be irradiated by the light source. In some examples, the light source 190 may project in numerous directions and each of these may include a different type of quantum dot element as will be described in following paragraphs. In other examples, the light source 190 may be a broad spectrum light source that traverses the skin layers to a detector element 191)
1. causes a photodetector to detect second light resulting from the projection of the pattern onto the target / 6. a photodetector that, in operation, detects second light resulting from the projection of the pattern onto the target; / 7. causing a photodetector to detect second light resulting from the projection of the pattern onto the target; (Flitsch: [0054] Referring again to the illustration, the epidermal layer 110 is illustrated on either side of the skin layers. The dermis layer 111 lies beneath the epidermal layer 110. There may be fluids and biomolecules or other analytes of interest that may be found in the top layers of the skin. As well, capillaries 120 may be found in this region. The subdermal layer 112 may have significant vascular structure 140 and fat tissue 130 as well as intra-tissue regions 150 that may be filled with fluid including various analytes. A light source 190 may be used to irradiate the skin layers. There may be numerous spectral regions of interest that may be irradiated by the light source.)
1. determines whether the target is a human skin or not based on the second light, performs a biometric authentication of the target, / 6. and at least one processor, wherein the at least one processor, in operation, determines whether the target is a human skin or not based on the second light, performs a biometric authentication of the target, / 7. determining whether the target is a human skin or not based on the second light; performing a biometric authentication of the target; (Flitsch: [0095] At step 830, one or both the non-invasive quantum dot device and the user interface may alert the user, and/or a practitioner, of the measured concentration. The alert may be programmed to occur when the levels measured are outside the predetermined threshold values programmed, received and/or calculated by the non-invasive quantum dot device. In addition, in some embodiments, the data and alerts may be analyzed to perform one or more steps of: a) change measurement frequency according to the time of the day, b) identify personal patterns in the changes of concentration levels measures, and c) change the measurement frequency according to the changes in concentrations measured)
1. and performs an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication. / 6. and performs an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication. / 7. and performing an individual authentication based on the determination whether the target is a human skin and result of the biometric authentication. (Flitsch: [0096] At step 840, patterns in changes of the concentration levels may be identified by the system. Using the identified patterns, the system may alert the user of causes and/or, at step 845, change the frequency according to the identified changes so that the system is more alert during critical identified conditions. Critical conditions can include events that would trigger a significant increase or decrease in glucose levels. Events can include, for example, holiday dates, exercise, location, time of the day, consumption of medicaments and the like.)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method and system for transcutaneous in-vivo tissue imaging and therapy proposed by Depfenhart to leverage Flitsch’s end-user GUI for multispectral medical imaging and analysis. The determination of obviousness is predicated upon the following findings: One skilled in the art would have been motivated to modify Depfenhart in order to improve the overall end-user interface for interactive clinical feedback through audible and visual interfaces such as speakers and the display. Furthermore, the prior art collectively includes each element claimed (though not all in the same reference), and one of ordinary skill in the art could have combined the elements in the manner explained above using known engineering design, interface and programming techniques, without changing a “fundamental” operating principle of Depfenhart, while the teaching of Flitsch continues to perform the same function as originally taught prior to being combined, in order to produce the repeatable and predictable result of enhancing its use for a clinical setting by incorporating a multi-faceted end user feedback. It is for at least the aforementioned reasons that the examiner has reached a conclusion of obviousness with respect to the claim in question.
Consider Claim 2.
The combination of Depfenhart and Flitsch teaches:
2. The device according to claim 1, wherein: the second light includes: reflected light that is reflected by the target; and scattered light that exits from inside of the target after entering the inside of the target and being scattered, and the at least one processor, in operation, determines whether the target is a human skin or not, based on the directly reflected light and the scattered light. (Depfenhart: column 10 lines 23-67, Figure 1, An image recognition unit 2 is in the therapy system coupled to the skin, both via the optical system 3 and the adapter plate 3b. The image recognition unit 2 comprises a second light source for illuminating the skin, a camera unit for detecting the second light reflected on and in the skin, and a pattern recognition unit in addition to the image recognition. With this a second light of the second light source with a second wavelength is produced in such a way that the second light penetrates at least up to the papillary end arterioles of the papillary blood vessels of the skin, so that the end arterioles are recognizable relative to the other tissue on the skin surface by an increased absorption or reflection, and can be recorded by the camera unit. Flitsch: [0054] Referring again to the illustration, the epidermal layer 110 is illustrated on either side of the skin layers. The dermis layer 111 lies beneath the epidermal layer 110. There may be fluids and biomolecules or other analytes of interest that may be found in the top layers of the skin. As well, capillaries 120 may be found in this region. The subdermal layer 112 may have significant vascular structure 140 and fat tissue 130 as well as intra-tissue regions 150 that may be filled with fluid including various analytes. A light source 190 may be used to irradiate the skin layers. There may be numerous spectral regions of interest that may be irradiated by the light source.)
Consider Claim 3.
The combination of Depfenhart and Flitsch teaches:
3. The device according to claim 1, wherein the pattern is dot pattern. (Depfenhart: column 10 lines 38-52, The pattern recognition unit of the image recognition unit 2 comprises a first pattern recognition to recognize the increased absorption or reflections by the end arterioles at the skin surface in an image of the camera unit, preferably either by dark or by bright areas in same. Recognition can take place here by a simple threshold value detection of the pixel intensities in the image. With this, by the first pattern recognition first of all respective x-y coordinates are determined in a plane parallel to the skin surface or to the adapter plate 3b. Preferably, the second light is projected on the skin as a dots array with a distance between the dots of 7-10 μm, so that less image information needs to be evaluated in the image of the camera unit, thereby saving time for the pattern recognition. Flitsch: [0054] Referring to FIG. 1, an illustration of a quantum dot based non-invasive monitoring device is provided with exemplary illustration of skin layers depicted. A light source 190 may be used to irradiate the skin layers. There may be numerous spectral regions of interest that may be irradiated by the light source. In some examples, the light source 190 may project in numerous directions and each of these may include a different type of quantum dot element as will be described in following paragraphs. In other examples, the light source 190 may be a broad spectrum light source that traverses the skin layers to a detector element 191)
Consider Claim 4.
The combination of Depfenhart and Flitsch teaches:
4. The device according to claim 1, wherein the biometric authentication includes at least one piece of authentication selected from the group consisting of fingerprint authentication, iris authentication, and vein authentication. (Depfenhart: column 10 lines 23-67, Figure 1, An image recognition unit 2 is in the therapy system coupled to the skin, both via the optical system 3 and the adapter plate 3b. The image recognition unit 2 comprises a second light source for illuminating the skin, a camera unit for detecting the second light reflected on and in the skin, and a pattern recognition unit in addition to the image recognition. With this a second light of the second light source with a second wavelength is produced in such a way that the second light penetrates at least up to the papillary end arterioles of the papillary blood vessels of the skin, so that the end arterioles are recognizable relative to the other tissue on the skin surface by an increased absorption or reflection, and can be recorded by the camera unit. Flitsch: [0054] Referring again to the illustration, the epidermal layer 110 is illustrated on either side of the skin layers. The dermis layer 111 lies beneath the epidermal layer 110. There may be fluids and biomolecules or other analytes of interest that may be found in the top layers of the skin. As well, capillaries 120 may be found in this region. The subdermal layer 112 may have significant vascular structure 140 and fat tissue 130 as well as intra-tissue regions 150 that may be filled with fluid including various analytes. A light source 190 may be used to irradiate the skin layers. There may be numerous spectral regions of interest that may be irradiated by the light source.)
Consider Claim 5.
The combination of Depfenhart and Flitsch teaches:
5. The device according to claim 1, wherein the photodetector is a camera that captures an image of the target, and both of the determination whether the target is a human skin or not and the biometric authentication are performed based on the image captured with the camera. (Flitsch: (0095] At step 830, one or both the non-invasive quantum dot device and the user interface may alert the user, and/or a practitioner, of the measured concentration. The alert may be programmed to occur when the levels measured are outside the predetermined threshold values programmed, received and/or calculated by the non-invasive quantum dot device. In addition, in some embodiments, the data and alerts may be analyzed to perform one or more steps of: a) change measurement frequency according to the time of the day, b) identify personal patterns in the changes of concentration levels measures, and c) change the measurement frequency according to the changes in concentrations measured. [0096] At step 840, patterns in changes of the concentration levels may be identified by the system. Using the identified patterns, the system may alert the user of causes and/or, at step 845, change the frequency according to the identified changes so that the system is more alert during critical identified conditions. Critical conditions can include events that would trigger a significant increase or decrease in glucose levels. Events can include, for example, holiday dates, exercise, location, time of the day, consumption of medicaments and the like.)
Conclusion
The prior art made of record in form PTO-892 and not relied upon is considered pertinent to applicant's disclosure.
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2674
/Tahmina Ansari/
September 19, 2026
/TAHMINA N ANSARI/Primary Examiner, Art Unit 2674
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