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 .
Priority
Applicant claims the benefit of US Provisional Application No. 63322071, filed June 21, 2021. Claims 1-20 have been afforded the benefit of this filing date.
Information Disclosure Statement
The IDS dated 9/18/2024 and 3/11/2026 has been considered and placed in the application file.
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 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), 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):
(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.
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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
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), 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:
“the system comprising an acquisition device configured to acquire two or
more pictures (300, 300', 300") of a scene” in claim 15;
“the system comprising a processing device configured to carry out the
following method steps” in claim 15;
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites:
“in a marking step (101), the treatment area is marked on a skin of the patient and/or on a substrate which is separate from the skin of the patient” which can be reasonably interpreted as a human observer mentally marking a part of a skin of a patient.
“in an acquisition step (102), two or more pictures (300, 300', 300") of a scene are acquired, wherein the scene comprises the treatment area (201) marked in the marking step (101) and a predetermined reference symbol (202) having a predetermined reference area size” is a well-understood, routine, and conventional insignificant extra-solution activity of data gathering.
“in a detection step (103), closed contour areas (401) and the predetermined reference symbol (202) are detected in each of the pictures (300, 300', 300") acquired in the acquisition step (102)” which can be reasonably interpreted as a human observer mentally detecting an outline and symbol in an image.
“in a determination step (104), a closed contour area size is determined for each closed contour area (401) detected in the detection step (103) from the respective detected closed contour area (401) and the predetermined reference symbol (202) detected in the same picture (300, 300', 300") as the closed contour area (401)” which can be reasonably interpreted as a human observer mentally determining the size of a contour using the symbol and area as a reference.
“in a grouping step (105), the closed contour areas (401) detected in the detection step (103) are grouped according to their shape, thereby providing one or more groups (400, 400', 400") of closed contour areas (401)” which can be reasonably interpreted as a human observer mentally grouping together areas of similar shapes.
“in a characterization step (106), a characteristic area size (504) is determined for each group (400, 400', 400") of contour areas (401) identified in the grouping step (105) from the closed contour area sizes assigned to the closed contour areas (401) of each group (400, 400', 400")” which can be reasonably interpreted as a human observer mentally identifying a characteristic of each grouping.
“in storing step (108), the shape (502) and the characteristic area size (504) of the selected group (400, 400', 400") is stored in a database” is a well-understood, routine, and conventional insignificant extra-solution activity of data inputting.
Claim 2 recites “wherein the substrate (200) is a foil or a tracing paper or a patch, in particular a patch comprising capsaicin”. This is a is a well-understood, routine, and conventional insignificant extra-solution activity of a capsaicin patch.
Claim 3 recites “wherein in the marking step (101), the treatment area (201) is marked as an outline or is marked as a colored area”. A person with the aid of a pen and paper can mark an outline of a treatment area.
Claim 4 recites “wherein the predetermined reference symbol (202) is provided on the skin or on the substrate (200) or as a separate element”. This is a is a well-understood, routine, and conventional insignificant extra-solution activity of a marker.
Claim 5 recites “wherein the acquisition step (102), an orientation of an acquisition device acquiring the pictures is determined, in particular by a motion sensor”. A person can mentally determine the orientation of a camera for a picture. The motion sensor are parts that are adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea.
Claim 6 recites “wherein in the grouping step (105), the closed contour areas (401) detected in the detection step (103), in particular the shape and/or the closed contour area size of the closed contour areas (401) detected in the detection step, are compared to each other”. A person can mentally compare the shapes of contours with each other.
Claim 7 recites “wherein in the grouping step (105), the closed contour areas (401) detected in the detection step are grouped according to their shape into groups (400, 400', 400") having similar shape”. A person can mentally group contours based on their shapes.
Claim 8 recites “wherein in the determination step (104), the predetermined reference symbol (202) is used as a calibration standard for determining the closed contour area size in the respective picture (300, 300', 300")”. A person can mentally use a symbol as a reference to determine how big or small a contour area is in an image.
Claim 9 recites “wherein the characteristic area size (504) is a median area size or mean area size”. A person can mentally estimate a mean or median size of a group of contours.
Claim 10 recites “wherein the selection step (107) comprises displaying the one or more groups (400, 400', 400") determined in the grouping step (105) to a user”. Displaying the groups of contours is a well-understood, routine, and conventional insignificant extra-solution activity of data outputting.
Claim 11 recites “wherein the acquisition step (102) and the detection step (103) and the determination step (104) and the grouping step (105) and the characterization step (106) are repeated before a group (400, 400', 400") of contour areas is selected in the selection step (107)”. This is a well-understood, routine, and conventional insignificant extra-solution activity of repetition.
Claim 12 recites “wherein a photo (503) of the skin of the patient is taken, wherein the photo (503) is stored in the database in the storing step (108)”. This is a well-understood, routine, and conventional insignificant extra-solution activity of data inputting.
Claim 13 recites “wherein a pain intensity information (505) is received, wherein the pain intensity information (505) is stored in the database in the storing step (108)”. This is a well-understood, routine, and conventional insignificant extra-solution activity of data inputting.
Claim 14 recites “wherein characterized by a calculation step, in which a difference between the characteristic area size (504) of the selected group and a redetermined characteristic area size is calculated”. A person can mentally determine the difference between the contour sizes and a predetermined reference size.
Claims 15-19 corresponds to claims 1, 6-9 respectively, additionally reciting a system. The system are parts that are adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. Thus, they are rejected for the same reasons as claims 1, 6-9.
Claim 20 corresponds to claim 1, additionally reciting “cutaneous administration of capsaicin in a treatment area”. This is a well-understood, routine, and conventional insignificant extra-solution activity of a capsaicin treatment. Thus, they are rejected for the same reasons as claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-8, 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Xu (US 20070276195 A1) in view of Burgos (US 20180144212 A1).
Regarding claim 1, Xu discloses a method (100) for monitoring a treatment area of a patient, in particular a patient suffering from peripheral neuropathic pain, which patient is treated by cutaneous administration of a substance, in particular comprising capsaicin, in the treatment area (Xu, paragraph [0007], "A wound is generally defined as a break in the epithelial integrity of the skin. Such an injury, however, may be much deeper, including the dermis, subcutaneous fat, fascia, muscle, and even bone"), the method comprising the following method steps:
- in a marking step (101), the treatment area is marked on a skin of the patient and/or on a substrate which is separate from the skin of the patient (Xu, paragraph [0038], " In FIG. 1, patient 10 bearing wound 12 is shown with transparent/translucent film 14 carefully placed over wound 12 in order to establish a wound trace"),
- in an acquisition step (102), two or more pictures (300, 300', 300") of a scene are acquired (Xu, paragraph [0057], "Wound data display 40 may provide not only the data associated with the current image established on the display, but may also provide historical data suitable for identifying changes in the character of the wound over time", although not explicitly stated, as shown in Fig. 4, there are multiple dates that correspond to images being shot), wherein the scene comprises the treatment area (201) marked in the marking step (101) and a predetermined reference symbol (202) having a predetermined reference area size (Xu, paragraph [0043], "In FIG. 2, patient 10 bearing wound 12 is shown positioned appropriately to have wound 12 imaged by digital imaging device 42. Reference tag 32 is placed adjacent (but preferably outside) the perimeter of wound 12 and is thereby also captured within a digital image 44 of the wound site taken by digital imaging device 42 from a position generally normal to the plane of the wound 12"),
- in a detection step (103), closed contour areas (401) (Xu, paragraph [0064], "Thereafter, at Step 130, the processor identifies and locates the trace data associated with the line image that was traced around the periphery of the wound") and the predetermined reference symbol (202) are detected in each of the pictures (300, 300', 300") acquired in the acquisition step (102) (Xu, paragraph [0069], " Process 158 is initiated at Step 160 whereby the reference marker is located within the digital image of the wound site."),
- in a determination step (104), a closed contour area size is determined for each closed contour area (401) detected in the detection step (103) from the respective detected closed contour area (401) and the predetermined reference symbol (202) detected in the same picture (300, 300', 300") as the closed contour area (401) (Xu, paragraph [0045], "The reference tag 32 on the other hand is specifically designed to be easily recognizable to the image processor for the purpose of accurately determining the scale of the image. With the data associated with the trace and the reference tag image, the processor system within tablet PC 46 may then calculate the area of the wound and report it to the clinician on the display.").
While Xu teaches grouping the contours (Xu, paragraph [0052], “In FIG. 4, these historical wound traces are shown in dashed or broken outline form in a manner that would not only allow the caregiver to identify the rate at which healing is occurring, but also identify certain areas of the wound that may be healing faster than others”), they do not teach “- in a grouping step (105), the closed contour areas (401) detected in the detection step (103) are grouped according to their shape, thereby providing one or more groups (400, 400', 400") of closed contour areas (401)”.
However, Burgos teaches - in a grouping step (105), the closed contour areas (401) detected in the detection step (103) are grouped according to their shape, thereby providing one or more groups (400, 400', 400") of closed contour areas (401) (Burgos, paragraph [0103], "The clusters are obtained by comparing the shape information of the second images with each other to group the second images having close shape information.").
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to group the wounds of Xu’s images based on their shape, as taught by Burgos.
The suggestion/motivation for doing so would have been to ensure the wound in question is the same wound taken over time.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Xu in view of Burgos discloses - in a characterization step (106), a characteristic area size (504) is determined for each group (400, 400', 400") of contour areas (401) identified in the grouping step (105) from the closed contour area sizes assigned to the closed contour areas (401) of each group (400, 400', 400") (Xu, paragraph [0057], "Such information may, for example, include a wound area established at an initial measurement for a particular patient and a complete history of subsequent wound area measurements made on a periodic basis"),
- in a selection step (107), a group of closed contour areas (400, 400', 400") is selected (Xu, paragraph [0065], "After processing, the system of the present invention provides both an image display and references to the calculated values at Step 138;"),
- in storing step (108), the shape (502) and the characteristic area size (504) of the selected group (400, 400', 400") is stored in a database (Xu, paragraph [0015], "The images are then stored on the computer for later use, analysis and comparison").
Regarding claim 2, Xu in view of Burgos discloses the method according to claim 1, wherein the substrate (200) is a foil or a tracing paper or a patch, in particular a patch comprising capsaicin (Xu, paragraph [0038], " In FIG. 1, patient 10 bearing wound 12 is shown with transparent/translucent film 14 carefully placed over wound 12 in order to establish a wound trace").
Regarding claim 3, Xu in view of Burgos discloses the method according to claim 1, wherein in the marking step (101), the treatment area (201) is marked as an outline or is marked as a colored area (Xu, paragraph [0059], "At Step 106, the caregiver or technician then traces a wound outline with a felt tip pen on the transparent/translucent film in a manner that places as little pressure on the wound surface as possible").
Regarding claim 4, Xu in view of Burgos discloses the method according to claim 1, wherein the predetermined reference symbol (202) is provided on the skin or on the substrate (200) or as a separate element (Xu, paragraph [0067], "Image acquisition methodology 140 is initiated at Step 142 where the caregiver may visually inspect the wound and place an appropriate reference marker adjacent to or within the wound").
Regarding claim 5, Xu in view of Burgos discloses the method according to claim 1 wherein, in the acquisition step (102), an orientation of an acquisition device acquiring the pictures is determined, in particular by a motion sensor (Xu, paragraph [0067], "At Step 144, the clinician positions the digital imaging device (the digital camera) and confirms that view covers wound sections of concern as well as the reference marker").
Regarding claim 6, Xu in view of Burgos discloses the method according to claim 1, wherein in the grouping step (105), the closed contour areas (401) detected in the detection step (103), in particular the shape and/or the closed contour area size of the closed contour areas (401) detected in the detection step, are compared to each other (Burgos, paragraph [0103], "The clusters are obtained by comparing the shape information of the second images with each other to group the second images having close shape information.").
Regarding claim 7, Xu in view of Burgos discloses the method according to claim 1, wherein in the grouping step (105), the closed contour areas (401) detected in the detection step are grouped according to their shape into groups (400, 400', 400") having similar shape (Burgos, paragraph [0103], "The clusters are obtained by comparing the shape information of the second images with each other to group the second images having close shape information.").
Regarding claim 8, Xu in view of Burgos discloses the method according to claim 1, method according to claim 1, wherein in the determination step (104), the predetermined reference symbol (202) is used as a calibration standard for determining the closed contour area size in the respective picture (300, 300', 300") (Xu, paragraph [0045], "The reference tag 32 on the other hand is specifically designed to be easily recognizable to the image processor for the purpose of accurately determining the scale of the image. With the data associated with the trace and the reference tag image, the processor system within tablet PC 46 may then calculate the area of the wound and report it to the clinician on the display.").
Regarding claim 10, Xu in view of Burgos discloses the method according to claim 1, wherein the selection step (107) comprises displaying the one or more groups (400, 400', 400") determined in the grouping step (105) to a user (Xu, paragraph [0065], "After processing, the system of the present invention provides both an image display and references to the calculated values at Step 138;").
Regarding claim 11, Xu in view of Burgos discloses the method according to claim 1, wherein the acquisition step (102) and the detection step (103) and the determination step (104) and the grouping step (105) and the characterization step (106) are repeated before a group (400, 400', 400") of contour areas is selected in the selection step (107) (Xu, paragraph [0058], "This step (Step 130 in FIG. 6B and Step 162 in FIG. 7B below) may be repeated for any of a number of different wound traces that are discreetly identified within the region of interest").
Regarding claim 12, Xu in view of Burgos discloses the method according to claim 1, wherein a photo (503) of the skin of the patient is taken, wherein the photo (503) is stored in the database in the storing step (108) (Xu, paragraph [0015], "The images are then stored on the computer for later use, analysis and comparison").
Regarding claim 13, Xu in view of Burgos discloses the method according to claim 1, wherein a pain intensity information (505) is received, wherein the pain intensity information (505) is stored in the database in the storing step (108) (Xu, paragraph [0052], "In FIG. 4, these historical wound traces are shown in dashed or broken outline form in a manner that would not only allow the caregiver to identify the rate at which healing is occurring, but also identify certain areas of the wound that may be healing faster than others").
Regarding claim 14, Xu in view of Burgos discloses the method according to claim 1, wherein characterized by a calculation step, in which a difference between the characteristic area size (504) of the selected group and a predetermined characteristic area size is calculated (Xu, paragraph [0057], "Such information may, for example, include a wound area established at an initial measurement for a particular patient and a complete history of subsequent wound area measurements made on a periodic basis. In such a case, not only would the absolute value of the wound area be provided in this display, but percentage changes of this wound area may also be provided to allow the caregiver to more quickly discern the rate of healing that is occurring.").
Claims 15-18 corresponds to claims 1, 6-8 respectively, additionally reciting a system (Xu, paragraph [0019], “The systems of the present invention take advantage of ever more available and inexpensive digital imaging tools while at the same time recognizing that the most accurate discrimination tool is still the eye of the clinician”). Thus, they are rejected for the same reasons as claims 1, 6-8.
Claim(s) 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Xu (US 20070276195 A1) in view of Burgos (US 20180144212 A1) and in further view of Sayar (US 20220296097 A1).
Regarding claim 9, Xu in view of Burgos discloses the method according to claim 1.
Xu in view of Burgos does not teach “wherein the characteristic area size (504) is a median area size or mean area size”.
However, Sayar teaches wherein the characteristic area size (504) is a median area size or mean area size (Sayar, paragraph [0145], "At 902, the images of both eyes are received, and at 904 the images are analyzed and the size of the respective pupil is determined for each image or for a group of consecutive images, such that the pupil size is an average or a median of the pupil sizes in the group of consecutive images").
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application determine the average of Xu’s (in view of Burgos) wound outlines, as taught by Sayar.
The suggestion/motivation for doing so would have been to determine how major or minor future wound sizes are in comparison to the average.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Xu in view of Burgos and in further view of Sayar to obtain the invention as specified in claim 9.
Claim 19 corresponds to claim 9, additionally reciting a system (Xu, paragraph [0019], “The systems of the present invention take advantage of ever more available and inexpensive digital imaging tools while at the same time recognizing that the most accurate discrimination tool is still the eye of the clinician”). Thus, they are rejected for the same reasons as claim 9.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Xu (US 20070276195 A1) in view of Shlomo (US 20150045718 A1).
Regarding claim 20, Xu discloses a method for treatment of a patient suffering from peripheral neuropathic pain (Xu, paragraph [0007], "A wound is generally defined as a break in the epithelial integrity of the skin. Such an injury, however, may be much deeper, including the dermis, subcutaneous fat, fascia, muscle, and even bone").
Xu does not teach “the method comprising: cutaneous administration of capsaicin in a treatment area”.
However, Shlomo teaches the method comprising: cutaneous administration of capsaicin in a treatment area (Shlomo, paragraph [0003], "For example, the use of capsaicin-based patches, such as the Qutenza patch (NeurogesX, Inc., CA, USA) has been shown to have a long term effect which increases towards an optimal level over a couple of weeks").
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to provide a capasaicin-patch in place of Xu’s transparent film, as taught by Shlomo.
The suggestion/motivation for doing so would have been to provide relief for the patient.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Xu in view of Shlomo discloses monitoring said treatment area of said patient wherein: in an acquisition step (102), two or more pictures (300, 300', 300") of a scene are acquired, wherein the scene comprises the treatment area (201) (Xu, paragraph [0057], "Wound data display 40 may provide not only the data associated with the current image established on the display, but may also provide historical data suitable for identifying changes in the character of the wound over time"),
in a detection step (103), detecting closed contour areas (401) (Xu, paragraph [0064], "Thereafter, at Step 130, the processor identifies and locates the trace data associated with the line image that was traced around the periphery of the wound"),
determining a size and a location of a subsequent treatment area based on characterization of said closed contour areas (401) (Xu, paragraph [0045], "With the data associated with the trace and the reference tag image, the processor system within tablet PC 46 may then calculate the area of the wound and report it to the clinician on the display.").
Xu in view of Shlomo does not teach “cutaneous administration of capsaicin in said subsequent treatment area”.
However, Shlomo additionally teaches cutaneous administration of capsaicin in said subsequent treatment area (Shlomo, paragraph [0003], "For example, the use of capsaicin-based patches, such as the Qutenza patch (NeurogesX, Inc., CA, USA) has been shown to have a long term effect which increases towards an optimal level over a couple of weeks").
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to apply a capsaicin patch after outlining Xu’s (in view of Shlomo) wound, as additionally taught by Shlomo.
The suggestion/motivation for doing so would have been to provide more/less coverage of a patch depending on how much the wound has changed over time.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Xu with the additional teachings of Shlomo to obtain the invention as specified in claim 20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHANG whose telephone number is (571) 272-0245. The examiner can normally be reached Monday-Friday 10:00-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ms. Sumati Lefkowitz can be reached on (571) 272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WAYNE ZHANG/Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
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