Only 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 .
Claim Status
The amendment filed June 23rd, 2025 has been entered. Claims 1-16, 31, and 36-38 are currently pending in the application. Claims 1, 5, 6, 15, 16, and 31 have been amended. Claims 17-30 and 32-35 remain cancelled.
Response to Arguments
Applicant's arguments filed June 23rd, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument pertaining to claim 1 that Liu only teaches determining a physical change in a single direction and therefore Liu does not teach or suggest the processor in amended claim 1, this argument is considered moot, as Liu is no longer utilized to teach the processor, but rather the newly presented disclosure of Cerman, as seen below, is now being utilized.
Regarding applicant’s pertaining to claim 6 that Jackson does not teach “moves from a relaxed state…to a stretched state”, examiner does not find this argument persuasive as the claim language that the argument is relying upon is considered functional claim language describing the ability of the device to stretch and deform as the tissue to which it is attached moves or expands due to swelling. While Jackson does not expressly describe any such movement of its dressing occurring, the claim is currently drawn toward and apparatus claim and as such the claim is limited to what a device is and not what a device does. Consequently, the device of Jackson need only be capable of performing the claimed limitations, and as detailed in the below rejection of claim 6, the device of Jackson is seen to be capable of such movements as both of the dressing and the reference object are capable of stretching and relaxing based on the amount of force exerted on the device by its attached forces. The fact that the dressing is adhered to the patient’s skin results in any force exerted by the skin being transferred to the elastic membrane and consequently the reference object thereon. As such this limitation is seen to be disclosed/inherent to the device of Jackson.
Regarding applicant’s arguments pertaining to claim 31, the previous rejection relying on Liu as a primary reference has been withdrawn and is replaced with Jackson as applied to claim 1. As such the same reasoning applied to claim 1 is being applied to claim 31.
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 5,6, and 31 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the second region" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “the two or more regions” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitations “the first pair” in line 20 and “the second pair” in line 22. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-5, 31, 36, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al (U.S. Publication 2013/0190655) in view of Cerman (U.S. Publication 2017/0266370).
Regarding claim 1, Jackson discloses a system for monitoring (¶0077, periodic monitoring) wound closure (¶0054 wound closure), the system comprising: a dressing 980 for applying to the wound (¶0054 devices may be for wound treatment, uses include wound closure, ¶0055 controls mechanical environment of wound), the dressing comprising:
an elasticized membrane 985 having a first side (side opposite skin interfacing side) and a second side (¶0142 skin interfacing side; 910 skin interfacing side);
a reference object 990 disposed on the first side (¶0138 stamped, printed, or drawn on opposing side of sheet to adhesive) of the elasticized membrane, the reference object comprising a plurality of markings (990; ¶0142 plurality of radial lines) that respond to movement of underlying tissue when the dressing is applied to the wound (elastic characteristic of the membrane and ability of reference object to stretch and change shape as shown in Figs. 12a-c would respond to movement of underlying tissue when the dressing is applied to the wound) the plurality of markings including one or more line markings (¶0142 radial lines) and one point marking (center point at which lines 990 intersect) ; and
an adhesive (¶0142 skin adhesive) disposed on at least a portion of the second side (¶0142 skin interfacing side) of the elasticized membrane to adhere the elasticized membrane to an area of skin around the wound (¶0006 removably secured to a skin surface, ¶0055 provides physical barrier against contact, contaminants, and the like showing placed over wound and thus around);
wherein, when the dressing is applied to the wound (¶0143 describes process of adhering sheet to skin), in response to the movement of the underlying tissue (¶0143 applied to skin location it “may be allowed to at least partially recovery until a dynamic equilibrium between tensile stress in the skin and the elastic material of the sheet is reached” shows the response of the movement of the elastic membrane and corresponding reference objects to the movement and tension of the underlying skin/tissue), the elasticized membrane moves between a relaxed state (¶0143 dynamic equilibrium state) where the plurality of markings of the reference object have a first shape (example of Fig. 12c showing a respective dynamic equilibrium state of the reference lines) and a stretched state (Fig. 12B strained desired amount) where the plurality of markings of the reference object has a second shape (¶0143 symmetrical lines), the second shape being different (symmetrical vs dynamic equilibrium showing regions of stress on skin) than the first shape; and
wherein, the second shape being different than the first shape indicates a first change in a first physical dimension (dimension of line 990a) between a first pair of markings (pair of 990a line with center point marking creating by intersection of all lines) of the plurality of markings that indicates deformation of the elasticized membrane in a first direction (direction of line 990a) and a second change in a second physical dimension (dimension of 990b or c) between a second pair of markings (pair of line 990 b or c and center point where lines meet) of the plurality of markings that indicates deformation of the elasticized membrane in a second direction (deformation along direction of line 990 b or c), the deformation of the elasticized membrane being caused by the stresses of the underlying tissue (¶0143 deformation of elastic membrane based on the equilibrium reached between the elastic material tensile stress and the tensile stress of the skin); comparing the second shape of the plurality of markings to the first shape of the plurality of markings (the first shapes non-symmetrical appearance is compared to the original symmetric appearance of the second shape to determine the tensile stress in the skin ¶0143) and measuring (¶0143 relative size of lines when in first shape and second shape are compared and related to as less than or greater than and as such are measured through the assessment of relative size to one another) the first change between the first pair of markings indicating deformation of the elasticized membrane in the first direction and the second change between the second pair of markings indicated deformation of the elasticized membrane in the second direction (¶0143 size of each of the lines changes of lines assessed in order to determine the magnitude of inherent stresses as detailed by the disclosures of “The length of the line 990a in a first orientation is greater than the length of the line 990c transverse to the line 990a. Line 990c is the shortest. The length of the line 990b…with respect to lines 990a and 990c has a length between that of line 990aand 990c. Thus, the inherent stresses in the direction of line 990a are the greatest” which states that the greater the length of the line the greater the inherent stress; and based on measuring the first change and the second change, determine a degree of the stresses caused by the underlying tissue (¶0143 length of each of the directional lines is compared to one another to determine whether stresses are a greater or lesser degree of stress comparatively).
Jackson does not expressly disclose the deformation of the elasticized membrane being caused by swelling of the underlying tissue; a camera for capturing an image of the plurality of markings of the reference object when the plurality of markings have the second shape; or a processor configured to compare the second shape of the plurality of markings from the image to the first shape of the plurality of markings from a stored image and measure the first change between the first pair of markings indicating deformation of the elasticized membrane in the first direction and the second change between the second pair of markings indicating deformation of the elasticized membrane in the second direction; and based on measuring the first change and the second change, determine a degree of swelling of the underlying tissue.
Regarding the deformation of the elasticized membrane being caused by swelling of the underlying tissue, while the suggested system of Jackson does not directly disclose the deformation of the elasticized membrane being due to swelling of the area of skin around the wound, Jackson discloses periodically monitoring over a period of use of the device and over a period of healing and scar formation ¶0077 and that the tension of the device is used to manage endogenous stresses including stress induced at the wound site due to swelling ¶0055 and as such any swelling that occurs in the wound would inherently be detected in the monitoring of a previous strain indication to a future strain indication.
Furthermore, the limitation of “caused by swelling of the underlying tissue” constitutes functional claim language as it is used to denote the intended use of the device in regards to detecting swelling. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jackson discloses its ability to deform and be influenced by underlying tissue and endogenous stresses and as such is capable of the deformation occurring due to swelling.
Regarding the camera and the processor, Cerman, in the same field of endeavor of utilizing captured images to determine dimensional changes due to swelling, teaches utilizing a camera 163 to capture one or more images ¶0085 and compare images taken at different times, identify features present in the image (¶0079 identifies features of the patient’s skin), select any feature present for monitoring (¶0079, any feature present which is visible may be suitable for monitoring), and determine from the images whether features on the patient’s skin that are present in the images are moving apart, the distance between them increasing (¶0080), by counting the number of pixels that separate two features (¶0081), measuring the change between the features (¶0081 calculating the difference therebetween) and based on measuring the change between features determining a degree of swelling (determines presence of swelling through distance measurement) for the purpose of detecting swelling of the patient’s skin (Abstract, detection of swelling).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the dressing system of Jackson to have included the tissue swelling sensor 102 that includes the camera 163 and the processor (¶0078 processing) to perform the measurements disclosed by Jackson of the first change between the first pair of markings indicating deformation of the elasticized membrane in a first direction and the second change between the second pair of markings indicating deformation of the elasticized membrane in the second direction, and based on measuring the first change and the second change, and determine the change in dimension of these elements, as taught by Cerman, for the purpose of automating the manual process disclosed by Jackson. Furthermore, it would have been obvious to have correlated the determination of the change in dimension to a degree of swelling, as taught by Cerman, for the purpose of monitoring the endogenous stresses present at the wound to allow for better healing as disclosed by Jackson ¶0055. Jackson discloses periodically monitoring over a period of use of the device and over a period of healing and scar formation ¶0077 and that the tension of the device is used to manage endogenous stresses including stress induced at the wound site due to swelling ¶0055 and as such any swelling that occurs in the wound would inherently be detected in the monitoring of a previous strain indication to a future strain indication. Any measured value of strain that is greater than the previous would inherently be due to swelling of the wound and thus a determining of the difference between the images would be a determination of a degree of swelling and the deformation would be caused by the swelling. Thus, one of ordinary skill in the art would have been sufficiently motivated to apply the teachings of Cerman to the disclosure of Jackson to arrive at the current invention.
.
Regarding claim 3, Jackson in view of Cerman suggest the system of claim 1. Cerman further suggests the camera (163) and the processor (¶0078 processing) being part of a computing device (102, processing detecting, and alerting show computational ability of sensor 102).
Regarding claim 5, Jackson in view Cerman suggest the system of Claim 1. Jackson further discloses the reference object being a reticule (see examiner note below, Jackson includes length and width lines that are perpendicular to one another and constitute a series of fine lines used as a measuring scale) and a region including a series of horizontal lines for indicating deformation of the elasticized membrane in a first direction (horizontal length lines indicated deformation in length direction) and a vertical line (width line on second region side) for indicating deformation of the elasticized membrane in a second direction (indicated deformation in width direction).
Examiner notes that reticule is being defined according to ordinary meaning, e.g., the Oxford Dictionary definition of “a series of fine lines used as a measuring scale or an aid in locating objects”. The oxford dictionary further describes these lines as occurring in the eyepiece of an optical device or on the screen of an oscilloscope, but examiner has left out these requirements as the applicant has defined the reticule as being on the elastic membrane itself rather than part of a screen or optical device (¶0094 of applicant’s specification). The reference object of Jackson is thus considered a reticule as it is composed of a series of lines and is used to measure expansion of the bandage.
Jackson does not expressly disclose a second region containing a series of horizontal or vertical lines as Jackson only discloses one vertical and horizontal line.
However, in another embodiment (Figs. 2a1-b6), Jackson teaches a pattern utilizing a series of horizontal and vertical lines.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the line markings of the second region to include a series of vertical and horizontal lines that intersect as taught by Jackson for the purpose of expanding the sensitivity of detection of tension of the device, as incorporating more lines would have the beneficial effect of showing more details of the tension in the area.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the reference object of the current embodiment of Jackson that performs the function of allowing visualization of the strain of the elastic dressing for the tension lines of the embodiment depicted by Jackson in Fig. 2, since these elements perform the same function of allowing visualization of the strain of the dressing. Simply substituting one strain visualization means for another would yield the predictable result of allowing strain to be determined. See MPEP 2143.
Regarding claim 36, Jackson in view of Cerman suggest the system of claim 1. Jackson in view of Cerman does not expressly state that the dressing is “a stocking or compression stocking”.
However, the limitation of “a stocking or a compression stocking” is considered functional language based on the broadest reasonable definition of stocking provided by the Merriam-Webster dictionary that defines stocking as covering for the foot and leg, as such the terminology of stocking is seen to functionally describe the positioning of the bandage with regards to the patient anatomy to cover the foot and leg of the patient. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jackson in view Cerman suggest all the structure as claimed and Jackson further discloses the dressing being configured for use at a specific body location such at the foot ¶0061. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used as a stocking).
Claim(s) 2, 4, 31, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al (U.S. Publication 2013/0190655) in view of Cerman (U.S. Publication 2017/0266370) and further in view of Liu et al. (U.S. Publication 2015/0154451).
Regarding claim 2, Jackson in view of Cerman suggest the system of claim 1.
Jackson in view of Cerman do not expressly disclose or suggest the processor being remotely located and the camera further comprising a transmitter for transmitting the image to the processor over a network.
However, Liu, in the same field of endeavor of teaches the processor being remotely located (¶0037) and the camera further comprises a transmitter for transmitting (¶0010) the image (¶0037) to the processor over a network. Examiner notes that a network is being defined according to the oxford dictionary as a group or system of interconnected things, and therefore the transmission of the image is occurring over a network as disclosed by Liu.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor and camera of Jackson in view of Cerman to be remote and capable of transmitting the image to the remote processor respectively as taught by Liu since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of having the processor be in a location remote to the area of interest would have yielded predictable results of allowing the data to be processed and analyzed at a location remote to the patient. This capability would result in a multitude of potential benefits, including reducing the amount of equipment necessary at the patient site since the processor equipment would no longer be required at the site position, as well as allow monitoring of the condition by personnel not capable of being on site with the patient. See MPEP 2143. Furthermore, Cerman further teaches utilizing wireless technology in order to send information to remotely located devices (¶0115) which shows the capability of incorporating transmitting equipment into the present invention.
Regarding claim 4, Jackson in view of Cerman suggest the system of claim 1. Jackson does not expressly disclose the dressing comprising at least one container coupled to the second side of the elasticized membrane, the at least one container having a first end sealing coupled to the elasticized membrane, a second end spaced from the first end defining an opening of the container, and a continuous wall between the first end and the second end defining a volume of the container.
However, Liu, in the same field of endeavor of dressings containing indication markings for stretching of the dressing, teaches at least one container (¶0087 foam layer) coupled to the second side (¶0087 and ¶0088) of the elasticized membrane, the at least one container having a first end (end affixed to elastic substrate) sealingly coupled (¶0087, bonded) to the elasticized membrane, a second end (¶0088 exposed face) spaced from the first end defining an opening (¶0087, cells) of the container, and a continuous wall (body of foam) between the first end and the second end defining a volume of the container for the purpose of absorbing fluid ¶0087).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second side of the dressing of Jackson to have included the container taught by Liu for the purpose of absorbing any fluid coming from the wound which would provide a benefit of keeping the wound area in a dryer environment.
Regarding claim 31, Jackson discloses a system for monitoring (¶0077, periodic monitoring) wound closure (¶0054 wound closure), the system comprising: monitoring ¶0077 a dressing 950 for applying to the wound (¶0054 devices may be for wound treatment, uses include wound closure, ¶0055 controls mechanical environment of wound), the dressing comprising:
a reference object 965 disposed on an elasticized membrane 955 of the dressing applied to the wound comprising a plurality of markings (977 and 966), the dressing having an adhesive (¶0140 skin adhesive) to adhere the dressing to an area of skin around the wound (¶0140 skin adhesive), the plurality of markings being responsive to movement of underlying tissue (elastic characteristic of the membrane and ability of reference object to stretch and change shape as shown in Figs. 11a-c would respond to movement of underlying tissue when the dressing is applied to the wound), the elasticized membrane moves between a relaxed state (¶0143 dynamic equilibrium state) where the plurality of markings have a first shape (example of Fig. 11c showing a respective dynamic equilibrium state of the reference lines) and a stretched state (Fig. 11B strained desired amount) where the plurality of markings has a second shape (¶0143 symmetrical lines), the second shape being different (symmetrical vs dynamic equilibrium showing regions of stress on skin) than the first shape;
comparing the second shape of the plurality of markings to the first shape of the plurality of markings (the first shapes non-symmetrical appearance is compared to the original symmetric appearance of the second shape to determine the tensile stress in the skin ¶0143);
measuring (¶0141 distances measured to determine strain) a first change in a physical dimension between a first pair of markings (976) indicating deformation of the elasticized membrane in a first direction (L) and a second change in a physical dimension between a second pair of markings (977) indicating deformation of the elasticized membrane in a second direction (W); based on measuring the first change and the second change, determining a degree of tension inherent to the skin (¶0141 the amount of inherent skin tension transverse to lines 977, may be proportion r related to resulting length between lines 977, distances may be measured to determine strain).
Jackson does not expressly disclose the deformation of the elasticized membrane being caused by swelling of the underlying tissue; a computer processor coupled to a memory, wherein the computer processor performs the actions of receiving from a patient device image data representative of the second shape of the plurality of markings of the reference object disposed on the elasticized membrane of the dressing, comparing the second shape of the plurality of markings from the image to the first shape of the plurality of markings from a stored image; measuring of the first and second changes, determining the degree of swelling, or transmitting the degree of swelling and the image data to a physician device for assessment.
However, Cerman, in the same field of endeavor of utilizing captured images to determine dimensional changes due to swelling, teaches a computer processor (¶0078 tissue swelling sensor 102 processes images ¶0079, detects separation ¶0080) coupled to a memory (¶0080 compares images taken at different times so therefore has memory storage capabilities), wherein the computer processor is programmed to monitor swelling (tissue swelling sensor) by: receiving from a patient device image data representative of a second shape (¶0080 compare images taken at different times and determine whether features are moving apart, second shape equivalent to a second image where features have moved apart) of a plurality of reference objects (¶0081 features) disposed within the image, and compare the second shape from the image to a first shape of the plurality of reference objects from a stored image (¶0081 compares between two images taken at intervals ¶0078, with a previous image to the second image being consistent with a stored image); measuring the change in a physical dimension (¶0081 counts the number of pixels separating two features and thus measures the dimension between the features) between at least a pair pf features (¶0081 calculating the difference therebetween, ¶0081 separation of two features, ¶0079 any feature present which is visible may be suitable for monitoring) and based on measuring the change between at least a pair of features determining a degree of swelling (determines presence of swelling through distance measurement) and transmitting the degree of swelling to a device for assessment (¶0115 device 100 communicates wirelessly with other device with an instruction to provide an alert of swelling presence which indicates transmission) for the purpose of detecting swelling of the patient’s skin (Abstract, detection of swelling).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the dressing system of Jackson to have included the tissue swelling sensor 102 that includes the camera 163 and the processor (¶0078 processing) to perform the measurements disclosed by Jackson of the first change between the first pair of markings indicating deformation of the elasticized membrane in a first direction and the second change between the second pair of markings indicating deformation of the elasticized membrane in the second direction, and based on measuring the first change and the second change, determine the change in dimension of these elements, as taught by Cerman, for the purpose of automating the manual process disclosed by Jackson. Furthermore, it would have been obvious to have correlated the determination of the change in dimension to a degree of swelling, as taught by Cerman, for the purpose of monitoring the endogenous stresses present at the wound to allow for better healing as disclosed by Jackson ¶0055. Jackson discloses periodically monitoring over a period of use of the device and over a period of healing and scar formation ¶0077 and that the tension of the device is used to manage endogenous stresses including stress induced at the wound site due to swelling ¶0055 and as such any swelling that occurs in the wound would inherently be detected in the monitoring of a previous strain indication to a future strain indication. Any measured value of strain that is greater than the previous would inherently be due to swelling of the wound and thus a determining of the difference between the images would be a determination of a degree of swelling and the deformation would be caused by the swelling. Thus, one of ordinary skill in the art would have been sufficiently motivated to apply the teachings of Cerman to the disclosure of Jackson to arrive at the current invention.
Jackson in view of Cerman do not expressly disclose transmitting the image data for assessment.
However, Liu, in the same field of endeavor of dressings containing indication markings for stretching of the dressing, teaches transmitting image data of a bandage (¶0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor and camera of Jackson in view of Cerman to be remote and capable of transmitting the image to the remote processor respectively as taught by Liu since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of having the processor be in a location remote to the area of interest would have yielded predictable results of allowing the image data to be processed and analyzed at a location remote to the patient. This capability would result in allowing the user monitoring the bandage to send image data to a healthcare professional for verification . See MPEP 2143. Furthermore, Cerman further teaches utilizing wireless technology in order to send information to remotely located devices (¶0115) which shows the capability of incorporating transmitting equipment into the present invention.
Regarding claim 38, Jackson in view of Cerman suggest the system of claim 31.
Jackson in view of Cerman does not expressly state that the dressing is “a stocking or compression stocking”.
However, the limitation of “a stocking or a compression stocking” is considered functional language based on the broadest reasonable definition of stocking provided by the Merriam-Webster dictionary that defines stocking as covering for the foot and leg, as such the terminology of stocking is seen to functionally describe the positioning of the bandage with regards to the patient anatomy to cover the foot and leg of the patient. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jackson in view Cerman suggest all the structure as claimed and Jackson further discloses the dressing being configured for use at a specific body location such at the foot ¶0061. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used as a stocking).
Claim(s) 6, 15, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al (U.S. Publication 2013/0190655) in view of Bismuth et al. (U.S. Publication 2016/0252346).
Regarding claim 6, Jackson discloses a dressing 905 for applying to the wound (¶0047 at wound site), the dressing comprising:
an elasticized membrane 955 having a first side (906 side opposite skin interfacing side) and a second side (910 skin interfacing side);
a reference object 965 disposed on the second side (¶0138 stamped, printed, or drawn on side 910 under adhesive) of the elasticized membrane to visualize changes in shape of the elasticized membrane (¶0141 strain causes distances to change creating visual indication of strain), the reference object comprising a plurality of markings that respond to movement of underlying tissue when the dressing is applied to the wound (elastic nature of elastic sheet and the ability of the markings to change in size inherently would respond to movement of underlying tissue when applied to the wound, furthermore ¶0138 states that the sheet recovers until a dynamic equilibrium between tensile stress in the skin and the elastic material is reached showing effect of skin tension on the plurality of markings) and two or more regions (two dimensional objects can be divided into any number of regions as they have a two dimensional area and a region simply describes an area within an area) of markings (printed lines marking perimeter of reference object 965), the two or more regions including a first region having one or more vertical lines and one or more horizontal lines and a second region (see illustrative diagram of Figs. 11A-C below) ; and
an adhesive (¶0140 skin adhesive) disposed on at least a portion of the second side (910 skin interfacing side) of the elasticized membrane to adhere the elasticized membrane to an area of skin around the wound (¶0006 removably secured to a skin surface, ¶0055 provides physical barrier against contact, contaminants, and the like showing placed over wound and thus around);
wherein, when the dressing is applied to the wound (¶0138 describes process of adhering sheet to skin), in response to the movement of the underlying tissue (¶0138 applied to skin location it “may be allowed to at least partially recovery until a dynamic equilibrium between tensile stress in the skin and the elastic material of the sheet is reached” shows the response of the movement of the elastic membrane and corresponding reference objects to the movement and tension of the underlying skin/tissue), the elasticized membrane moves between a relaxed state (¶0143 dynamic equilibrium state) where the plurality of markings of the reference object have a first shape (example of Fig. 12c showing a respective dynamic equilibrium state of the reference lines) and a stretched state (Fig. 12B strained desired amount) where the plurality of markings of the reference object has a second shape (¶0143 symmetrical lines), the second shape being different (symmetrical vs dynamic equilibrium showing regions of stress on skin) than the first shape; and
wherein, the second shape being different than the first shape indicates a first change in a first physical dimension (dimension of line 990a) between a first pair of markings (pair of 990a line with center point marking creating by intersection of all lines) of the plurality of markings that indicates deformation of the elasticized membrane in a first direction (direction of line 990a) and a second change in a second physical dimension (dimension of 990b or c) between a second pair of markings (pair of line 990 b or c and center point where lines meet) of the plurality of markings that indicates deformation of the elasticized membrane in a second direction (deformation along direction of line 990 b or c), the deformation of the elasticized membrane being caused by the stresses of the underlying tissue (¶0143 deformation of elastic membrane based on the equilibrium reached between the elastic material tensile stress and the tensile stress of the skin).
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Illustrative diagram of Figs. 11A-C of Jackson (U.S. Publication 2013/0190655).
Regarding the limitations of “in response to movement of underlying tissue”, “moves from a relaxed state…to a stretched state” and “caused by swelling” these limitation are considered functional language (describes ability of device to stretch and thus move markings when underlying tissue moves due to swelling of underlying tissue based on applicants’ specification ¶0061). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jackson discloses all the structure as claimed, and is further capable of stretching and elongating according to forces applied to it. As such, it is capable of performing the functions as claimed (i.e., it is capable of being responsive to movement of underlying tissue such that the elasticized membrane moves from a relaxed state to a stretched state as the device is elastic and capable of stretching in response to any forces applied to it, and the deformation of the elasticized membrane being caused by swelling).
Jackson does not expressly disclose the two or more regions having different patterns of markings, the vertical and horizontal lines crossing, or the second region having at least one point marking spaced apart from other markings of the second region.
However regarding the different patterns of markings, Bismuth, in the same field of endeavor of determining strain levels of objects to be worn on the body through printed patterns on the object to be worn, further teaches using vertical and horizontal lines that cross (Figs. 5-8) as well as non-isomorphic patterns resulting in different patterns of markings in different regions of the dressing (¶0047-0049) for the purpose of detecting how much of the pattern cannot be seen in both X and Y directions by providing isomorphic patterns of X and Y dimension in non-isomorphic patterns (¶0047-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the line markings of the second region to include a series of vertical and horizontal lines that intersect as taught by Bismuth for the purpose of detecting how much of the pattern cannot be seen in both X and Y directions by providing isomorphic patterns of X and Y dimension non-isomorphic patterns (¶0047-49 of Bismuth).
Regarding the point marking in the second region, Bismuth, in the same field of endeavor of determining strain levels of objects to be worn on the body through printed patterns on the object to be worn, teaches utilizing a point marking (calibration chart ¶0103, example 2806) that is spaced apart from the other markings of the region in which its placed, yet still in the region of the other markings (¶0103 incorporated in the outfit together with the initial pattern, would be spaced apart in that the markings of the calibration chart are separated from the other markings in order to provide the image registration, distinct) for the purpose of enabling image registration ¶0103, and capturing the calibration chart together with the distorted pattern corresponding to the initial pattern in order to eliminate the distortion due to fabric stretch unrelated to depth variation on the object which allows for better calculation of depth variation in the area.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second region of Jackson to have included at least one point marking spaced apart from other markings in the second region for the purpose of providing a calibration marking that enables image registration ¶0103, and is captured together with the additional pattern of the second region in order to eliminate the distortion due to fabric stretch unrelated to depth variation on the object when calculating depth variation in the area.
Regarding claim 15, Jackson in view of Bismuth suggests the dressing of claim 6. Bismuth further suggests the reference object being a reticule (series of lines used for measuring) and the plurality of markings including a series of horizontal lines for indicating deformation of the elasticized membrane in the first direction and a series of vertical lines for indicating deformation of the elasticized membrane in the second direction.
Regarding claim 37, Jackson in view of Bismuth suggest the dressing of claim 6. Jackson in view of Bismuth does not expressly state that the dressing is “a stocking or compression stocking”.
However, the limitation of “a stocking or a compression stocking” is considered functional language based on the broadest reasonable definition of stocking provided by the Merriam-Webster dictionary that defines stocking as covering for the foot and leg, as such the terminology of stocking is seen to functionally describe the positioning of the bandage with regards to the patient anatomy to cover the foot and leg of the patient. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Jackson in view of Bismuth suggest all the structure as claimed and Jackson further discloses the dressing being configured for use at a specific body location such at the foot ¶0061. As such, it is capable of performing the functions as claimed (i.e., it is capable of being used as a stocking).
Claim(s) 7-9, 11-13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al (U.S. Publication 2013/0190655) in view of Bismuth et al. (U.S. Publication 2016/0252346) in view of Tyler et al. (U.S. Publication 2013/0060209).
Regarding claims 7, 9, 11-13, and 16 Jackson in view of Bismuth suggest the dressing of claim 6. Jackson further discloses a second membrane releasably coupled to the second side of the dressing via an attachment component (¶0059 release liner releasably attached to adhesive regions).
Jackson does not expressly disclose at least one container coupled to the second side of the elasticized membrane, the at least one container having a first end sealingly coupled to the elasticized membrane, and a second end spaced from the first end defining an opening of the container, and a continuous wall between the first end and the second end defining a volume of the container (Claim 7), a plurality of containers aligned between a first end and a second end of the elasticized membrane (Claim 9), the container having a circular shape and a height of 2 to 3 mm (Claim 11), the container comprising a medicament disposed in the volume of the container to be delivered to the wound when the dressing is applied to the wound (Claim 12), the medicament comprising a long acting analgesic drug, an anti-inflammatory drug and/or comprising an emollient designed to restore skin smoothness (Claim 13), or the second membrane being coupled to the second end of the at least one container.
However, Tyler, in the same field of endeavor of elastic bandages, teaches a dressing (Figure 11) comprising a plurality of containers (1130) having a first end sealingly coupled to an elasticized membrane (1110), and a second end spaced from the first end defining an opening of the container, and a continuous wall between the first end and the second end defining a volume of the container aligned between a first end and a second end of the elasticized membrane (1110);
the containers having a circular shape (¶0055 dotted);
the containers comprising a medicament (¶0023 drug compound) disposed in the volume of the container to be delivered to a wound when the dressing is applied for the purpose of incorporating a drug that can be topically administered to decrease swelling and pain;
the medicament comprising an anti-inflammatory drug (¶0023)
for the purpose of providing a pattern of container elements that increase efficacy and user comfort (abstract) that contain a drug that can be topically administered to decrease swelling and pain ¶0023.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dressing of Jackson to have included the plurality of containers comprising medicament as taught by Tyler for the purpose of providing a pattern of container elements that increase efficacy and user comfort (abstract) and that contain a drug that can be topically administered to decrease swelling and pain ¶0023.
Regarding the height of 2 to 3 mm (Claim 11), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the height of the container 2 to 3mm in order to fit the particular application since this claimed dimension of 2 to 3mm does not change the ability of container to absorb liquid (¶0087 of Liu describes absorbent function). Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Paragraph [0022] of applicant specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding the second membrane being coupled to the second end of the at least one container, the purpose of the second membrane disclosed by Jackson is to cover the adhesive meant to secure the device to the skin of the patient, as such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the adhesive and the release liner on the second end of the container which faces the skin of the patient as these components necessarily need to interact with the patient skin and the containers would be placed on the side of the elastic membrane facing the skin thus placement of the adhesive and liner on the second side of the container would have been obvious.
Regarding claim 8, Jackson in view of Bismuth and Tyler suggest the dressing of claim 7, Jackson further discloses an adhesive disposed such that the dressing can be removably attached to an area of skin around the wound.
It would have been obvious to one of ordinary skill in the art for this adhesive to have been disposed on the second end of the container which faces the skin around the wound when modifying the dressing of Jackson to include the containers of Tyler as the adhesive needs to be in contact with the skin and the device of Tyler is necessarily placed between the skin and the elastic membrane. As such the adhesive would naturally be placed at the second end of the containers of Tyler when modifying the device of Jackson to include containers of Tyler.
10. Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al (U.S. Publication 2013/0190655) in view of Bismuth et al. (U.S. Publication 2016/0252346) as applied to claim 6 and further in view of Liu et al. (U.S. Publication 2015/0154451).
Regarding claims 7 and 10, Jackson in view of Bismuth suggest the dressing of claim 6. Jackson in view of Bismuth do not expressly suggest at least one container coupled to the second side of the elasticized membrane, the at least one container having a first end sealingly coupled to the elasticized membrane, and a second end spaced from the first end defining an opening of the container, and a continuous wall between the first end and the second end defining a volume of the container (Claim 7), or the container being made of a foam-based material.
However, Liu, in the same field of endeavor of determining strain of a fabric through printed patterns, teaches at least one container (¶0088, foam layer) coupled to the second side (¶0088 first face) of the elasticized membrane, the at least one container having a first end (¶0088 face sealed to foam layer) sealingly coupled (¶0088 affixed) to the elasticized membrane, a second end (¶ exposed face) spaced (width of foam layer equals space between faces) from the first end defining an opening (¶0087, open cells) of the container, and a continuous wall (foam structure forming width) between the first end and the second end defining a volume (volume of open cells) of the container, wherein the container is made of a foam based material (¶0087, foam) for the purpose of absorbing fluid ¶0087).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second side of the dressing of Jackson to have included the container taught by Liu for the purpose of absorbing any fluid coming from the wound which would provide a benefit of keeping the wound area in a dryer environment.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al (U.S. Publication 2013/0190655) in view of Bismuth et al. (U.S. Publication 2016/0252346) in view of Tyler et al. (U.S. Publication 2013/0060209) and further in view of Wong et al. (U.S. Publication 2005/0118246) as evidenced by Williams et al. (See Advanced Drug Delivery Reviews article “Penetration enhancers attached to Final Office Action proceeding this action) and Quick (U.S. Patent NO. 4,390,442).
Regarding claim 14, Jackson in view of Bismuth and Tyler suggest the dressing of claim 12. Tyler further suggests the medicament comprising a long acting analgesic (¶0048, menthol and camphor added to embodiments), an anti-inflammatory (¶0023), and an emollient (¶0042 mentions glycol which is specified as propylene glycol as described in Williams et al “Penetration enhancers”, see highlight in attached document. Propylene glycol being an emollient is evidenced in Quick Col. 3 lines 11-16).
Jackson in view of Bismuth and Tyler do not expressly suggest the long acting analgesic, anti-inflammatory, and emollient being in separate layers or the position of such layers.
However, Wong, in the same field of endeavor of the application of drugs to the skin, teaches providing different drugs (¶0057 layers 78a-c) in separate layers for the purpose of controlling the release times of the drugs (¶0008 delaying release).
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 have included the long acting analgesic, anti-inflammatory, and emollient in separate layers as taught by Wong for the purpose of controlling the release times of the drugs (¶0008 of Wong).
Regarding the positioning of the layers with the long acting analgesic drug positioned adjacent to the second end of the container, the emollient at the first end of the container, and the anti-inflammatory therebetween, it would have been obvious to try to one of ordinary skill in the art at the time the invention was made to have the layers positioned as such since there are only a finite number of predictable solutions. Either the analgesic, emollient, or anti-inflammatory layers are positioned as a top, middle, or bottom layer. Wong teaches the ability to place different drugs within different layers (¶0057), therefore depending on the release time decided upon, any of the drugs could be placed as the top, middle, or bottom layer. Thus, placing the analgesic adjacent to the second end of the container, the emollient at the first end of the container, and the anti-inflammatory therebetween would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Jackson in view of Bismuth and Tyler further fails to suggest the anti-inflammatory being a gel.
However, Wong, in the same field of endeavor of the application of drugs to the skin, teaches providing gelling agents with dosage (¶0038).
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 have modified the anti-inflammatory suggest by Liu in view of Tyler to be in a gel form, as taught by Wong, for the purpose of stabilizing the drug layer formation by increasing its viscosity with a gelling agent.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781