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 .
This Office Action is responsive to the Reply to Office Action filed July 18, 2025. The Examiner acknowledges the amendments to claims 1, 3, 4, 7, 8, 10 and 12, and the cancellation of claims 2, 5 and 19-23. Claims 1, 3-4 & 6-18 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed July 18, 2025, with respect to the claim objections of claims 7 & 8 and the rejection of claims 2, 8, 9 and 12 under 35 USC 112(b) have been fully considered and are persuasive. The previous claim objections of claims 7 & 8 been withdrawn.
Regarding the previous rejection of the claims under 35 USC 103 over Wilkes in view of Bahar, Applicant argues that there is no motivation or incentive for a person skilled in the art to consider substituting the visual indicator of Wilkes with the visual indicator of Bahar because Wilkes teaches a pressure sensing indicator with a completely different mechanism, in that Wilkes teaches the use of reduced-pressure therapy that applies negative or reduced pressure while the claimed pressure sensing device pertains to bandage compressive therapy where an external compressive pressure is exerted by the bandage. Additionally, Applicant argues that Bahar does not relate to an application for compressive bandage therapy, and that Bahar does not disclose the collapse of a rupture component when a desirable pressure is reached. Moreover, Applicant argues that the modification of Wilkes’ dressing reduced-pressure indicator with Bahar’s indicator destroys the utility of Wilkes because that would undermine the reusability and reversibility of Wilkes. Furthermore, Applicant argues that the combination of Wilkes and Bahar fails to teach a first subset of chambers configured to be collapsible to release a first visual indicator contained therein, when a bandage compressive pressure exerted on the plurality of chambers exceeds a first minimum pressure threshold for effective compression therapy.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that Bahar does not relate to an application for compressive bandage therapy, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Bahar is reasonably pertinent to the particular problem with which the inventor was concerned because Bahar teaches a plurality of chambers formed on a film for storing one or more visual indicators (i.e., a rupture component filled with liquid, such as dyes, gel, or air, that is designed to rupture at a specific pressure or force, and that is further formed on a non-adhesive film) (see Bahar, par 0006-0008, 0026, 0028, 0030-0031, figs. 1 & 2), a support layer for sealing the plurality of chambers to prevent and/or minimize leakage of the one or more visual indicators from said chambers (see Bahar, par 0032, 0040, fig. 2), wherein the plurality of chambers comprise a first subset of chambers configured to be collapsible to release a first visual indicator contained therein, and a second subset of chambers configured to be collapsible to release a second visual indicator contained therein (i.e., layers of indicators can be used together and as such a first layer of visual indicators and a second layer of visual indicators is released) (see Bahar, par 0027). Therefore, Bahar teaches compositions of visual indicators, which is reasonably pertinent to the claimed invention as the invention uses visual indicators in the pressure sensing device.
The examiner respectfully disagrees that the modification of Wilkes’ dressing reduced-pressure indicator with Bahar’s indicator destroys the utility of Wilkes because that would merely be the simple substitution of one type of visual indicator (i.e., the visual indicator of Bahar comprising a plurality of chambers filled with dye that release the dye when a pressure threshold has been exceeded) for another (i.e., the visual indicator of Wilkes comprising a moving member that moves when a pressure threshold has been exceeded), wherein the reduced-pressure assembly would still be able to function as disclosed in Wilkes. Furthermore, Wilkes discloses that the indicator can be configured to respond to positive pressures, and detect a threshold of positive pressure in a positive pressure system (see Wilkes, par 0062), therefore the system of Wilkes would be able to still function with the indicator of Bahar.
Moreover, applicant’s argument that Bahar fails to teach the collapse of a rupture component when a desirable pressure is reached is found to be unpersuasive because Bahar teaches that the indication component is configured to display an indication upon a specific pressure or force applied to the indicator, wherein the threshold can be set based on the type of material, set according to desired parameters (i.e., when a desirable pressure is reached) (see Bahar, par 0027 & 0030).
Nonetheless, the examiner agrees that the combination of Wilkes and Bahar fails to teach bandage compressive therapy where an external compressive pressure is exerted by the bandage. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art in view of applicant's amendments and arguments. See 35 USC 103 rejections below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 6-7, 10, 13 & 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20110092927 --as previously cited--, hereinafter referenced as "Wilkes" in view of US Patent Application Publication 20180339829 --as cited by applicant--, hereinafter referenced as "Bahar", in further view of US Patent Application Publication 20150224011, hereinafter referenced as “Scott”.
With respect to claim 1, Wilkes teaches a pressure sensing device for compressive therapy (see Wilkes, abstract, par 0001-0002), the device comprising, one or more visual indicators 101 and a wall 156 configured to be collapsible to move the visual indicator when the pressure exerted on a tissue site 102 exceeds a pressure threshold (i.e., a dressing reduced-pressure indicator that comprises a moving member that moves when pressure delivered to a tissue site of a user/patient by the device exceeds a pressure threshold, such that a wall of the moving member collapses and moves the moving member from an extended position to a retracted position (and vice versa when the pressure threshold has is no longer being exceeded) to visually indicate the exceeding of the pressure threshold) (see Wilkes, par 0047-0050, 0055, , figs. 1-3, 4A & 4B). Furthermore, Wilkes teaches that a plurality of dressing reduced-pressure indicators can be used with each of the dressing reduced-pressure indicators having a different pressure threshold (see Wilkes, par 0060-0062), and further that the indicators can be configured to respond to positive pressures, and detect a threshold of positive pressure in a positive pressure system (see Wilkes, par 0062).
Wilkes fails to teach the pressure sensing device comprises a plurality of chambers formed on a film for storing one or more visual indicators, a support layer for sealing the plurality of chambers to prevent and/or minimize leakage of the one or more visual indicators from said chambers, wherein the plurality of chambers comprise a first subset of chambers configured to be collapsible to release a first visual indicator contained therein, when the pressure exerted on the plurality of chambers exceed a first minimum pressure threshold for effective compression therapy, and a second subset of chambers configured to be collapsible to release a second visual indicator contained therein, when the pressure exerted on the plurality of chambers exceeds a second maximum pressure threshold for effective compression therapy, wherein the second maximum pressure threshold for effective compression therapy is higher than the first minimum pressure threshold for effective compression therapy. Wilkes further fails to teach bandage compressive therapy where an external compressive pressure is exerted by the bandage.
Bahar teaches a plurality of chambers formed on a film for storing one or more visual indicators (i.e., a rupture component filled with liquid, such as dyes, gel, or air, that is designed to rupture at a specific pressure or force, and that is further formed on a non-adhesive film) (see Bahar, par 0006-0008, 0026, 0028, 0030-0031, figs. 1 & 2), a support layer for sealing the plurality of chambers to prevent and/or minimize leakage of the one or more visual indicators from said chambers (see Bahar, par 0032, 0040, fig. 2), wherein the plurality of chambers comprise a first subset of chambers configured to be collapsible to release a first visual indicator contained therein, and a second subset of chambers configured to be collapsible to release a second visual indicator contained therein (i.e., layers of indicators can be used together and as such a first layer of visual indicators and a second layer of visual indicators is released) (see Bahar, par 0027). Furthermore, Bahar teaches the plurality of chambers are configured to display an indication upon a specific pressure or force applied to the indicator, wherein the threshold can be set based on the type of material, set according to desired parameters (i.e., when a desirable pressure is reached) (see Bahar, par 0027 & 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes such that the visual indicator is stored in a plurality of chambers, the system comprises a support layer for sealing the plurality of chambers, and further the plurality of chambers comprise a first subset of chambers configured to be collapsible to release a first visual indicator contained therein, and a second subset of chambers configured to be collapsible to release a second visual indicator contained therein because that would merely be the simple substitution of one type of visual indicator (i.e., the visual indicator of Bahar comprising a plurality of chambers filled with dye that release the dye when a pressure threshold has been exceeded) for another (i.e., the visual indicator of Wilkes comprising a moving member that moves when a pressure threshold has been exceeded).
Wilkes as modified by Bahar fails to explicitly teach a first minimum pressure threshold for effective compression therapy and a second maximum pressure threshold for effective compression therapy wherein the second maximum pressure threshold is higher than the first minimum pressure threshold, and further wherein the first subset of chambers releases a first visual indicator contained therein in response to applied pressure exceeding a first minimum pressure threshold, and wherein the second subset of chambers releases a second visual indicator contained therein in response to applied pressure exceeding a second maximum pressure threshold (i.e., the first subset of chambers has a different pressure threshold than the pressure threshold of the second subset of chambers). However, Wilkes as modified by Bahar does teach a plurality of dressing reduced-pressure indicators that can each have a different pressure threshold (see Wilkes, par 0060-0062). Further, Wilkes as modified by Bahar teaches that the threshold of applied pressure/force on the indicators can be adjusted based upon the desired application, type of material used, and other parameters such as material thickness, size, quality, shape, and/or density (see Bahar, par 0027 & 0030). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that there is a first minimum pressure threshold for effective compression therapy and a second maximum pressure threshold for effective compression therapy wherein the second maximum pressure threshold is higher than the first minimum pressure threshold because Wilkes as modified by Bahar teaches that a plurality of indicators can have distinct pressure thresholds (see Wilkes, par 0060-0062) and that the pressure thresholds can be set to any desired value (see Bahar, par 0027). Therefore, it would merely be a matter of routine optimization to arrive at a first minimum pressure threshold and a second maximum pressure threshold wherein the second maximum pressure threshold is higher than the first minimum pressure threshold, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that the first subset of chambers releases a first visual indicator contained therein in response to applied pressure exceeding a first minimum pressure threshold, and wherein the second subset of chambers releases a second visual indicator contained therein in response to applied pressure exceeding a second maximum pressure threshold because since the pressure thresholds can be set to any desired value (see Bahar, par 0027), using more than a single threshold would permit the system to better detect the applied pressure on the indicators.
Wilkes as modified by Bahar teaches the indicator can be configured to respond to positive pressures, and detect a threshold of positive pressure in a positive pressure system (see Wilkes, par 0062), but fails to explicitly teach bandage compressive therapy where an external compressive pressure is exerted by the bandage.
Scott teaches a compression garment 300 including a pressure sensor, wherein a controller of the compression garment includes an alarm indicator to provide an indication of pressure alarm conditions, such as an inability to produce intended pressures (see Scott, par 0031-0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that bandage compressive therapy where an external compressive pressure is exerted by the bandage is employed because bandage compression therapy provides pressure that promotes venous drainage in a patient’s extremities (see Scott, par 0021-0027), thereby promoting healing in any non-healing wounds the patient may have (see Scott, par 0003).
With respect to claim 3, Wilkes as modified by Bahar and Scott teaches the device according to claim 1. Wilkes as modified by Bahar fails to teach the first minimum pressure threshold is set at a level between 15 mmHg to 25 mmHg, and the second maximum pressure threshold is set at a level between 25 mmHg to 45 mmHg. However, Wilkes as modified by Bahar does teach that the threshold value may be set according to desired parameters based upon the desired application (see Bahar, par 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that the first minimum pressure threshold is set at a level between 15 mmHg to 25 mmHg, and the second maximum pressure threshold is set at a level between 25 mmHg to 45 mmHg because Wilkes as modified by Bahar teaches the threshold value can be set according to desired parameters (see Bahar, par 0027). Therefore, it would merely be a matter of routine optimization to arrive at a first minimum pressure threshold set at a level between 15 mmHg to 25 mmHg, and a second maximum pressure threshold set at a level between 25 mmHg to 45 mmHg, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 4, Wilkes as modified by Bahar and Scott teaches the device according to claim 1. Wilkes as modified by Bahar fails to teach the second maximum pressure threshold is at least 10 mmHg higher than the first minimum pressure threshold.
However, Wilkes as modified by Bahar does teach that the threshold value may be set according to desired parameters based upon the desired application (see Bahar, par 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that the second maximum pressure threshold is at least 10 mmHg higher than the first minimum pressure threshold because Wilkes as modified by Bahar teaches the threshold value can be set according to desired parameters (see Bahar, par 0027). Therefore, it would merely be a matter of routine optimization to arrive at a second maximum pressure threshold is at least 10 mmHg higher than the first minimum pressure threshold, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 6, Wilkes as modified by Bahar and Scott teaches the device according to claim 1. Wilkes as modified by Bahar and Scott fails to teach the plurality of chambers comprise walls having a thickness of from 1 pm to 10 pm.
However, Wilkes as modified by Bahar and Scott does teach that the thickness of the material used to form the indicator can be adjusted as to adjust the pressure threshold the indicator can withstand before displaying the indication (see Bahar, par 0027, 0030). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar and Scott such that the plurality of chambers comprise walls having a thickness of from 1 pm to 10 pm because Wilkes as modified by Bahar and Scott teaches the threshold value can be set according to the adjustment of parameters, such as the thickness of the material used to form the plurality of chambers of the indicators (see Bahar, par 0027, 0030). Therefore, it would merely be a matter of routine optimization to arrive at a thickness of 1 pm to 10 of the walls of the plurality of chambers, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 7, Wilkes as modified by Bahar and Scott teaches the device according to claim 1. Wilkes as modified by Bahar and Scott further teaches the plurality of chambers are formed on a film comprising a single layer of polymer (i.e., the indicator can be formed on a thin sheet of film such as plastic, rubber film, or a non-adhesive film) (see Bahar, par 0028).
With respect to claim 10, Wilkes as modified by Bahar and Scott teaches a method of making a pressure sensing device according to claim 1, the method comprising, forming a film comprising a plurality of chambers for storing one or more visual indicators (i.e., a non-adhesive film is formed with a plurality of rupture components filled with liquid, such as dyes, gel, or air, that is designed to rupture at a specific pressure or force) (see Bahar, par 0006-0008, 0026, 0028, 0030-0031, figs. 1 & 2), and applying a support layer to the film to prevent and/or minimise leakage of the one or more visual indicators from the plurality of chambers (see Bahar, par 0032, 0040, fig. 2), wherein the plurality of chambers are configured to release the one or more visual indicators when a pressure exerted on the plurality of chambers exceeds one or more pressure thresholds (i.e., the rupture components filled with liquid, such as dyes, gel, or air, are designed to rupture at a specific applied pressure or force) (see Bahar, par 0006-0008, 0026, 0028, 0030-0031, figs. 1 & 2), wherein the plurality of chambers comprise, a first subset of chambers configured to be collapsible to release a first visual indicator contained therein, and a second subset of chambers configured to be collapsible to release a second visual indicator contained therein (i.e., layers of indicators can be used together, and as such a first layer of visual indicators and a second layer of visual indicators is released) (see Bahar, par 0027).
Wilkes as modified by Bahar fails to explicitly teach a first minimum pressure threshold for effective compression therapy and a second maximum pressure threshold for effective compression therapy wherein the second maximum pressure threshold for effective compression therapy is higher than the first minimum pressure threshold for effective compression therapy, and further wherein the first subset of chambers releases a first visual indicator contained therein in response to applied pressure exceeding a first minimum pressure threshold for effective compression therapy, and wherein the second subset of chambers releases a second visual indicator contained therein in response to applied pressure exceeding a second maximum pressure threshold for effective compression therapy (i.e., the first subset of chambers has a different pressure threshold than the pressure threshold of the second subset of chambers). However, Wilkes as modified by Bahar does teach a plurality of dressing reduced-pressure indicators that can each have a different pressure threshold (see Wilkes, par 0060-0062). Further, Wilkes as modified by Bahar teaches that the threshold of applied pressure/force on the indicators can be adjusted based upon the desired application, type of material used, and other parameters such as material thickness, size, quality, shape, and/or density (see Bahar, par 0027). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/method of Wilkes as modified by Bahar such that there is a first minimum pressure threshold for effective compression therapy and a second maximum pressure threshold for effective compression therapy, wherein the second maximum pressure threshold is higher than the first minimum pressure threshold because Wilkes as modified by Bahar teaches that a plurality of indicators can have distinct pressure thresholds (see Wilkes, par 0060-0062) and that the pressure thresholds can be set to any desired value (see Bahar, par 0027). Therefore, it would merely be a matter of routine optimization to arrive at a first minimum pressure threshold and a second maximum pressure threshold wherein the second maximum pressure threshold is higher than the first minimum pressure threshold, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that the first subset of chambers releases a first visual indicator contained therein in response to applied pressure exceeding a first minimum pressure threshold, and wherein the second subset of chambers releases a second visual indicator contained therein in response to applied pressure exceeding a second maximum pressure threshold because since the pressure thresholds can be set to any desired value (see Bahar, par 0027), using more than a single threshold would permit the system to better detect the applied pressure on the indicators.
Wilkes as modified by Bahar teaches the indicator can be configured to respond to positive pressures, and detect a threshold of positive pressure in a positive pressure system (see Wilkes, par 0062), but fails to explicitly teach bandage compressive therapy where an external compressive pressure is exerted by the bandage.
Scott teaches a compression garment 300 including a pressure sensor, wherein a controller of the compression garment includes an alarm indicator to provide an indication of pressure alarm conditions, such as an inability to produce intended pressures (see Scott, par 0031-0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar such that bandage compressive therapy where an external compressive pressure is exerted by the bandage is employed because bandage compression therapy provides pressure that promotes venous drainage in a patient’s extremities (see Scott, par 0021-0027), thereby promoting healing in any non-healing wounds the patient may have (see Scott, par 0003).
With respect to claim 13, Wilkes as modified by Bahar and Scott teaches the method according to claim 10. Wilkes as modified by Bahar and Scott fails to teach that the step of forming the film comprises forming a plurality of chambers with walls having a thickness of from 1 pm to 10 pm.
However, Wilkes as modified by Bahar and Scott does teach that the thickness of the material used to form the indicator can be adjusted as to adjust the pressure threshold the indicator can withstand before displaying the indication (see Bahar, par 0027, 0030). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar and Scott such that the step of forming the film comprises forming a plurality of chambers with walls having a thickness of 1 pm to 10 pm because Wilkes as modified by Bahar and Scott teaches the threshold value can be set according to the adjustment of parameters, such as the thickness of the material used to form the plurality of chambers of the indicators (see Bahar, par 0027, 0030). Therefore, it would merely be a matter of routine optimization to arrive at a thickness of 1 pm to 10 of the walls of the plurality of chambers, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 15, Wilkes as modified by Bahar and Scott teaches a bandaging system comprising, one or more pressure sensing devices as defined in claim 1 (i.e., the pressure sensing device is comprised in a dressing) (see Wilkes, par 0029-0031, 0034, 0039-0040).
With respect to claim 16, Wilkes as modified by Bahar and Scott teaches the bandaging system according to claim 15. Wilkes further teaches a primary bandaging layer 116 (i.e., a sealing member) for covering a site of interest, wherein the one or more pressure sensing devices are arranged to be positioned on the primary bandaging layer (see Wilkes, par 0035-0038, fig. 1).
With respect to claim 17, Wilkes as modified by Bahar and Scott teaches the bandaging system according to claim 16. Wilkes further teaches one or more secondary bandaging layers 120, 122 for exerting pressure on the site of interest, wherein the one or more secondary bandaging layers 120, 122 are arranged to cover the one or more pressure sensing devices positioned on the primary bandaging layer (see Wilkes, par 0031, 0034, 0038).
With respect to claim 18, Wilkes as modified by Bahar and Scott teaches the bandaging system according to claim 17. Wilkes as modified by Bahar and Scott further teaches the one or more visual indicators are arranged to penetrate the one or more secondary bandaging layers to form one or more visually observable markings thereon when they are released from the plurality of chambers (i.e., the visual indicator is configured to break/rupture in the chamber to provide an indication that excessive force has been applied to the visual indicator, wherein the chamber has a cover that is rupture resistant such that the visual indicator is contained within the cover) (see Bahar, par 0026, 0029-0031, 0033, 0038).
Claim(s) 8-9 & 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkes in view of Bahar and Scott as applied to claim 1 & 10 above, and further in view of US Patent Application Publication 20160097769 --as previously cited--, hereinafter referenced as "Martin".
With respect to claim 8, Wilkes as modified by Bahar and Scott teaches the device according to claim 1. Wilkes as modified by Bahar and Scott fails to teach the plurality of chambers are formed on a film comprising alternating layers of polyanionic and polycationic polymer materials that are complementary to one another due to their opposite charges, wherein at least one alternating layer comprises polyanionic material selected from the group consisting of gum arabic, anionic polysaccharide, alginate, pectin, agar, carrageenan, polyacrylate, poly(4-styrenesulphonates), poly(vinylsulphonates), polyanetholesulphonates and combinations thereof, and wherein at least another alternating layer comprises polycationic material selected from the group consisting of gelatin, chitosan, whey proteins, albumin, beta- lactoglobulin, potato proteins, fava, legumin, soybean proteins, natural or synthetic polysaccharides, chitosan, poly(allylammmonium), poly(diallyldimethylammonium), poly(ethyleneimine) (PEI), polyl- lysine (PLL), poly(histidine), heparin, heparan sulfate, chondroitin sulfate, dextran sulfate, oxidized cellulose, polyaspartic acid, polyglutamic acid and combinations thereof.
Martin teaches materials and methods for assaying living cells, wherein polymeric materials such as cationic and anionic polymers are used (see Martin, par 0118). Alternating layers of polycationic and polyanionic solutions are used to generate polyelectrolyte multilayers that assemble via electrostatic or hydrogen bonding (see Martin, par 0118, 0124, 0130, fig. 17A). This results in films that are ultrathin and allows for film deposition of complex surface geometries (see Martin, par 0118). Polycationic materials used include poly-L-lysine and natural or synthetic polysaccharides such as chitosan (see Martin, par 0125), and polyanionic materials used include alginate, pectin, and carrageenan (see Martin, par 0126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wilkes as modified by Bahar and Scott such that the plurality of chambers are formed on a film comprising alternating layers of polyanionic and polycationic polymer materials that are complementary to one another due to their opposite charges, wherein at least one alternating layer comprises polyanionic material selected from the group consisting of gum arabic, anionic polysaccharide, alginate, pectin, agar, carrageenan, polyacrylate, poly(4-styrenesulphonates), poly(vinylsulphonates), polyanetholesulphonates and combinations thereof, and wherein at least another alternating layer comprises polycationic material selected from the group consisting of gelatin, chitosan, whey proteins, albumin, beta- lactoglobulin, potato proteins, fava, legumin, soybean proteins, natural or synthetic polysaccharides, chitosan, poly(allylammmonium), poly(diallyldimethylammonium), poly(ethyleneimine) (PEI), polyl- lysine (PLL), poly(histidine), heparin, heparan sulfate, chondroitin sulfate, dextran sulfate, oxidized cellulose, polyaspartic acid, polyglutamic acid and combinations thereof because the use of such materials results in films that are ultrathin and allows for film deposition of complex surface geometries (see Martin, par 0118).
With respect to claim 9, Wilkes as modified by Bahar, Scott and Martin teaches the device according to claim 8. Wilkes as modified by Bahar, Scott and Martin further teaches the film comprises at least 10 layers of polymers (see Martin, par 0130).
With respect to claim 11, Wilkes as modified by Bahar and Scott teaches the method according to claim 10. Wilkes as modified by Bahar and Scott fails to teach that prior to forming the film, a pattern template comprising a plurality of wells is fabricated, wherein said plurality of wells is a template for the plurality of chambers.
Martin teaches materials and methods for assaying living cells wherein polyelectrolyte multilayer films are prepared by the adsorption of alternating layers of polycationic and polyanionic aqueous solutions to a substrate that assemble through electrostatic or hydrogen bonding (see Martin, par 0124). The polyelectrolyte multilayers can coat substrates of any size or shape with defined properties of thickness, composition, or conformation (see Martin, par 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system/method of Wilkes as modified by Bahar and Scott such that prior to forming the film, a pattern template comprising a plurality of wells is fabricated, wherein said plurality of wells is a template for the plurality of chambers because it is known in the art that films such as polyelectrolyte multilayer films are fabricated on substrates that have any size, shape, or predefined property (such as wells that are used as a template for a plurality of chambers) (see Martin, par 0123).
With respect to claim 12, Wilkes as modified by Bahar, Scott and Martin teaches the method according to claim 11. Wilkes as modified by Bahar, Scott and Martin further teaches that the step of forming the film comprises depositing a polymeric material on the pattern template (i.e., substrate) to form a single layer of polymer, or depositing two or more polymeric materials in an alternating manner to form alternating layers of complementary polymers (see Martin, par 0123-0124).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkes in view of Bahar and Scott as applied to claim 10 above, and further in view of US Patent Application Publication 20180178538 --as previously cited--, hereinafter referenced as "Miyazawa".
With respect to claim 14, Wilkes as modified by Bahar and Scott teaches the method according to claim 10. Wilkes as modified by Bahar and Scott fails to teach the method further comprises loading one or more visual indicators into the plurality of chambers using an ink-jet printer or a solvent exchange technique.
Miyazawa teaches an inkjet printing device and inkjet printing method wherein the inkjet printing device comprises an inkjet discharging head including multiple nozzles to discharge ink, individual liquid chambers and a common liquid chamber that supplies ink to the individual liquid chambers (see Miyazawa, par 0039, 0209, 0213-0214).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wilkes as Bahar and Scott such that the method further comprises loading one or more visual indicators into the plurality of chambers using an ink-jet printer or a solvent exchange technique because it is known in the art that chambers can be loaded using ink-jet printing techniques (see Miyazawa, par 0039, 0209, 0213-0214).
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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791