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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p) because they include written descriptions of the figures when only reference characters, sheet numbers and/or view numbers are permitted (specifically, figure 10 includes the written description “Force” with a directional arrow instead of being depicted by a reference numeral and defined in the specification). Appropriate revision is required.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes legal phraseology (i.e. “comprises”; “comprising”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 8 and 11 are objected to because of the following informalities: in claims 8 and 11: “patient a temperature sensor” should be “patient with a temperature sensor”; In claim 11, a period “.” needs to be added at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557).
With respect to claim 1, Helm discloses method for monitoring a wound site of a patient (dressing 100 permits visual monitoring of a catheter system and insertion site – para [0061]; the insertion site is interpreted as being a wound site since it is the location at which there is a break in the skin), comprising the steps of applying a bandage to a wound site (the dressing includes adhesive on the skin facing surface and is applied over a catheter system and insertion site to seal and secure the system/site – see para [0055;0058] and monitoring elapsed time since application of said bandage (dwell time is monitored as described in para [0008] which therefore inherently requires monitoring of elapsed time since application).
Helm does not, however, disclose the steps of: applying a force to a breakable barrier to activate a time sensor at an initial time of application and monitoring elapsed time since application through total migration length of a fluid from a reservoir into a migration zone, said reservoir and said migration zone separated by said breakable barrier.
Bradley, however, teaches a timer device and method wherein a force (pressed by hand or dispensing machine – col 5 line 28-29) is applied to a breakable barrier (barrier 48) to activate a time sensor at an initial time (rupturing the barrier begins migration of the carrier mixture – col 5 lines 27-32) and monitoring elapsed time through total migration length of a fluid from a reservoir into a migration zone (carrier mixture migrates from a capsule 46 to and along absorptive layer 42 and progress is observed through gaps in the cover layer – col 5 lines 30-34; thus elapsed time is determined based on progress of the fluid migration), said reservoir (capsule 46) and said migration zone (absorptive layer 42) separated by said breakable barrier (barrier 48)(see col 5 lines 19-40; fig 6). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the bandage and method in Helm so that the bandage includes a timer device which is used by applying a force to a breakable barrier to activate a time sensor at an initial time of application and monitoring elapsed time since application through total migration length of a fluid from a reservoir into a migration zone, said reservoir and said migration zone separated by said breakable barrier, as taught by Bradley, in order to provide a means for indicating the expiration of a given length/amount of time which is directly related to the expiration of the usable life of the product (Bradley col 1 lines 43-65) and thereby alerts a user to when the product should be discarded/replaced.
With respect to claim 2, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 1) and Bradley further teaches the step of: breaking a frangible seam of said breakable barrier between said reservoir and said migration zone with the force (absorptive layer 42 is isolated from capsule 46 by seal 48, which is configured as a seam between the capsule 46 and layer 42 as shown in fig 6, whereby the seal 48 is ruptured by pressing on the capsule 46 – col 5 lines 19-40). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley to include the step of: breaking a frangible seam of said breakable barrier between said reservoir and said migration zone with the force, as taught by Bradley, in order to provide a means for indicating the expiration of a given length/amount of time which is directly related to the expiration of the usable life of the product (Bradley col 1 lines 43-65) and thereby alerts a user to when the product should be discarded/replaced.
With respect to claim 3, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 1) and Bradley further teaches the step of: demarking time through progression of a colored fluid from said reservoir into said migration zone with calibrated time points printed on said bandage (migration of the fluid across printed symbols on the surface makes the symbols appear – col 6 lines 62-66; the printed symbols are interpreted as being calibrated time points because elapsed time can be determined based on how long it takes for the fluid migration to progress to the point that the symbols are visible – also, different amounts of time can be indicated based on the progress of the symbols becoming visible i.e. partial visibility versus completely visible symbols give various time points; the fluid inherently is colored in order to be visible). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley to include the step of: demarking time through progression of a colored fluid from said reservoir into said migration zone with calibrated time points printed on said bandage, as taught by Bradley, in order to provide a means for indicating the expiration of a given length/amount of time which is directly related to the expiration of the usable life of the product (Bradley col 1 lines 43-65) and thereby alerts a user to when the product should be discarded/replaced.
With respect to claim 4, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 1) and Bradley further teaches that the step of applying a force further comprising the step of: applying a downward signing force across said frangible seam, said downward signing force sufficient to break said frangible seam (“pressing” on the capsule 46 to cause barrier 48 to rupture is interpreted as being a downwardly applied signing force since the user presses “down” onto the capsule during this process). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley so that the step of applying a force further comprises the step of: applying a downward signing force across said frangible seam, said downward signing force sufficient to break said frangible seam, as taught by Bradley, in order to provide a means for indicating the expiration of a given length/amount of time which is directly related to the expiration of the usable life of the product (Bradley col 1 lines 43-65) and thereby alerts a user to when the product should be discarded/replaced.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and further in view of Bourque et al (US 2004/0118710).
With respect to claim 5, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 3) and Helm further discloses the step of: peeling an adhesive backing off of said bandage (the dressing comprises an adhesive disposed on at least a portion of the bottom surface for attachment to the user’s skin and a protective sheet that covers the adhesive prior to deployment – para [0010]; the protective sheet is removed by peeling the sheet off the adhesive – para [0060]). Helm does not, however, disclose said step of peeling applying said force of breaking said frangible seam.
Bourque, however, teaches a device that has multiple compartments that are separated by a frangible seal wherein the mechanism of seal failure can include mechanisms such as delamination, rupture, differential peel, or interfacial peel (para [0045]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley so that peeling the adhesive backing off the bandage applies the force of breaking the frangible seam since Bourque teaches that rupture and peeling mechanisms are used interchangeably for causing failure of frangible seals. Additionally, one would have been motivated to cause failure of the seal by peeling rather than applying a downward force (i.e. pressing) on the device because the pressing force could apply unwanted pressure on an underlying surface which is avoided by using a peeling mechanism rather than applying a pressing force.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and further in view of Krupnick et al (US 2020/0054279).
With respect to claim 6, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 3) and Helm further discloses the step of applying a force further comprising the step of: securing a PICC line with an adhesive tape (tape 160 - para [0061]); and stretching said adhesive tape during said step of securing (it is inherent that tape is pulled or “stretched” during application to the skin so as to lie flat and avoid wrinkles),
Helm does not, however, disclose said step of stretching applying said force of breaking said frangible seam.
Krupnick teaches a bandage for use at an IV site wherein the bandage includes a breakable link configured to break or otherwise rupture in the event that the bridge section expands or stretches beyond a predetermined threshold (para [0008]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley so that the frangible seam breaks due to stretching, as taught by Krupnick, to thereby provide an easy means for breaking the seal/barrier to allow migration of the fluid from the reservoir to the migration zone without the need for applying a downward force (i.e. pressing) on the device which could also apply unwanted pressure on an underlying surface which is avoided by use of a stretching mechanism to break the seal rather than applying a pressing force.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and Krupnick et al (US 2020/0054279) and further in view of O’Mahony et al (WO 2018/115461 A1).
With respect to claim 7, Helm in view of Bradley and further in view of Krupnick discloses the method substantially as claimed (see rejection of claim 6) but does not disclose the step of: monitoring a pH of the wound site with a pH sensor at least partially embedded in said bandage.
O’Mahony, however, teaches a dressing which includes an internal sensor which is a pH sensor (see claim 5; the sensor being “internal” is interpreted to mean that it is embedded into the bandage; it is inherent that a pH sensor functions to monitor pH). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device and method of Helm in view of Bradley and further in view of Krupnick to include a pH sensor that is at least partially embedded in the bandage and is used for monitoring a pH of the wound site, as taught by O’Mahony, in order to assist with wound healing by facilitating the measurement of exudate pH to reflect the condition of a wound bed and aid in monitoring and determining the wound's response to treatment (O’Mahony pg 8 lines 1-3).
With respect to claim 8, Helm in view of Bradley and further in view of Krupnick discloses the method substantially as claimed (see rejection of claim 6) but does not disclose the step of: monitoring a temperature of the patient a temperature sensor at least partially embedded in said bandage.
O’Mahony, however, teaches a dressing which includes an internal sensor which is a temperature sensor (see claim 13; the sensor being “internal” is interpreted to mean that it is embedded into the bandage; it is inherent that a temperature sensor functions to monitor temperature). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device and method of Helm in view of Bradley and further in view of Krupnick to include a temperature sensor that is at least partially embedded in the bandage and is used for monitoring a temperature of the wound site, as taught by O’Mahony, in order to assist with wound healing by monitoring for elevated temperatures which can be indicative of wound infection (O’Mahony pg 1 lines 17-22).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and further in view of Garcia et al (EP 3669147 B1).
With respect to claim 9, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 1) but does not disclose the step of: rotating a valve to open the barrier.
Garcia, however, teaches a device that is configured such that when a rotational force is applied, a spring is pulled away from valve balls, causing the valve balls to move and permit passage through openings to allow a dye to move into a cavity – thus, in Garcia, rotating a valve device opens a barrier and permits fluid flow therethrough (see i.e. para [0029]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device and method of Helm in view of Bradley by replacing the seal/barrier 48 with a valve as taught by Garcia and then rotating the valve to open the barrier, as taught by Garcia, to thereby provide an easy means for allowing migration of the fluid from the reservoir to the migration zone without the need for applying a downward force (i.e. pressing) on the device which could also apply unwanted pressure on an underlying surface which is avoided by application of rotational force rather than pressing force.
With respect to claim 10, Helm in view of Bradley and further in view of Garcia discloses the method substantially as claimed (see rejection of claim 9) and Bradley further teaches the step of: demarking time through progression of a colored fluid from said reservoir into said migration zone with calibrated time points printed on said bandage (migration of the fluid across printed symbols on the surface makes the symbols appear – col 6 lines 62-66; the printed symbols are interpreted as being calibrated time points because elapsed time can be determined based on how long it takes for the fluid migration to progress to the point that the symbols are visible – also, different amounts of time can be indicated based on the progress of the symbols becoming visible i.e. partial visibility versus completely visible symbols give various time points; the fluid inherently is colored in order to be visible). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley to include the step of: demarking time through progression of a colored fluid from said reservoir into said migration zone with calibrated time points printed on said bandage, as taught by Bradley, in order to provide a means for indicating the expiration of a given length/amount of time which is directly related to the expiration of the usable life of the product (Bradley col 1 lines 43-65) and thereby alerts a user to when the product should be discarded/replaced.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and Garcia et al (EP 3669147 B1)and further in view of O’Mahony et al (WO 2018/115461 A1).
With respect to claim 11, Helm in view of Bradley and further in view of Garcia discloses the method substantially as claimed (see rejection of claim 10) but does not disclose monitoring a pH of the wound site with a pH sensor at least partially embedded in said bandage; and monitoring a temperature of the patient a temperature sensor at least partially embedded in said bandage.
O’Mahony, however, teaches a dressing which includes an internal sensor which is a pH sensor (see claim 5; the sensor being “internal” is interpreted to mean that it is embedded into the bandage; it is inherent that a pH sensor functions to monitor pH) and an internal sensor which is a temperature sensor (see claim 13; the sensor being “internal” is interpreted to mean that it is embedded into the bandage; it is inherent that a temperature sensor functions to monitor temperature). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device and method of Helm in view of Bradley and further in view of Garcia to include a pH sensor that is at least partially embedded in the bandage and is used for monitoring a pH of the wound site, as taught by O’Mahony, in order to assist with wound healing by facilitating the measurement of exudate pH to reflect the condition of a wound bed and aid in monitoring and determining the wound's response to treatment (O’Mahony pg 8 lines 1-3). Additionally, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device and method of Helm in view of Bradley and further in view of Garcia to include a temperature sensor that is at least partially embedded in the bandage and is used for monitoring a temperature of the wound site, as taught by O’Mahony, in order to assist with wound healing by monitoring for elevated temperatures which can be indicative of wound infection (O’Mahony pg 1 lines 17-22).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and further in view of O’Mahony et al (WO 2018/115461 A1).
With respect to claim 12, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 1) but does not disclose the step of: monitoring a pH of the wound site with a pH sensor at least partially embedded in said bandage.
O’Mahony, however, teaches a dressing which includes an internal sensor which is a pH sensor (see claim 5; the sensor being “internal” is interpreted to mean that it is embedded into the bandage; it is inherent that a pH sensor functions to monitor pH). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device and method of Helm in view of Bradley to include a pH sensor that is at least partially embedded in the bandage and is used for monitoring a pH of the wound site, as taught by O’Mahony, in order to assist with wound healing by facilitating the measurement of exudate pH to reflect the condition of a wound bed and aid in monitoring and determining the wound's response to treatment (O’Mahony pg 8 lines 1-3).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and O’Mahony et al (WO 2018/115461 A1) and further in view of Bourque et al (US 2004/0118710).
With respect to claim 13, Helm in view of Bradley and further in view of O’Mahony discloses the method substantially as claimed (see rejection of claim 12) and Helm further discloses the step of: removing an adhesive backing from said bandage (the dressing comprises an adhesive disposed on at least a portion of the bottom surface for attachment to the user’s skin and a protective sheet that covers the adhesive prior to deployment – para [0010]; the protective sheet is removed by peeling the sheet off the adhesive – para [0060]). Helm does not, however, disclose that removing the adhesive backing layer applies said force of breaking to said frangible seam.
Bourque, however, teaches a device that has multiple compartments that are separated by a frangible seal wherein the mechanism of seal failure can include mechanisms such as delamination, rupture, differential peel, or interfacial peel (para [0045]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method of Helm in view of Bradley and further in view of O’Mahony so that peeling the adhesive backing off the bandage applies the force of breaking the frangible seam since Bourque teaches that rupture and peeling mechanisms are used interchangeably for causing failure of frangible seals. Additionally, one would have been motivated to cause failure of the seal by peeling rather than applying a downward force (i.e. pressing) on the device because the pressing force could apply unwanted pressure on an underlying surface which is avoided by using a peeling mechanism rather than applying a pressing force.
With respect to claim 14, Helm in view of Bradley and O’Mahony and further in view of Bourque discloses the method substantially as claimed (see rejection of claim 13) and Helm further discloses the step of: covering a PICC line with said bandage (para [0061]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Helm et al (WO 2018005669A1) in view of Bradley et al (US 4408557) and further in view of Skinner (EP 1645856 A1)
With respect to claim 15, Helm in view of Bradley discloses the method substantially as claimed (see rejection of claim 1) but does not disclose the step of: controlling a movement of a liquid phase from said reservoir into said migration zone through application of at least one of a current and a voltage.
Skinner, however, teaches a time indicator that provides a high level of accuracy, is easy to read, and preferably allows for activation upon demand (para [0010]) comprising: a substrate, a fluid separated from the substrate until activation of the article enables the fluid to contact the substrate, the substrate being such that the fluid can migrate along said substrate at a rate dependent on time (para [0011]), and a conductive layer located adjacent to the surface of the substrate to be contacted by the fluid as it migrates along the substrate (para [0013]) wherein movement of the fluid is controlled through application of at least one of a current and a voltage (the fluid forms part of a resistor/power source and the conductive layer provides one electrode, whereby the resistance of the resistor or the voltage of the power source or the deliverable current of the power source varies with the progress of the fluid as it migrates along the substrate – para [0014]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device and method of Helm in view of Bradley so that the device further includes a conductive layer and is used by controlling a movement of a liquid phase from said reservoir into said migration zone through application of at least one of a current and a voltage, as taught by Skinner, in order to provide a time indicator that functions with a high level of accuracy, is easy to read, and preferably allows for activation upon demand.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786