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 .
Status of Claims
Claims 1-8, 11, and 13-21 are pending and currently under consideration for patentability.
Claims 9, 10, and 12 are cancelled.
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive.
In response to the applicant’s arguments that the rejection is no long a 102 anticipation rejection, the examiner agrees, and the rejections is now under 103 with the same references.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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).
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 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) 1-6, 9-21 are rejected under 35 U.S.C. 103 as being unpatentable over Spinelli (US 20130267881 A1).
Regarding Claim 1, Spinelli discloses a vacuum sealed bandage (Paras. (0033]-(0034] Figs. 8a-b blister dressing 80; Para. (0061] FIG. 8) comprising: a first film material having adhesive on one side configured to be applied to skin and to adhere the first film material in an airtight arrangement with the skin (Paras. [0033]-(0034] Figs. 8a-b blister dressing 80; Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65, i.e. sealing adhesive band 65 is the first film having adhesive on one side and forms an airtight arrangement with skin 38);
a second film material extending from the first film material (Para. (0061] Figs. 8a-b sealed volume forming layer 81 ); and
a self-sealing valve extending from and sealingly attached to the second film material (Paras. [0033]-(0034] Figs. Ba-b blister dressing 80; Para. (0069]);
where the first film material, the second film material, and the self-sealing valve form a contiguous vacuum barrier when the self-sealing valve is closed (Paras. [0033]-(0034] Figs. 8a-b Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b) and form a volume 87 with relative vacuum over the blister 37 area; Para. [0069] sealed volume forming layers of the disclosed embodiments may be provided with port 88 shown in the embodiment 80 of FIG. 8(b) to allow the volume 87 of the deployed sealed volume forming layer 86 to be connected to an external vacuum, i.e. sealing adhesive band 65, volume forming layer 81 and valve 88 forms a contiguous vacuum barrier), the self-sealing valve is maintained closed except when the self-sealing valve is forced open by a removable device that increases vacuum pressure of the continguous vacuum barrier (Para. (0070) The port 88 can also be the type which allows puncturing by a needle which seals around the needle and reseals when the needle is removed ... A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume or withdraw any fluids in the volume or introduced into the volume, i.e. needle holds the self-sealing valve open), and the second film material is manipulable into multiple positions or arrangements (Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b), i.e. second film material 86 is manipulable into multiple positions or arrangements).
Spinelli further teaches where the removable device is having a removable medical syringe inserted into the self-sealing valve holding the self-sealing valve open (Para. (0070) The port 88 can also be the type which allows puncturing by a needle which seals around the needle and reseals when the needle is removed ... A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume or withdraw any fluids in the volume or introduced into the volume, i.e. needle holds the self-sealing valve open).
Spinelli further teaches where operation of the removable medical syringe creates negative pressure between a wound and the vacuum barrier when the first film material is in the airtight arrangement with the skin (Spinelli, Paras. [0061); (0069) Figs. 8a-b The blister dressing with sealed volume forming layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... port 88 provided with a one-way valve; Para. [0070) The port 88 can also be the type which allows puncturing by a needle which seals around the needle and reseals when the needle is removed ... A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume or withdraw any fluids in the volume or introduced into the volume, i.e. sealing adhesive band 65 forms an airtight arrangement with skin 38).
Spinelli fails to explicitly disclose where the negative pressure manipulates the second film material into the wound.
However in a secondary embodiment, Spinelli teaches where the negative pressure manipulates the second film material into the wound (Para. [0061) Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b) and form a volume 87 with relative vacuum over the blister 37 area; Para. (0069) every one of the sealed volume forming layers of the disclosed embodiments may be provided with a port (such as the port 88 shown in the embodiment 80 of FIG. 8(b)) to allow the volume 87 of the deployed sealed volume forming layer 86 to be connected to an external vacuum source; Para. [0072) In the schematics of FIGS. 9 (a)-9(c) the blister dressing assembly 10a does not have to be initially flat, and may assume any appropriate shape and configuration as dictated with the particular application ... the blister dressing assembly 10a may have a slight concavity (curved downward toward the skin) so that when the restraint is removed from the pressure applying layer 13, the same will deform downwards to apply the normal pressure to the skin and wound).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Spinelli to include where the negative pressure manipulates the second film material into the wound as taught by the secondary embodiment of Spinelli. The motivation for doing so would have been to provide an improved dressing for closing puncture wounds (Para. (00751)
Regarding Claim 2, Spinelli teaches a vacuum sealed bandage of claim 1. Spinelli further teaches where the first film material forms a perimeter about the second film material (Paras. [0033]-(0034] Figs. 8a-b blister dressing 80; Para. (0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65, i.e. as shown in Figs.Ba-Sb layer 65 forms a perimeter about the second film material 81 ).
Regarding Claim 3, Spinelli teaches a vacuum sealed bandage of claim 2. Spinelli fails to explicitly disclose where the second film material is loosely configured to be moved from one side of the first film material to the opposite side of the first film material through the perimeter formed by the first film material in the primary embodiment.
However in a secondary embodiment, Spinelli teaches where the second film material is loosely configured to be moved from one side of the first film material to the opposite side of the first film material through the perimeter formed by the first film material (Para. (0071) A schematic of a variation of the dressing shown in FIGS. 1 (a) to 1 (d) will now be described with regard to FIGS. 9(a)-9(c), generally referred to by reference numeral 1 0a ... The dressing 1 0a consists of a pressure applying section 11 a, which is surrounded by the adhesive "band" 12a ... The pressure applying section 11 a is shown to consist of a pressure applying layer 13 a similar to that shown and described with regard to the dressing of FIGS. 1 (a)-1 (d) ... The adhesive band 12a is permanently attached to the periphery of the pressure applying layer 13a using any method known in the art and may have a slight overlap to provide enough strength so that as the pressure applying layer deforms to apply normal pressure to the wound; Para. (0072) In the schematics of FIGS. 9(a)-9(c) the blister dressing assembly 10a does not have to be initially flat, and may assume any appropriate shape and configuration as dictated with the particular application; Para. (0073] the dressing 1 0a operates similarly to that of the dressing 10 shown in FIGS. 1 (a)-1 (d) except that the central portion thereof is configured to curve downward into the skin to apply a normal force to the wound, i.e. as shown in Figs. 1d and 9c, the volume forming layer can be moved from a first side of the adhesive band 12 to the opposite side through the perimeter formed by the adhesive band).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Spinelli to include where the second film material is loosely configured to be moved from one side of the first film material to the opposite side of the first film material through the perimeter formed by the first film material as taught by the secondary embodiment of Spinelli. The motivation for doing so would have been to provide an improved dressing for closing puncture wounds (Para. (0075]).
Regarding Claim 4, Spinelli teaches a vacuum sealed bandage of claim 1. Spinelli further teaches where the self-sealing valve extends from a first side of the vacuum barrier (Paras. (0033]-[0034] Figs. 8a-b blister dressing 80; Para. (0061] FIG. 8(a) The blister dressing with sealed volume forming
layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65; Para. (0069] the sealed volume forming layers of the disclosed embodiments may be provided with ... port 88 shown in the embodiment 80 of FIG. 8(b) to allow the volume 87 of the deployed sealed volume forming layer 86 to be connected to an external vacuum source ... The port 88 is preferably provided with a one-way valve, i.e. as shown in Fig. 8b the valve extends from a first side of the vacuum barrier formed by layers 65, 81 and valve 88) and is flush on a second side of the vacuum barrier (Para. (0061] FIG. 8(a) The blister dressing with sealed volume forming layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65; Para. (0069] the sealed volume forming layers of the disclosed embodiments may be provided with ... port 88 shown in the embodiment 80 of FIG. 8(b) to allow the volume 87 of the deployed sealed volume forming layer 86 to be connected to an external vacuum source ... The port 88 is preferably provided with a one-way valve, i.e. as shown in Figs. Ba and 8b the valve is flush with shape 86 formed by the sealed volume forming layer 81).
Regarding Claim 5, Spinelli teaches a vacuum sealed bandage of claim 4. Spinelli further teaches where the second film material extends from a side of the first film material in the same direction as the self-sealing valve extends from the first side of the vacuum barrier (Para. (0061] Figs. 8a-b The blister dressing with sealed volume forming layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65; Para. [0069] the sealed volume forming layers of the disclosed embodiments may be provided with ... port 88 provided with a one-way valve, i.e. as shown in Figs. 8a-b the valve extends from a first side of the vacuum barrier formed by layers 65, 81 and valve 88 extends from the top side of layer 81 and in the same direction as valve 88).
Regarding Claim 6, Spinelli teaches a vacuum sealed bandage of claim 1. Spinelli further teaches where the second film material is folded upon itself (Para. (0061) Figs. Ba-b sealed volume forming layer 81 is held in its pre-release (flattened) configuration and with stored mechanical potential energy by a partial or full ring type retaining element 82 ... Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8b, i.e. as shown in Figs. Ba, the sealed volume forming layer 81 is folded upon itself before being deployed).
Regarding Claim 11, Spinelli teaches a vacuum sealed bandage of claim 10. Spinelli further teaches where the removable medical syringe adjusts the amount of negative pressure between the wound and the vacuum barrier (Paras. (0061); (0069) Figs. 8a-b The blister dressing with sealed volume forming layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... port 88 provided with a one-way valve; Para. (0070) The port 88 can also be the type which allows puncturing by a needle which seals around the needle and reseals when the needle is removed ... A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used lo increase the vacuum in the volume).
Regarding Claim 13, Spinelli teaches a vacuum sealed bandage of claim 10. Spinelli fails to explicitly disclose where negative pressure is maintained between the second film material and the wound without a vacuum pump or does not require a power supply for operation.
However in a secondary embodiment, Spinelli teaches where the negative pressure adheres the second film material to the wound (Para. [0061) Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b) and form a volume 87 with relative vacuum over the blister 37 area; Para. (0069) every one of the sealed volume forming layers of the disclosed embodiments may be provided with a port (such as the port 88 shown in the embodiment 80 of FIG. 8(b)) to allow the volume 87 of the deployed sealed volume forming layer 86 to be connected to an external vacuum source; Para. (0071) A schematic of a variation of the dressing shown in FIGS. 1 (a) to 1 (d) will now be described with regard to FIGS. 9(a)-9(c), generally referred to by reference numeral 10a ... The dressing 10a consists of a pressure applying section 11a, which is surrounded by the adhesive "band" 12a ... The pressure applying section 11 a is shown to consist of a pressure applying layer 13 a similar to that shown and described with regard to the dressing of FIGS. 1(a)-1(d); Para. (0072) In the schematics of FIGS. 9(a)-9(c) the blister dressing assembly 10a does not have to be initially flat, and may assume any appropriate shape and configuration as dictated with the particular application ... the blister dressing assembly 10a may have a slight concavity (curved downward toward the skin) so that when the restraint is removed from the pressure applying layer 13, the same will deform downwards to apply the normal pressure to the skin and wound, i.e. as shown in Fig. 9c, the film 11 a is adhered to the wound).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Spinelli to include where the negative pressure adheres the second film material to the wound as taught by the secondary embodiment of Spinelli. The motivation for doing so would have been to provide an improved dressing for closing puncture wounds (Para. (0075)
Regarding Claim 14, Spinelli teaches a vacuum sealed bandage of claim 1. Spinelli further teaches that does not have a vacuum pump or does not require a power supply for operation (Spinelli, Paras. (0061); (0069) Figs. Ba-b The blister dressing with sealed volume forming layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... port 88 provided with a one-way valve; Para. (0070) A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume, i.e. as shown the vacuum is maintained without a power supply).
Regarding Claim 15, Spinelli discloses a method of applying a vacuum sealed bandage to a wound (Paras. (0033]-(0034] Figs. 8a-b blister dressing 80; Para. (0061] FIG. 8), the method comprising the steps of:
adhering a first film material having an adhesive on one side to a skin surface forming an airtight arrangement with the skin surface (Paras. [0033]-(0034] Figs. 8a-b blister dressing 80; Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65, i.e. sealing adhesive band 65 is the first film having adhesive on one side and forms an airtight arrangement with skin 38);
sealingly attaching a removable medical syringe to a self-sealing valve where the self-sealing valve is sealingly attached to a second film material that extends from the first film material where the first film material, the second film material, and the self-sealing valve form a contiguous vacuum barrier when the self-sealing valve is closed (Para. (0070) The port 88 can also be the type which allows puncturing by a needle which seals around the needle and reseals when the needle is removed ... A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume or withdraw any fluids in the volume or introduced into the volume, i.e. needle holds the self-sealing valve open);
creating negative pressure between the second film material and a wound in the skin by drawing air or fluid from between the contiguous vacuum barrier and the wound into the removable medical syringe wherein the self-sealing valve is maintained closed except when the self-sealing valve is forced open by the removable medical syringe when drawing the air or fluid and increasing the negative pressure (Paras. (0061); (0069));
manipulating the second film material into the wound by way of drawing air or fluid from between the contiguous vacuum barrier and the wound (Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b), i.e. second film material 86 is manipulable into multiple positions or arrangements); and
removing the removable medical syringe from the self-sealing valve where the self- sealing valve seals upon removal of the removable medical syringe (para [0033]-(0034] Figs. Ba-b blister dressing 80; Para. (0069]);.
Regarding Claim 16, Spinelli teaches the method of applying the vacuum sealed bandage to the wound of claim 15. Spinelli further teaches the method further comprising the step of: untwisting the second film material when manipulating the second film material into the wound wherein the second film material is in a twisted arrangement before the step of adhering (Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b), i.e. second film material 86 is manipulable into multiple positions or arrangements);.
Regarding Claim 17, Spinelli teaches the method of applying the vacuum sealed bandage to the wound of claim 15. Spinelli further teaches the method further comprising the step of: moving the second film material from one side of the first film material to the opposite side of the first film material having the adhesive when manipulating the second film material into the wound (Para. [0061] FIG. 8(a));.
Regarding Claim 18, Spinelli teaches the method of applying the vacuum sealed bandage to the wound of claim 15. Spinelli further teaches the method further comprising the step of: maintaining the negative pressure created between the second film material and the wound upon removing the removable medical syringe (0061); (0069));.
Regarding Claim 19, Spinelli teaches the method of applying the vacuum sealed bandage to the wound of claim 15. Spinelli further teaches the method further comprising the step of: tunneling the second film material into the wound (para [0073] the central portion thereof is configured to curve downward into the skin to apply a normal force to the wound).
Regarding Claim 20, Spinelli teaches the method of applying the vacuum sealed bandage to the wound of claim 15. Spinelli further teaches the method performed without a vacuum pump or does not require a power supply for operation (Spinelli, Paras. (0061); (0069) Figs. Ba-b The blister dressing with sealed volume forming layer 81 ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... port 88 provided with a one-way valve; Para. (0070) A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume, i.e. as shown the vacuum is maintained without a power supply).
Regarding Claim 21, Spinelli discloses a vacuum sealed bandage (Paras. (0033]-(0034] Figs. 8a-b blister dressing 80; Para. (0061] FIG. 8) comprising:
a first film material having adhesive on one side configured to be applied to skin and to adhere the first film material in an airtight arrangement with the skin (Paras. [0033]-(0034] Figs. 8a-b blister dressing 80; Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65, i.e. sealing adhesive band 65 is the first film having adhesive on one side and forms an airtight arrangement with skin 38);
a second film material extending from the first film material (Para. (0061] Figs. 8a-b sealed volume forming layer 81 ); and
a self-sealing valve extending from and sealingly attached to the second film material (Paras. [0033]-(0034] Figs. Ba-b blister dressing 80; Para. (0069)
where the first film material, the second film material, and the self-sealing valve form a contiguous vacuum barrier when the self-sealing valve is closed (Paras. [0033]-(0034] Figs. 8a-b Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b) and form a volume 87 with relative vacuum over the blister 37 area; Para. [0069] sealed volume forming layers of the disclosed embodiments may be provided with port 88 shown in the embodiment 80 of FIG. 8(b) to allow the volume 87 of the deployed sealed volume forming layer 86 to be connected to an external vacuum, i.e. sealing adhesive band 65, volume forming layer 81 and valve 88 forms a contiguous vacuum barrier), the self-sealing valve is maintained closed except when the self-sealing valve is forced open by a removable device that increases vacuum pressure of the continguous vacuum barrier (Para. (0070) The port 88 can also be the type which allows puncturing by a needle which seals around the needle and reseals when the needle is removed ... A vacuum can also be applied though such port, such as by withdrawing the piston of a needle syringe which pierces the port. Such can be used to increase the vacuum in the volume or withdraw any fluids in the volume or introduced into the volume, i.e. needle holds the self-sealing valve open), and the second film material is manipulable into multiple positions or arrangements (Para. [0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65 ... Once the blister dressing 80 is applied to the skin 38 over the blister 37 area, the user would remove/disengage/cut the retaining element 82, thereby allowing the sealed volume forming layer to be deployed and deform to the shape 86 shown in FIG. 8(b), i.e. second film material 86 is manipulable into multiple positions or arrangements).
and where the first film material forms a perimeter about the second film material and where the second film material is loosely configured to be moved from one side of the first film material to the opposite side of the first film material through the perimeter formed by the first film material Paras. [0033]-(0034] Figs. 8a-b blister dressing 80; Para. (0061] FIG. 8(a) The blister dressing is ... applied to the surface of the skin 38 over the blister 37 area by the sealing adhesive band 65, i.e. as shown in Figs.Ba-Sb layer 65 forms a perimeter about the second film material 81 )..
Claims 7 are rejected under 35 U.S.C. 103 as being unpatentable over Spinelli (US 20130267881 A1) in view of Smith (WO 2021/069290).
Regarding Claim 7, Spinelli teaches a vacuum sealed bandage of claim 1. ails to explicitly disclose where the first film material is more rigid than the second film material.
However, Smith is in the field of wound dressings (Smith, Abstract), and teaches where the first film material is more rigid than the second film material (Smith, Paras. (0007]; (0112] In some embodiments, the wound contact layer carries an adhesive portion on a lower surface thereof, the adhesive portion for forming a substantially fluid tight seal over a wound site. The wound contact layer may be perforated. In some embodiments, the cover layer is moisture vapor permeable ... The support layer may be positioned above the spacer layer. The support layer may have greater stiffness than the cover layer).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Spinelli to include where the first film material is more rigid than the second film material as taught by Smith. The motivation would have been to provide a conformable dressing for improving the healing rate of a wound (Smith, Para. (00071).
Claims 8 are rejected under 35 U.S.C. 103 as being unpatentable over Spinelli (US 20130267881 A1) in view of KCI (US 2020/0085632).
Regarding Claim 8, Spinelli teaches a vacuum sealed bandage of claim 1. Spinelli fails to explicitly disclose where the first film material is layered and the second film material extends from between the layers of the first film material.
However, KCI is in the field of negative pressure dressing materials (KCI. Abstract), and teaches where the first film material is layered and the second film material extends from between the layers of the first film material (Para. (0033) Referring now to FIGS. 1 & 2, an exploded perspective view of the dressing 104 is shown, according to an exemplary embodiment. The dressing 104 includes a plurality of layers, including a sealing adhesive layer 200 sealable around the wound bed 108, a perforated film layer 202 configured to abut the wound bed 108, a manifold layer 204 positioned along the perforated film layer 202 ... an adhesive drape 216; Para. [0046) adhesive drape 216 may also bind to the sealing adhesive layer 200, enclosing the manifold layer 204. i.e. film layer 202 extends between adhesive layers 200 and 216).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Spinelli to include where the first film material is layered and the second film material extends from between the layers of the first film material as taught by KCI. The motivation would have been provide an absorbent dressing that allows negative pressure to be maintained at a wound bed while enhancing the ability of the dressing to absorb fluid from the wound bed (KCI, Para. (00041).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is (571) 272-7159.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781