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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/3/2026 has been entered.
Claim Status
Claims 1, 3-6, 8-14, 16-21, 28-29, 33-34, 38, 43, 45-46, 62, and 73 remain pending in the present application. Claims 1 and 21 have been amended. Claims 2, 7, 15, 22-27, 30-32, 35-37, 39-42, 44, 47-61, 63-72, and 74 have been canceled.
Applicant’s amendments have been acknowledged, and overcome each and every claim objection previously set forth in the final office action mailed 1/5/2026, and thus all previous claim objections have been withdrawn.
Response to Arguments
Applicant’s arguments and amendments with respect to claims 1, 19, and 21 have necessitated new grounds of rejection. Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Locke remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Holm is being introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claims 1 and 21, as well as with respect to claim 19.
Cunningham, Wonder, Hammond, Spier, Knutson, Doshi, and Östan remain in the present rejection for disclosing and/or rendering obvious the limitations of the remaining claims.
Applicant also argues the cited references do not teach the support layer being “removably coupled” to an outer surface of the cover of the dressing, as now recited in claim 4.
However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, claim 4 does not require the structure enabling removability (i.e. as found in amended claims 1 and 21). Thus, the prior art would be capable of meeting the function as claimed.
Applicant’s arguments regarding claim 62 are similarly found not persuasive.
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.
Claims 1, 3, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (US 2015/0119832 A1), in view of Cunningham (US 6,129,715 A), Wonder et al. (US 5,072,738 A), and Holm et al. (US 2019/0231604 A1).
Regarding claim 1, Locke teaches a dressing (system 102 and dressing 124 in Fig. 1; Abstract) having a manifold (absorbent layer 184) and a cover disposed over the manifold (sealing member 140), wherein the manifold comprises a tissue-facing surface (bottom of absorbent layer 184; anti-microbial layer 190 and wicking layer 176 may also be interpreted as a bottom surface of the manifold) and an outward-facing surface (top of absorbent layer 184), the cover is disposed over the outward-facing surface of the manifold (Fig. 1 shows the sealing member 140 lying over the outward-facing surface of absorbent layer 184), the cover comprising a flange in proximity to the tissue-facing surface of the manifold (periphery 164).
Locke does not explicitly teach a skeleton support structure removably coupled to an outer surface of the flange; wherein the skeleton support structure comprises a base portion, configured to support the flange, and a projection portion, configured to extend over the manifold, and wherein the projection portion does not form a seal over the dressing.
Cunningham teaches a skeleton support structure for medical appliances (Fig. 1; Abstract), which is removable (Col. 4, lines 41-42), wherein the skeleton support structure comprises a base portion (side members 21 and 23), and a projection portion (cross and brace members 14 and 15) wherein the projection portion does not form a seal over the dressing (there are openings between the members, such as cavity 25 or opening 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise a skeleton support structure comprising a base portion and a projection portion, the projection portion configured to extend over the manifold and wherein the projection does not form a seal over the dressing. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination of Locke and Cunningham still do not explicitly teach the skeleton support structure coupled to an outer surface of the flange.
Wonder teaches a bandage wound dressing (Figs. 1-3, apparatus 10; Abstract), thus being in the same field of endeavor, comprising a dressing (foam pad 58) wherein the skeleton support structure extends from a dressing flange (best seen in Figs. 3-4; Col. 5, line 61 – Col. 6, line 3), and comprises rigid supports (supports 26/28; Col. 4, lines 30-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to an outer surface of the flange via support members as taught by Wonder. Doing so would thus comprise a base portion supporting the flange. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
The combination of Locke, Cunningham, and Wonder still do not explicitly teach the coupling of the skeleton support structure being by an adhesive.
Holm teaches a wound dressing delivery system (Figs. 1A and 6A; Abstract), thus being in the same field of endeavor, comprising a support structure (carrier 14 and 114) which is removably coupled to an outer surface of a cover flange (backing 116) by an adhesive to provide a reversible connection (¶s 25-27 and 35-38 describes how a low strength adhesive is sandwiched between the backing 16 and the carrier 14).
Thus, Holm shows that an adhesive is an equivalent structure known in the art. Therefore, because these two temporary securing means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the adhesive of Holm with the mechanical interfering arrangement of Locke, Cunningham, and Wonder.
Regarding claim 3, the combination of Locke, Cunningham, Wonder, and Holm substantially disclose invention of claim 1.
Cunningham further teaches the projection portion is coupled to the base portion (Col. 3, lines 18-22 indicate welding).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise a skeleton support structure wherein the projection portion is coupled to the base portion. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
Further, the limitations of the projection portion being “configured to form a handle for handling the dressing during placement” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Locke, Cunningham, Wonder, and Holm has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to be used for handing the dressing).
Regarding claim 73, Cunningham further teaches the projection portion is coupled to opposing sides of the base portion (best seen in Fig. 2).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support layer of Cunningham. Doing so with thus comprise the projection portion being coupled to opposing sides of the base portion. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
Claims 4-6, 8-9, 11, 17, and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, and Wonder.
Regarding claim 4, Locke teaches a dressing (system 102 and dressing 124 in Fig. 1; Abstract) having a manifold (absorbent layer 184) and a cover disposed over the manifold (sealing member 140), and a cover disposed over the manifold (Fig. 1 shows the sealing member 140 lying over the outward-facing surface of absorbent layer 184).
Locke does not explicitly teach a support layer coupled to an outer surface of the cover of the dressing and including a portion that extends over the manifold of the dressing, wherein the portion of the support layer that extends over the manifold does not form a seal over the dressing.
Cunningham teaches a skeleton support layer for medical appliances (Fig. 1; Abstract), which is removable (Col. 4, lines 41-42), wherein the skeleton support layer comprises a base portion (side members 21 and 23), and a projection portion that extends over the device (cross and brace members 14 and 15) wherein the projection portion does not form a seal over the dressing (there are openings between the members, such as cavity 25 or opening 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support layer of Cunningham. Doing so would thus comprise a skeleton support layer comprising a (projection) portion, the (projection) portion configured to extend over the manifold and wherein the projection does not form a seal over the dressing. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination of Locke and Cunningham still do not explicitly teach the support layer coupled to an outer surface of the cover of the dressing.
Wonder teaches a bandage wound dressing (Figs. 1-3, apparatus 10; Abstract), thus being in the same field of endeavor, comprising a dressing (foam pad 58) and a cover (fabric 40) wherein the skeleton support structure extends from an outer surface of the cover (best seen in Figs. 3-4; Col. 5, line 61 – Col. 6, line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support layer to an outer surface of the flange as taught by Wonder. Doing so would thus comprise the support layer coupled to an outer surface of the cover of the dressing. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
Further, the limitations of the support layer being “removably” coupled is considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Locke, Cunningham, and Wonder has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the support layer would be removable; see Col. 4, lines 41-42 of Cunningham).
Regarding claim 5, Cunningham teaches the support layer being a skeleton support structure (Fig. 1; Abstract).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise the support layer comprising a skeleton support structure. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
Regarding claim 6, Locke teaches the manifold comprises a first, tissue-facing surface (bottom of absorbent layer 184; anti-microbial layer 190 and wicking layer 176 may also be interpreted as a bottom surface of the manifold) and a second, outward-facing surface (top of absorbent layer 184), the cover is disposed over the outward-facing surface of the manifold (Fig. 1 shows the sealing member 140 lying over the outward-facing surface of absorbent layer 184), the cover comprising a flange, extending laterally away from the manifold, and proximity to the first surface of the manifold (periphery 164).
Wonder teaches the skeleton support structure that is configured to couple to the flange (best seen in Figs. 3-4; Col. 5, line 61 – Col. 6, line 3), and comprises rigid supports to support the flange of the cover (supports 26/28; Col. 4, lines 30-32).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to supporting flanges as taught by Wonder. Doing so would thus comprise Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
Regarding claim 8, Cunningham teaches a skeleton support structure for medical appliances (Fig. 1; Abstract), wherein the skeleton support structure comprises a plurality of supports coupled together (side members 21 and 23 with cross and brace members 14 and 15; Col. 3, lines 18-22 indicate welding); wherein the skeleton support structure is non-planar (Figs. 1-3 show how the support structure is 3-dimensional and thus is not planar) and is configured to extend without forming a seal (there are openings between the members, such as cavity 25 or opening 12).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham Doing so would thus comprise the skeleton support structure being non-planar and extending from the outer surface of the flange outward beyond the manifold. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
Regarding claim 9, Cunningham teaches the skeleton support structure comprises a base portion (side members 21 and 23), and a projection portion (cross and brace members 14 and 15) wherein the projection portion does not form a seal over the dressing (there are openings between the members, such as cavity 25 or opening 12).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise a skeleton support structure comprising a base portion and a projection portion, the projection portion configured to extend over the manifold and wherein the projection does not form a seal over the dressing. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
Wonder teaches the skeleton support structure extends from a dressing flange (best seen in Figs. 3-4; Col. 5, line 61 – Col. 6, line 3), and comprises rigid supports (supports 26/28; Col. 4, lines 30-32).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to an outer surface of the flange via support members as taught by Wonder. Doing so would thus comprise a base portion supporting the flange. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
Regarding claim 11, Cunningham further teaches the skeleton structure comprises a plurality of supports coupled together into a unitary skeleton support structure (side members 21 and 23 with cross and brace members 14 and 15; Col. 3, lines 18-22 indicate welding).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise the skeleton support structure comprising a plurality of supports coupled together into a unitary skeleton support structure. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
Regarding claim 17, Cunningham discloses the skeleton support structure may be made of steel (Col. 3, lines 26-30).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise the skeleton support being made of steel. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination of Locke, Cunningham, and Wonder do not explicitly disclose the skeleton support structure being wire with a diameter of about 1-1.5 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Locke, Cunningham, and Wonder to have a diameter of 1-1.5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Locke, Cunningham, and Wonder would not operate differently with the claimed skeleton diameter. Further, applicant places no criticality on the range claimed (¶ 100 of Applicant specification indicates the claimed ranges only in “some embodiments”).
Regarding claim 62, Locke teaches a dressing (system 102 and dressing 124 in Fig. 1; Abstract) a cover disposed over a manifold (sealing member 140 and absorbent 184).
Locke does not explicitly teach a skeleton support structure having a base portion which is configured to support a perimeter of the cover, and a projection portion which is configured to extend from the base portion over the manifold without forming a seal; and the base portion of the skeleton support structure being removably attached to an upper surface of the cover.
Cunningham teaches a skeleton support layer for medical appliances (Fig. 1; Abstract), which is removable (Col. 4, lines 41-42), wherein the skeleton support layer comprises a base portion (side members 21 and 23), and a projection portion that extends over the device (cross and brace members 14 and 15) wherein the projection portion does not form a seal over the dressing (there are openings between the members, such as cavity 25 or opening 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support layer of Cunningham. Doing so would thus comprise a skeleton support layer comprising a projection portion, the projection portion configured to extend over the manifold and wherein the projection does not form a seal over the dressing. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination of Locke and Cunningham still do not explicitly teach the skeleton support structure being configured to support the perimeter of the cover and removably attaching the base portion of the skeleton support structure to an upper surface of the cover
Wonder teaches a bandage wound dressing (Figs. 1-3, apparatus 10; Abstract), thus being in the same field of endeavor, comprising a dressing (foam pad 58) wherein the skeleton support structure extends from a dressing flange (best seen in Figs. 3-4; Col. 5, line 61 – Col. 6, line 3), and comprises perimeter supports (support members 26/28, Col. 4, lines 30-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to an outer surface of the flange as taught by Wonder. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Locke, Cunningham, and Wonder teaches all the claimed structure, and further teaches the base portion and the wound dressing being separable. Thus, the combination would necessarily require the steps of providing a dressing having a cover disposed over a manifold; forming a skeleton support structure having a base portion which is configured to support a perimeter of the cover, and a projection portion which is configured to extend from the base portion over the manifold; and removably attaching the base portion of the skeleton support structure to an upper surface of the cover.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Locke in view of Cunningham and Holm.
Regarding claim 19, Locke teaches a negative pressure dressing (system 102 and dressing 124 in Fig. 1; Abstract) having a manifold (absorbent layer 184) and a cover disposed over the manifold (sealing member 140), wherein the manifold comprises a tissue-facing surface (bottom of absorbent layer 184; anti-microbial layer 190 and wicking layer 176 may also be interpreted as a bottom surface of the manifold) and an outward-facing surface (top of absorbent layer 184), the cover is disposed over the outward-facing surface of the manifold (Fig. 1 shows the sealing member 140 lying over the outward-facing surface of absorbent layer 184), the cover comprising a flange in proximity to the tissue-facing surface of the manifold (periphery 164).
Locke does not explicitly teach a skeleton support structure and holding the dressing by a portion of the skeleton support structure extends over the manifold, the skeleton support structure removably coupled to the cover.
Cunningham teaches a skeleton support layer for medical appliances (Fig. 1; Abstract), which is removable (Col. 4, lines 41-42), wherein the skeleton support layer comprises a base portion (side members 21 and 23), and a projection portion that extends over the device (cross and brace members 14 and 15) wherein the projection portion does not form a seal over the dressing (there are openings between the members, such as cavity 25 or opening 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support layer of Cunningham. Doing so would thus comprise a skeleton support layer comprising a (projection) portion, the (projection) portion configured to extend over the manifold and wherein the projection does not form a seal over the dressing. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination of Locke and Cunningham still do not explicitly teach the skeleton support structure coupled to the wound dressing and applying the dressing to a tissue site by said skeleton support structure to handle the dressing, wherein the skeleton support structure supports the dressing to prevent the cover from folding over during handling.
Holm teaches a wound dressing delivery system (Figs. 1A and 6A; Abstract), thus being in the same field of endeavor, comprising a support structure (carrier 14 and 114) which is removably coupled to an outer surface of a cover flange (backing 116) by an adhesive to provide a reversible connection (¶s 25-27 and 35-38 describes how a low strength adhesive is sandwiched between the backing 16 and the carrier 14), where said support structure is used to apply the dressing to a tissue site using the support structure to handle the dressing (Figs. 6A-B), wherein the support structure supports the dressing to prevent the cover from folding over during handling (¶s 5, 28, and 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of Locke and Cunningham to be able to use the skeleton support structure coupled to the wound dressing and applying the dressing to a tissue site by said skeleton support structure to handle the dressing, wherein the skeleton support structure supports the dressing to prevent the cover from folding over during handling. Doing so would be advantageous to prevent the cover from folding over during handling (¶s five, 28, and 53 of Holm).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Locke, Cunningham, and Holm teaches all the claimed structure, and further teaches using the support structure to handle the dressing. Thus, the combination would be expected to require applying the dressing to a tissue site using said skeleton support to handle the dressing, wherein the skeleton support structure supports the dressing to prevent the cover from falling over during handling; shaping and adhering the dressing to the tissue site to form a seal for negative pressure therapy; and removing the skeleton support structure from the dressing while leaving the dressing adhered to the tissue site.
Regarding claim 20, Holm further teaches that the cover may be removed after the dressing has been adhered to the tissue site (¶ 6 and 22).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and method of Locke and Cunningham to be able to use the skeleton support structure coupled to the wound dressing and applying the dressing to a tissue site by said skeleton support structure to handle the dressing, wherein the skeleton support structure supports the dressing to prevent the cover from folding over during handling. Doing so would be advantageous to prevent the cover from folding over during handling (¶s five, 28, and 53 of Holm).
Regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). As such, the combination of Locke, Cunningham, and Holm teaches all the claimed structure, and further teaches the support structure being removable. Thus, the combination would be expected to be removed after the dressing has been adhered to the tissue site (such as during replacement procedures) and wherein the seal of the dressing to the tissue remains intact after the skeleton support structure is removed.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Locke in view of Cunningham, and Wonder, as applied to claim 4 above, and further in view of Holm.
Regarding claim 21, Wonder further teaches that the support layer is removably coupled to the outer surface of the cover (support members 28 and 26; Col. 4, lines 17-44).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to an outer surface of the flange as taught by Wonder. Doing so would thus comprise the support layer being removably coupled to the outer surface of the cover. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
The combination of Locke, Cunningham, and Wonder do not explicitly teach said coupling being by an adhesive.
Holm teaches a wound dressing delivery system (Figs. 1A and 6A; Abstract), thus being in the same field of endeavor, comprising a support structure (carrier 14 and 114) which is removably coupled to an outer surface of a cover flange (backing 116) by an adhesive to provide a reversible connection (¶s 25-27 and 35-38 describes how a low strength adhesive is sandwiched between the backing 16 and the carrier 14).
Thus, Holm shows that an adhesive is an equivalent structure known in the art. Therefore, because these two temporary securing means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the adhesive of Holm with the mechanical interfering arrangement of Locke, Cunningham, and Wonder.
Claims 18 and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham and Wonder, as applied to claim 4 above, and further in view of Hammond (US 2018/0161212 A1).
Regarding claim 18, the combination of Locke, Cunningham, and Wonder do not explicitly teach the skeleton support structure comprises one or more thin molded components formed from polypropylene, ABS, or PETG having a thickness of about 0.02-0.200 inch.
Hammond teaches a protective covering comprising a wound dressing (Figs. 1-2 and 7,
particularly cover 32 and conventional dressing 50; Abstract), thus being in the same field of
endeavor, the support structure being made of steel or polypropylene (¶ 212).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the device of Locke, Cunningham, and Wonder out polypropylene because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art skeletal medical protection structures. Modifying Locke, Cunningham, and Wonder to comprise polypropylene would not change the devise function of providing a protective frame. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the device of Locke, Cunningham, and Wonder to comprise polypropylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
The combination of Locke, Cunningham, Wonder, and Hammond do not explicitly the support structure being thin molded and having a thickness of 0.020-0.200 inch.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Locke, Cunningham, Wonder, and Hammond to have a diameter of thickness of 0.020-0.200 inch since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Locke, Cunningham, and Wonder would not operate differently with the claimed skeleton thickness. Further, applicant places no criticality on the range claimed (¶ 100 of Applicant specification indicates the claimed ranges only in “some embodiments”).
Additionally, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Also see MPEP 2113. In the instant case, the “thin molding” process would only appear to produce a certain thickness of material, which is obvious as stated above.
Regarding claim 45, Wonder further teaches the skeleton support structure is substantially planar (support members 26 and 28 impart a planar structure) that is coupled to the outer surface of the flange (as seen in Figs. 2-4; also see Abstract and Col. 2, lines 19-23).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to an outer surface of the flange as taught by Wonder. Doing so also comprise the flange being self-supporting. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
Regarding claim 46, Wonder further teaches the lateral cage members may be removed, thus leaving behind the flange and support structure elements, which do not extend over the wound (as seen in Figs. 2-4; also see Abstract and Col. 2, lines 19-23).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke and Cunningham to couple the skeleton support structure to an outer surface of the flange as taught by Wonder. Doing so would thus comprise the skeleton support extending around, but not extending over the manifold. Doing so would be advantageous in providing an adjustable and reversible connection (Col. 4, line 64 – Col. 5, line 25).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, and Wonder, as applied to claim 6 above, and further in view of Holm.
Regarding claim 10, the combination of Locke, Cunningham, and Wonder substantially disclose the invention of claim 6. They do not explicitly teach the skeleton support structure being removably coupled to the outer surface of the flange by a low-tack adhesive.
Holm teaches a wound dressing delivery system (Figs. 1A and 6A; Abstract), thus being in the same field of endeavor, comprising a support structure (carrier 14 and 114) which is removably coupled to an outer surface of a cover flange (backing 116) by a low-tack adhesive to provide a reversible connection (¶s 25-27 and 35-38 describes how a low strength adhesive is sandwiched between the backing 16 and the carrier 14).
Thus, Holm shows that a low-tack adhesive is an equivalent structure known in the art. Therefore, because these two temporary securing means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the adhesive of Holm with the mechanical interfering arrangement of Locke, Cunningham, and Wonder.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, Wonder, and Holm, as applied to claim 10 above, and further in view of Spier.
Regarding claim 28, Locke further teaches an adhesive attachment device configured to couple the dressing to a tissue site for negative-pressure treatment (adhesive 136; ¶s 35-36).
Spier teaches a protective covering comprising a wound dressing (Figs. 1-2 and 7,
particularly cover 32 and conventional dressing 50; Abstract), thus being in the same field of
endeavor, comprising a support structure (cover 32) removably coupled to an outer surface of a
flange (frame 10; Col. 6, lines 43-47); wherein the support structure extends from the outer surface of the flange over the dressing (best seen in Fig. 7), and wherein the removal force for the support is less than an attachment device configured to couple the dressing to the tissue site (Col. 1, lines 58-63 and Col. 3, lines 3-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Locke, Cunningham, Wonder, and Holm such that the low-tack adhesive coupling the skeleton support structure to the outer surface of the flange has a lower adhesion strength in the adhesive attachment device for the dressing, as taught by Spier. Doing so would be advantageous in preventing irritation and excessive forces on the body (Col. 1, lines 58-63 and Col. 3, lines 3-16 of Spier).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, Wonder, and Holm, as applied to claim 10 above, and further in view of Knutson (US 2014/0303574 A1).
Regarding claim 29, the combination of Locke, Cunningham, Wonder, and Holm substantially disclose the invention of claim 10. They do not explicitly teach the low-tack adhesive has an adhesion strength of about 0.2 N-16.1 N.
However, Knutson teaches an adhesive patch for wound protection (Figs. 1-3; Abstract and ¶ 2), thus being in the same field of endeavor, which utilizes a weak adhesive having a peel strength of less than 50g (¶ 36 defines the term “does not adhere well”, 50g of force is equivalent to approximately 0.5 N).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adhesive of Locke, Cunningham, Wonder, and Holm to be 0.5 N or less. Doing so would be advantageous in retaining removability of the skeleton support structure (¶ 35 of Knutson describes how the 0.5 N or less range provides good release characteristics).
The combination does not explicitly disclose the range of 0.2 N to 16.1 N. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of 0.5 N or less to be 0.2 N to 16.1 N as Applicant appears to have placed no criticality on the claimed range (¶ 96 of Applicant specification recite the low-tack adhesive as “an example” and that the claimed range is only in “some embodiments”.) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 12 and 33-34 rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, and Wonder, as applied to claim 6 above, and further in view of Hammond.
Regarding claim 12, the combination of Locke, Cunningham, and Wonder substantially disclose the invention of claim 6.
Cunningham further teaches a longitudinal support (brace members 15) and lateral supports substantially spanning the width of the cover (cross members 14).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise a skeleton support structure comprising longitudinal and lateral supports extending from the longitudinal support. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination does not explicitly teach the skeleton support structure comprises the longitudinal support and two lateral supports each extending from the longitudinal support to substantially a perimeter of the flange; each of the two lateral supports extends from the longitudinal support in proximity to one of two ends of the longitudinal support; and the two lateral supports each substantially span a width of the cover.
Hammond teaches a wound dressing closure device (Fig. 1; Abstract) comprising a skeleton support structure (support member 102) which comprise: a longitudinal support (top portion 116 and shaft 122) and two lateral supports each extending from the longitudinal support to substantially a perimeter of the wound cover (legs 114) that can be rotated relative to the longitudinal support (¶s 9 and 214).
Thus, the manner of enhancing a particular device (skeletal wound frames) would have been with an ordinary skill in the art in view of the teachings of Hammond. One of ordinary skill in the art would have been capable of applying this known improvement technique in the same manner to the prior art skeletal frame of a combination of Locke, Cunningham, and Wonder. See MPEP 2143. The result would have been predictable in that one of ordinary skill in the art would have recognized that rotatable lateral supports relative to a longitudinal support in the combination would advantageously allow for adjustment to accommodate a wide range of wound sizes and shapes (¶s 9 and 214 of Hammond).
Regarding claim 33, the combination of Locke, Cunningham, Wonder, and Hammond substantially disclose the invention of claim 12.
Hammond further teaches the two lateral supports each extend for opposite sides of the longitudinal support to substantially span the width of the wound dressing cover (shown in Fig. 1, legs 114 substantially span cover 106).
As previously stated, Hammond shows that skeleton support structure formed of a longitudinal support and two lateral support struts extending from the longitudinal support is an equivalent structure known in the art, including the two lateral supports each extending from opposite sides of the longitudinal support to substantially span the width of the wound cover. Therefore, because these skeletal support arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the support arrangement of Hammond with the arrangement of Locke, Spier, and Wonder.
Regarding claim 34, the combination of Locke, Cunningham, Wonder, and Hammond substantially disclose the invention of claim 12.
Hammond further teaches the support structure comprises one or more intermediate lateral supports, space between the two ends of the longitudinal support (multiple rows of legs 114, such as those extending from portion 116f or 116c would serve as intermediate lateral supports).
As previously stated, Hammond shows that skeleton support structure formed of a longitudinal support and two lateral support struts extending from the longitudinal support is an equivalent structure known in the art, including the two lateral supports each extending from opposite sides of the longitudinal support to substantially span the width of the wound cover. Therefore, because these skeletal support arrangements were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the support arrangement of Hammond with the arrangement of Locke, Spier, and Wonder.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, and Wonder, as applied to claim 9 above, and further in view of Hammond.
Regarding claim 13, the combination of Locke, Cunningham, and Wonder substantially disclose the invention of claim 9.
Cunningham further teaches a longitudinal support (brace members 15a/c) and two lateral supports each extending from the longitudinal support to a perimeter of the device (cross members 14), the base portion comprises a perimeter support (side members 21/23); the lateral supports couple to the base portion of the longitudinal support (Col. 3, lines 18-22 indicate welding) and the projection portion comprises the longitudinal support (brace members 15 are interpreted as being part of the projection portion).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise a skeleton support structure comprising longitudinal and lateral supports extending from the longitudinal support. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination does not explicitly teach the skeleton support structure comprises the two lateral supports each extending from the longitudinal support to substantially a perimeter of the flange.
Hammond teaches a wound dressing closure device (Fig. 1; Abstract) comprising a skeleton support structure (support member 102) which comprise: a longitudinal support (top portion 116 and shaft 122) and lateral supports each extending from the longitudinal support to substantially a perimeter of the, which connect the longitudinal support to the dressing (legs 114) that can be rotated relative to the longitudinal support (¶s 9 and 214).
Thus, the manner of enhancing a particular device (skeletal wound frames) would have been with an ordinary skill in the art in view of the teachings of Hammond. One of ordinary skill in the art would have been capable of applying this known improvement technique in the same manner to the prior art skeletal frame of a combination of Locke, Cunningham, and Wonder. See MPEP 2143. The result would have been predictable in that one of ordinary skill in the art would have recognized that rotatable lateral supports relative to a longitudinal support in the combination would advantageously allow for adjustment to accommodate a wide range of wound sizes and shapes (¶s 9 and 214 of Hammond).
Regarding claim 14, the combination of Locke, Cunningham, and Wonder substantially disclose the invention of claim 9.
Cunningham further teaches a longitudinal support (brace members 15a/c) and two lateral supports each extending from the longitudinal support to a perimeter of the device (cross members 14), the base portion (side members 21/23) comprises portions of the lateral supports (Col. 3, lines 18-22 indicate welding between supports) and the projection portion comprises portions of the longitudinal support (brace members 15 are interpreted as being part of the projection portion).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke to comprise the skeleton support structure of Cunningham. Doing so would thus comprise a skeleton support structure comprising longitudinal and lateral supports extending from the longitudinal support. Doing so would be advantageous in protecting the dressing and user during activities such as sports (Col. 2, lines 23-38 and Col. 2, lines 1-13).
The combination does not explicitly teach the skeleton support structure comprises the two lateral supports each extending from the longitudinal support to substantially a perimeter of the flange.
Hammond teaches a wound dressing closure device (Fig. 1; Abstract) comprising a skeleton support structure (support member 102) which comprise: a longitudinal support (top portion 116 and shaft 122) and lateral supports each extending from the longitudinal support to substantially a perimeter of the, which connect the longitudinal support to the dressing (legs 114) that can be rotated relative to the longitudinal support (¶s 9 and 214).
Thus, the manner of enhancing a particular device (skeletal wound frames) would have been with an ordinary skill in the art in view of the teachings of Hammond. One of ordinary skill in the art would have been capable of applying this known improvement technique in the same manner to the prior art skeletal frame of a combination of Locke, Cunningham, and Wonder. See MPEP 2143. The result would have been predictable in that one of ordinary skill in the art would have recognized that rotatable lateral supports relative to a longitudinal support in the combination would advantageously allow for adjustment to accommodate a wide range of wound sizes and shapes (¶s 9 and 214 of Hammond).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, and Wonder, as applied to claim 11 above, and further in view of Doshi et al. (US 2019/0328581 A1).
Regarding claim 16, the combination of Locke, Cunningham, and Wonder substantially disclose the invention of claim 11.
However, the combination does not explicitly disclose the skeleton support structure has a Young’s Modulus of 1-10 GPa as required by the claim.
Doshi teaches a wound dressing support device (Figs. 4I, 4L, and 5-6; Abstract), thus being in the same field of endeavor, which comprises a rigid or semi-rigid frame structure of greater than 0.4 GPa (¶s 11 and 39) and also that the device may be made more flexible or more rigid in order to either better conform to the shape of a wound or to better support a seal for negative pressure (¶ 197).
Thus, Young’s Modulus is disclosed to be a result effective variable in that Young’s Modulus (i.e. rigidity) affects properties of the wound dressing such as the ability to conform to the wound, and ability to seal for negative pressure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Locke, Cunningham, and Wonder as a matter of routine optimization 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, applicant places no criticality on the range claimed (¶ 93 of Applicant specification indicates the claimed ranges only in “some embodiments”).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, Wonder, and Hammond, as applied to claim 12 above, and further in view of Östan et al. (US 2017/0367898 A1).
Regarding claim 38, the combination of Locke, Cunningham, Wonder, and Hammond substantially disclose the invention of claim 12. They do not explicitly teach the dressing comprises one or more wing portions extending laterally away from a longitudinal centerline of the dressing, and for each wing portion, a lateral support spans the wing portion to couple the longitudinal support to the flange at a perimeter of the wing portion.
Östan teaches a medical wound dressing (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a series of wing portions (wings 36 and 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dressing and corresponding support of Locke, Cunningham, Wonder, and Hammond, as taught by Östan. Doing so would be advantageous in fitting the wound to certain body anatomies (¶ 50 of Östan).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, in view of Cunningham, and Wonder, as applied to claim 5 above, and further in view of Hammond.
Regarding claim 43, the combination of Locke, Cunningham, and Wonder substantially disclose the invention of claim 5.
The combination does not explicitly teach the skeleton support structure is peaked, with two triangle vertices extending from the flange and one triangle for text located above the manifold.
Hammond teaches a wound dressing closure device (Fig. 1; Abstract) comprising a skeleton support structure (support member 102) which comprise: a longitudinal support (top portion 116 and shaft 122) and two lateral supports (legs 114) that can be rotated relative to the longitudinal support (¶s 9 and 214). The supports forming a peaked structure with two triangle vertices extending from the cover and one triangle for text located above the manifold (Fig. 1 shows a series of vertices, such as in sections 116a, 116d, and 116h; Fig. 3 shows how the vertex is above the manifold 112).
Thus, the manner of enhancing a particular device (skeletal wound frames) would have been with an ordinary skill in the art in view of the teachings of Hammond. One of ordinary skill in the art would have been capable of applying this known improvement technique in the same manner to the prior art skeletal frame of a combination of Locke, Cunningham, and Wonder. See MPEP 2143. The result would have been predictable in that one of ordinary skill in the art would have recognized that rotatable lateral supports relative to a longitudinal support in the combination would advantageously allow for adjustment to accommodate a wide range of wound sizes and shapes (¶s 9 and 214 of Hammond). Doing so would thus comprise two triangle vertices extending from the flange (i.e. the flange of Wonder) and one triangle vertex located above the manifold.
Conclusion
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781