DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, 4-6, 11-14, 21-22, 27, and 28-33 are currently pending. Claims 2, 7-8, 10, 15, 17-20, and 23-24 remain cancelled. Claims 3, 9, 16, and 25-26 are newly cancelled. Claims 28-33 have been newly added. Claims 1, 12, 14, 21, and 27 have been amended. All previously presented 112 rejections have been overcome.
Response to Arguments
Applicant's arguments filed April 23rd, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the newly amended claims have been considered but are not persuasive as applicant has argued that Rapp does not anticipate the newly amended claims in that Rapp does not disclose a sacrificial porogen that is a protein, a polysaccharide, or a polymer, however, the examiner disagrees in that Rapp discloses providing a collagen component that would inherently provide the structure required to function as a sacrificial porogen when in contact with the wound and as such this claim limitation is anticipated by Rapp (see below rejection of claim 1). Applicant has stated that the Office action acknowledges that Rapp does not teach or suggest such features, the office action had stated that Rapp did not expressly disclose a sacrificial porogen and has again stated that this express disclosure is not present, however, the term sacrificial porogen is considered to simply describe a function of an element and when the structure of that element is greater defined such as in the case of the protein collagen as described by the applicant’s specification, Rapp is seen to provide the structure of this element through the presence of collagen (see below rejection of claim 1). Phillip was initially relied upon for its teaching of a gaseous sacrificial porogen and as such the scope of the claim has changed and thus the rejection presented.
Regarding the argument that Rapp also does not disclose a bioactive protein that is fibrinogen, Factor XII, a growth factor, or a combination, examiner also disagrees in that Rapp states that growth factors such as insulin-like growth factor which is a known protein can be included in the composition and thus this limitation is seen to be disclosed by Rapp. As such the rejection of claim 21 in light of Rapp in view of Hartwell is herein maintained by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rapp (U.S. Publication 2017/0290708).
Regarding claim 1, Rapp discloses a wound treatment system (Fig. 11) comprising: a foam dressing (see illustrative diagram of Fig. 12 below) configured for application to and for lining or filling a wound cavity (¶0067 applied through injection port);
said foam dressing comprising a foam mixture of a first component and a second component (¶0041, multi-component liquid form, see syringe in figure 11) wherein said second component comprises a curing agent (¶0040 catalyst);
wherein said foam mixture is configured for curing within said wound cavity (¶0041 injected into wound of interest and allowed to react to create custom negative pressure therapy sponge);
and wherein said foam dressing is configured for compacting and for accommodating transfer of fluid (¶0047 compressible, allow for fluid exudate removal) from said wound out of said wound under a pressure gradient (¶0047 under negative pressure);
wherein said foam dressing further comprises a third component, wherein said third component comprises a protein (¶0050 collagens may be added to 2-part silicone preparation);
a semi-permeable membrane (see illustrative diagram of Fig. 12 below, ¶0063 film may have semi-permeable membranes) covering said foam mixture;
an inlet port (see illustrative diagram of Fig. 12 below, irrigation port) connected to said membrane and a fluid source (connects to syringe which is source of fluid, ¶0068 irrigation port as a conduit for delivering medications/therapies antibiotic irrigation), said inlet port configured for delivering soluble bioactive factors (delivers sponge from syringe, ¶0050 growth factor families added to 2-part silicone preparation to improve wound healing capacity) to said wound via said inlet port; and
an outlet port (see illustrative diagram of Fig. 12 below) connected to said membrane and a suction device (¶0068 adapter and associated suction house attached to suction port to permit subsequent application of negative pressure), said outlet port configured for discharging exudate from said wound via said outlet port (¶0047 fluid exudate removal occurs through negative pressure and therefore through outlet port).
Rapp does not expressly disclose the protein being a sacrificial porogen, however, the limitation of “sacrificial porogen” is considered functional language (based on Paragraph 0028 and 0050 of Applicant' s specification indicating this term is used to denote a substance that “can alter the porous fraction of the final wound liner and/or foam inserts” ¶0028 or “a sacrificial component” ¶0050) as the term sacrificial porogen is not a description of the structure of element but rather describes the function of the element to be sacrificed such that a pore is formed once that element has been removed. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Rapp discloses all the structure as claimed as it discloses including collagen, which is denoted by the applicant as being a sacrificial porogen (¶0052). As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a sacrificial porogen).
Regarding claim 4, Rapp discloses the wound treatment system according to claim 1. Rapp further discloses said foam dressing comprises an open-cell foam (¶0041 open cell pores).
Regarding claim 5, Rapp discloses the wound treatment system according to claim 1. Rapp further discloses a foam wound liner (portion of foam dressing in contact with the wound) configured for lining a wound bed (base of wound defining wound cavity) and a foam wound filler (portion of foam dressing not in contact with the wound that fills the wound cavity) spread (¶0038 expand) in said liner.
Regarding claim 6, Rapp discloses the wound treatment system according to claim 1. Rapp further discloses inclusion of a hydrogel (¶0051 enzymatic debriding products added to 2-part system including hydrogels).
Regarding claim 12, Rapp discloses the wound treatment system according to claim 1. Rapp further discloses the third component being a wound liner (¶0067 foam applied through the injection port into the wound, foam components react and expand to form custom negative pressure therapy sponge that conforms to and fills the wound, thus all three components make up a foam that lines the wound and thus is a wound liner) and comprises a liner bioactive agent (¶0050 growth factors added to 2-part silicone preparation and thus part of wound liner).
Regarding claim 13, Rapp discloses the wound treatment system according to claim 12. Rapp does not expressly disclose the liner bioactive agent being configured for release from said wound liner into said wound cavity, however, the limitation of “configured for release from said wound liner into said wound cavity” is considered functional language (describes ability of agent to disassociate with wound liner). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Rapp discloses all the structure as claimed and further discloses the growth factors being capable of modifying the wound to improve wound healing capacity ¶0050 as well as the structure of the foam wound liner being open celled (¶0041 open cell pores) which would inherently allow exposure of the included growth factors to the wound cavity and thus allow for the release of this component into the wound cavity upon reaction with the surrounding wound environment. As such, it is capable of performing the functions as claimed (i.e. it is capable of release from said wound liner into said wound cavity).
Regarding claim 14, Rapp discloses the wound treatment system according to claim 1. Rapp further discloses the third component being a wound liner (¶0067 foam applied through the injection port into the wound, foam components react and expand to form custom negative pressure therapy sponge that conforms to and fills the wound, thus all three components make up a foam that lines the wound and thus is a wound liner) and thus the third component comprises a liner sacrificial porogen; and a forth component that comprises a liner bioactive agent (¶0050 growth factors added to 2-part silicone preparation and thus part of wound liner).
Regarding claim 29, Rapp discloses the wound treatment system according to claim 1. Rapp further discloses the sacrificial porogen being collagen (¶0050 collagens may be added to 2-part silicone preparation).
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 11, 21-22, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Rapp (U.S. Publication 2017/0290708) in view of Hartwell et al. (U.S. Publication 2017/0007462).
Regarding claim 11, Rapp discloses the wound treatment system according to claim 5. Rapp further discloses the pore size and bulk porosity (¶0043 pores per inch) variables of said foam effecting compressibility of foam inserts (¶0047 pore size employed selected base on amount of microdeformation desired, ¶0019 balance of sponge compression to ability of a sponge to promote mechanical creep, pore sized between 400-600 better prevents the accumulation of large amounts of granulation tissue) ; and compressibility of foam effecting degrees of physiochemical and mechanotransduction (¶0019 mechanical creep of surrounding tissue, sponge compression) response of damaged tissue in said wound sites.
Rapp does not expressly disclose a foam insert embedded in said foam filler.
However, Hartwell, in the same field of endeavor of wound dressings for use with negative pressure devices, teaches embedding a foam (¶0154 felted foam) insert 1100 embedded in a foam filler (¶0152 porous foam may be fabricated to encapsulate the stabilizing structure 1100) for the purpose of adding a stabilized structure that is substantially rigid and resists collapse in the vertical direction once negative pressure is applied while still maintaining a porous nature to permit negative pressure to be transmitted to the wound and for wound exudate to be removed.
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 negative pressure dressing of Rapp to have included a foam insert embedded in the foam filler as taught by Hartwell for the purpose of adding a stabilized structure that is substantially rigid and resists collapse in the vertical direction once negative pressure is applied while still maintaining a porous nature to permit negative pressure to be transmitted to the wound and for wound exudate to be removed.
Regarding claim 21, Rapp discloses a wound treatment system (Fig. 11) comprising:
a foam dressing (see illustrative diagram of Fig. 12 below) comprising:
a foam wound liner (portion of foam dressing in contact with the wound) comprising a bioactive protein (¶0050 insulin-like growth factor may be added to 2-poart preparation to improve wound healing), wherein the bioactive protein is a growth factor (¶0050 insulin-like growth factor) said foam wound liner configured for lining a wound bed (base of wound defining wound cavity) and capable of augmenting wound healing (¶0051 accelerate healing);
a foam wound filler (portion of foam dressing not in contact with the wound that fills the wound cavity) spread (¶0038 expand) in said liner
a semi-permeable membrane (see illustrative diagram of Fig. 12 below, ¶0063 film may have semi-permeable membranes) covering said foam mixture;
an inlet port (see illustrative diagram of Fig. 12 below, irrigation port) connected to said semi-permeable membrane, wherein said inlet port is connectable to a fluid source (connects to syringe which is source of fluid, ¶0068 irrigation port as a conduit for delivering medications/therapies antibiotic irrigation) and configured for fluid delivery (syringe delivers fluid to wound cavity); and
an outlet port (see illustrative diagram of Fig. 12 below) connected to said semi-permeable membrane, wherein said outlet port is connectable to a suction source (¶0068 adapter and associated suction house attached to suction port to permit subsequent application of negative pressure) and configured for discharging exudate.
Rapp does not expressly disclose said foam wound liner and said foam wound filler comprising foam materials with different pore configurations; wherein said foam wound liner comprises small, non-enmeshing pores and said foam wound filler comprises large pores.
However, Hartwell, in the same field of endeavor of wound dressings for use with negative pressure devices, teaches a foam dressing 203 having a foam wound filler 226 and foam wound liner (222 and 224) with different cellular and pore configurations (¶0076, wound filler 226 greater porosity or larger pores than the wound contacting surfaces 222 and 224) for the purpose of enhancing fluid removal through the dressing as the larger pores are not in contact with the wound and therefore granulation tissue from the wound will not grow into the larger pores ¶0076.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the foam wound liner and the foam wound filler discloses by Rapp to comprise foam materials with different cellular and pore configurations, as taught by Hartwell, for the purpose of enhancing fluid removal through the dressing as the larger pores are not in contact with the wound and therefore granulation tissue from the wound will not grow into the larger pores ¶0076.
Regarding claim 22, Rapp in view of Hartwell suggest the wound treatment system according to claim 21. Rapp further discloses said foam wound filler being open-celled (¶0041 open cell pores), reticular (¶0040 reticulated).
Regarding claim 25, Rapp in view of Hartwell suggest the wound treatment system according to claim 21. Rapp further discloses the bioactive protein being an enzyme (¶0051 enzymatic, collagenase, elastase, myeloperoxidase etc.).
Regarding claim 27, Rapp in view of Hartwell suggest the wound treatment system according to claim 21. Rapp further discloses a method of treating a wound with the wound treatment system, the method comprising the steps of:
Applying the foam wound liner in the wound cavity (¶0038 injected into wound);
Spreading the foam wound filler into said foam wound liner (¶0038 expands thus filler spreads out into the liner portion);
Covering the foam filler with a semi-permeable membrane (¶0063 placed over exemplary negative pressure therapy sponge);
Connecting the semi-permeable membrane to a suction source via the at least one outlet port (¶0068 suction hosing attached to suction port);
Delivering a solution comprising a growth factor (¶0050 2-part silicone preparation containing insulin-like growth factor) to said wound via said inlet port (delivered through inlet port, see fig. 11); and
Discharging exudate from said wound via said outlet port (¶0047 fluid exudate removal occurs through negative pressure and therefore through outlet port).
Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rapp (U.S. Publication 2017/0290708) in view of Guelcher et al. (U.S. Publication 2013/0295081).
Regarding claim 30, Rapp discloses the wound treatment system according to claim 1. Rapp does not expressly disclose the sacrificial porogen being a polysaccharide selected from the group consisting of dextran, xanthan gum, pectin, hyaluronic acid, carrageenan, guar gum, and cellulose.
However, Guelcher, in the same field of endeavor of injectable porous composites for treating wounds (Abstract), teaches utilizing a polysaccharide porogen consisting of dextran (¶0031 porogens typically water soluble such as polysaccharides dextran) within the injectable composite for the purpose of providing latent porosity after injection ¶0031, as well as decreasing bleeding at or near the site of use (¶0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included dextran in the injectable porous composite, as taught by Guelcher, for the purpose of providing latent porosity after injection (¶0031 of Guelcher), as well as decreasing any potential bleeding at or near the site of use (¶0080).
Regarding claim 31, Rapp discloses the wound treatment system according to claim 1. Rapp does not expressly disclose the sacrificial porogen being a polymer selected from the group consisting of polyethylene oxide, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, polyacrylamides, polyphosphate, and hydroxypropyl methacrylamide.
However, Guelcher, in the same field of endeavor of injectable porous composites for treating wounds (Abstract), teaches utilizing a polymer consisting of polyethylene glycol (¶0031 Porogens can be natural or synthetic polymers, exemplary polymers include polyethylene glycol) for the purpose of providing latent porosity after injection (¶0031 of Guelcher).
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 composition of Rapp to have included a sacrificial porogen of polyethylene glycol for the purpose of providing latent porosity after injection (¶0031 of Guelcher).
Regarding claim 32, Rapp discloses the wound treatment system according to claim 1. Rapp does not expressly disclose the sacrificial porogen being polyethylene glycol or gelatin.
However, Guelcher, in the same field of endeavor of injectable porous composites for treating wounds (Abstract), teaches utilizing polyethylene glycol (¶0031 Porogens can be natural or synthetic polymers, exemplary polymers include polyethylene glycol) as a porogen for the purpose of providing latent porosity after injection (¶0031 of Guelcher).
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 composition of Rapp to have included a sacrificial porogen of polyethylene glycol for the purpose of providing latent porosity after injection (¶0031 of Guelcher).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Rapp (U.S. Publication 2017/0290708) in view of Hartwell et al. (U.S. Publication 2017/0007462) in view of Phillips (U.S. Publication 2013/0310780).
Regarding claim 28, Rapp in view of Hartwell suggest the wound treatment system of claim 21. Rapp in view of Hartwell do not expressly disclose or suggest the bioactive protein comprising fibrinogen or Factor XIII.
However, Phillips, in the same field of endeavor of multi-component dressings curable in-situ, teaches providing fibrinogen (¶0153 fibrinogen) for the purpose of providing the dressing with a hemostatic agent (¶0152 composition may comprise active agents, suitable active agents include hemostats; ¶0153 hemostats may be selected from fibrinogen).
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 composition of Rapp to have included fibrinogen in order to provide a hemostatic agent that would have had the benefit of aiding in the cessation of bleeding by enhancing coagulation which is the known effect of hemostats.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Rapp (U.S. Publication 2017/0290708) in view of Guelcher et al. (U.S. Publication 2013/0295081) and in view of Phillips (U.S. Publication 2013/0310780).
Regarding claim 33, Rapp discloses the wound treatment system according to claim 12. Rapp does not expressly disclose the sacrificial porogen being polyethylene glycol or gelatin and wherein the liner bioactive agent is a protein selected from the group consisting of fibrinogen, Factor XIII, or a combination thereof.
Regarding the sacrificial porogen, Guelcher, in the same field of endeavor of injectable porous composites for treating wounds (Abstract), teaches utilizing polyethylene glycol (¶0031 Porogens can be natural or synthetic polymers, exemplary polymers include polyethylene glycol) as a porogen for the purpose of providing latent porosity after injection (¶0031 of Guelcher).
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 composition of Rapp to have included a sacrificial porogen of polyethylene glycol for the purpose of providing latent porosity after injection (¶0031 of Guelcher).
Regarding the liner bioactive agent, Phillips, in the same field of endeavor of multi-component dressings curable in-situ, teaches providing fibrinogen (¶0153 fibrinogen) for the purpose of providing the dressing with a hemostatic agent (¶0152 composition may comprise active agents, suitable active agents include hemostats; ¶0153 hemostats may be selected from fibrinogen).
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 composition of Rapp to have included fibrinogen, and thus a liner bioactive agent including fibrinogen, in order to provide a hemostatic agent that would have had the benefit of aiding in the cessation of bleeding by enhancing coagulation which is the known effect of hemostats.
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 PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781