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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 10th, 2026 has been entered.
Claim Status
Claims 21-22 and 27are currently pending. Claims 1-20, 23-26, and 28-33 are cancelled. Claims 28-33 have been newly added. Claim 21 has been amended.
Response to Arguments
Applicant's arguments filed June 10th, 2026 have been fully considered but they are not persuasive.
While examiner agrees that the amendment to the claim limitations has overcome the rejection of record presented in the Final Rejection mailed on December 10th, 2026. In light of the teachings of Ericson (U.S. Publication 2013/0202674) these limitations are seen to have been obvious to one of ordinary skill in the art as detailed in the below rejection.
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 21-22 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Rapp (U.S. Publication 2017/0290708) in view of Ericson (U.S. Publication 2013/0202674) and Hartwell et al. (U.S. Publication 2017/0007462).
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 comprising fibrinogen or factor XIII, or 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, Ericson, in the same field of endeavor of wound treatment, teaches utilizing fibrinogen, factor XIII, and a growth factor (¶0004 2-vial system containing fibrinogen, thrombin, factor XIII, and calcium) to line a wound (¶0004 applied onto a dry tissue bed) for the purpose of preventing excess blood loss through the hemostatic nature of this combination as thrombin converts fibrinogen into fibrin and activates factor XIII, which stabilizes the clot, by promoting polymerization and/or cross-linking of the fibrin chains (¶0003).
As such 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 foam wound liner to have included the hemostatic agent comprising the combination of fibrinogen, coagulation factor XIII, and the growth factor thrombin, as taught by Ericson for the purpose of preventing excess blood loss through the hemostatic nature of this combination as thrombin converts fibrinogen into fibrin and activates factor XIII, which stabilizes the clot, by promoting polymerization and/or cross-linking of the fibrin chains (¶0003).
Regarding the wound liner and wound filler comprising foam materials with different pore configuration, 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 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).
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.
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 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
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