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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed on 10/13/2025, with respect to the rejection(s) of independent claim 1 and its dependents under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Heagle et al. (Publication No. US 2013/0204213 A1). Heagle teaches a wound cover that is used with a negative pressure wound therapy system (wound dressing 100 and negative pressure wound therapy 24; Figure 1B and 8A-8B; Paragraph 0071) and is designed to release biocompatible polymers over time in its standoffs (active agents are in the fibers for release over time; Paragraph 0050-0052, where the fibers are filler material 252; Paragraph 0096; Figures 8A-8B; see rejection of claim 1 below). Accordingly, this action is a second Final Rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 15-17, 21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1).
Regarding claim 1, Heagle discloses a system for treating a tissue site (wound dressing 100 and negative pressure wound therapy 24; Figure 1B and 8A-8B; Paragraph 0071), comprising:
a tissue interface (packing structure 250; Figures 8A-8B; Paragraph 0096) comprising:
a first film (top sheet of contact material 254, see Paragraph 0096 – contact material is made of film, see Paragraph 0011; Figures 8A-8B),
a second film (bottom sheet of contact material 254, see Paragraph 0096 – contact material is made of film, see Paragraph 0011; Figures 8A-8B), the first film and the second film having inner surfaces coupled to each other in a pattern to seal the first film to the second film and form a single sheet (inner surfaces of top and bottom films of contact material 254 are sealed in a pattern and form a single sheet; Figures 8A-8B; Paragraph 0096),
a plurality of standoffs defined by the pattern and extending away from an outer surface of the sheet (pods 258, 260, and 262 are defined by a pattern and extend away from the outer surface of the sheet; Figures 8A-8B; Paragraph 0096-0097), the plurality of standoffs being separated from each other by space regions (pods 258, 260, and 262 are separated from each other by seals 268; Paragraph 0096-0097; Figures 8A-8B), wherein at least some of the standoffs enclose a composition comprising a biocompatible polymer and the standoffs are configured to release the biocompatible polymer over a selected time period (active agents are in the fibers for release over time; Paragraph 0050-0052, where the fibers are filler material 252; Paragraph 0096; Figures 8A-8B), and
a plurality of apertures extending through the tissue interface in the space regions between the standoffs (perforated rings 268 extend through the structure 250 in the seals 256 between the pods; Figures 8A; Paragraph 0096), the apertures configured to provide fluid communication across the tissue interface (obvious that perforations are apertures and are fully capable of providing fluid communication; Paragraph 0096);
a cover configured to be disposed adjacent to the tissue interface and to form a seal around the tissue site (cover 22 is adjacent to wound dressing 100; Figure 1B; Paragraph 0066); and
a negative-pressure source fluidly coupled to the tissue interface through the cover (negative pressure wound therapy source 50 is fluidly coupled to the dressing 100 through cover 22; Figure 1B; Paragraph 0075). The embodiment of Figures 8A-8B of Heagle does not teach the first film and the second film being non-porous, polymeric films.
However, another embodiment of Heagle teaches the films being formed of a porous or nonporous sheet of polypropylene (Paragraph 0103).
Since the prior art of Heagle recognizes a nonporous film sheet can be used as the contact film (Paragraph 0103) and is analogous to the claimed invention in the field of negative pressure wound therapy systems, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the first and second films of Heagle to be the nonporous polypropylene film sheets, as taught by Heagle, as it is merely the selection of functionally equivalent film materials, with the function of releasing agents and absorbing wound fluid, recognized in the art and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another, substituting the first and second films of Heagle with the nonporous polypropylene films of Heagle, is obvious when predictable results are achieved, with the results of separating desired blood components from the collected blood of the user. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, B.).
Regarding claim 4, Heagle teaches the system of claim 1. Heagle further teaches wherein the standoffs are cells having a closed end (pods 258, 260, and 262 are cells/structures with closed ends; Figures 8A-8B; Paragraph 0096).
Regarding claim 15, Heagle teaches the system of claim 1. Heagle further teaches wherein the biocompatible polymer comprises a biologically-active polymer (active agents can be a biologically-active polymer; Paragraph 0050-0052).
Regarding claim 16, Heagle teaches the system of claim 1. Heagle further teaches wherein the biocompatible polymer is bioresorbable (active agent can be a biodegradable biguanide, such as polyethylene hexamethylene biguanide – obvious that biodegradable polymer is bioresorbable; Paragraph 0052).
Regarding claim 17, Heagle teaches the system of claim 1. Heagle further teaches wherein the biocompatible polymer comprises anti-inflammatory, matrix metalloproteinases (MMP)-mitigating or antimicrobial polymers (Paragraph 0050-0052).
Regarding claim 21, Heagle teaches the system of claim 1. Heagle further teaches wherein the biocompatible polymer comprises hyaluronic acid, chitosan, heparin, alginate, cellulose, fibrin, gelatin, chondroitin sulfate, agarose, dextran, carrageenan, silk, poly(ethylene glycol), poly(vinyl alcohol),polycaprolactone, polyphophazene, polyglycolic acid, rosin, lactose, sucrose, tapioca starch, and polyvinylpyrrolidone, or any combination thereof (biocompatible polymers can be cellulose; Paragraph 0040-0041).
Regarding claim 26, Heagle teaches the system of claim 1. Heagle further teaches wherein at least some of the standoffs form protrusions on two sides of the tissue interface (Figures 9A-9F; Paragraph 0098-0101).
Claim 2, 25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 1 above, and further in view of Wada (Publication No. US 2015/0290050 A1).
Regarding claim 2, Heagle teaches the system of claim 1. Heagle does not teach wherein at least one of the first film and the second film comprise a fluid control layer having a surface adjacent to the plurality of standoffs, the surface being even and free from perceptible projections, lumps or indentations. The fluid control layer is interpreted to be the surface of film 515 facing the standoffs and connected to film 525, as depicted in Figures 5A-B and Paragraphs 0056-0065 of the instant application.
However, Wada teaches wherein at least one of the first film and the second film comprise a fluid control layer having a surface adjacent to the plurality of standoffs, the surface being even and free from perceptible projections, lumps or indentations (flat sheet material 4/fluid control layer has a surface that is adjacent to the sheet 2 and is free from projections and lumps – through hole 8 is not required; Paragraphs 0046-0054; Figures 4 and 5).
Heagle and Wada are both considered to be analogous to the claimed invention because they are in the same field of absorbent articles. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Wada and have the second film of Heagle/fluid control layer to be a flat sheet, as taught by Wada. This will allow for the flat area, made of the flat sheet, to be easily joined to another sheet for making absorbent articles (Wada; Paragraph 0048-0049).
Regarding claim 25, Heagle teaches the system of claim 1. Heagle does not teach wherein at least some of the standoffs form protrusions on one side of the tissue interface.
However, Wada teaches wherein at least some of the standoffs form protrusions on one side of the tissue interface (flat sheet material 4/fluid control layer has a surface that is adjacent to the sheet 2 comprising protrusions 3 on one side of sheet; Paragraphs 0046-0054; Figures 4 and 5).
Heagle and Wada are both considered to be analogous to the claimed invention because they are in the same field of absorbent articles. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Wada and have the protrusions on only one side of the sheet, as taught by Wada. This will allow for the flat area, made of the flat sheet, to be easily joined to another sheet for making absorbent articles (Wada; Paragraph 0048-0049).
Regarding claim 28, Heagle in view of Wada teaches the system of claim 25. The combination of Heagle in view of Wada further teaches wherein at least some of the protrusions have a shape that is spherical, circular, polygonal or any combination thereof (Heagle; pods 258/260/262 are circular; Figures 8A-8B).
Claim 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 4 above, and further in view of Simmons et al. (Publication No. US 2011/0224631 A1).
Regarding claim 12, Heagle teaches the system of claim 4. Heagle does not teach wherein at least some of the cells have perforations.
However, Simmons teaches wherein at least some of the cells have perforations (fenestrations 203 on flow paths 210; Figure 2; Paragraph 0041 and 0046-0047).
Heagle and Simmons are considered to be analogous to the claimed invention because they are in the same field of wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Simmons and incorporate the fenestrations of Simmons on some of the closed cells of Heagle. This will enable negative pressure and fluids to travel through the layer through the openings (Simmons; Paragraph 0041).
Regarding claim 13, Heagle in view of Simmons teaches the system of claim 12. The combination of Heagle in view of Simmons further teaches wherein the perforations comprise slits or crosshatches (Simmons; fenestrations are slits or linear cuts and can be any shape or size; Paragraph 0030 and 0041). Simmons does not expressly teach wherein the perforations comprise slits of between 0.5 to 2 mm in width.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the perforations/fenestrations of Heagle in view of Simmons to have slits of between 0.5 to 2 mm in width 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)(MPEP 2144.04(IV)(A)). In the instant case, the system of Heagle in view of Simmons would not operate differently with the claimed slit width since the therapy delivery system with the fenestrations/perforations have the same function of being a wound dressing that delivers negative pressure at the tissue site and allowing fluid to travel through the cell (Simmons; Abstract; Figure 1 and 2; Paragraph 0041). Further, applicant places no criticality on the range claimed, indicating simply that the apertures “may” be within the claimed ranges (specification; paragraph 0066).
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1) in view of Wada (Publication No. US 2015/0290050 A1), as applied to claim 25 above, and further in view of Simmons et al. (Publication No. US 2011/0224631 A1).
Regarding claim 34, Heagle in view of Wada teaches the system of claim 25. The combination of Heagle in view of Wada does not teach wherein at least some of the protrusions have perforations.
However, Simmons teaches wherein at least some of the protrusions have perforations (fenestrations 203 on flow paths 210; Figure 2; Paragraph 0041 and 0046-0047).
Heagle in view of Wada and Simmons are considered to be analogous to the claimed invention because they are in the same field of wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle in view of Wada to incorporate the teachings of Simmons and incorporate the fenestrations of Simmons on some of the closed cells of Heagle in view of Wada. This will enable negative pressure and fluids to travel through the layer through the openings (Simmons; Paragraph 0041).
Regarding claim 35, Heagle in view of Wada and Simmons teaches the system of claim 34. The combination of Heagle in view of Wada and Simmons further teaches wherein the perforations comprise slits or crosshatches (Simmons; fenestrations are slits or linear cuts and can be any shape or size; Paragraph 0030 and 0041). Simmons does not expressly teach wherein the perforations comprise slits of between 0.5 to 2 mm in width.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the perforations/fenestrations of Heagle in view of Wada and Simmons to have slits of between 0.5 to 2 mm in width 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)(MPEP 2144.04(IV)(A)). In the instant case, the system of Heagle in view of Wada and Simmons would not operate differently with the claimed slit width since the therapy delivery system with the fenestrations/perforations have the same function of being a wound dressing that delivers negative pressure at the tissue site and allowing fluid to travel through the cell (Simmons; Abstract; Figure 1 and 2; Paragraph 0041). Further, applicant places no criticality on the range claimed, indicating simply that the apertures “may” be within the claimed ranges (specification; paragraph 0066).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 1 above, and further in view of Coulthard et al. (Publication No. US 2017/0128269 A1).
Regarding claim 19, Heagle teaches the system of claim 1. Heagle does not teach wherein the biocompatible polymer comprises oxidized regenerated cellulose.
However, Coulthard teaches wherein the biocompatible polymer comprises oxidized regenerated cellulose (oxidized regenerated cellulose is bonded to upstream or downstream layer; Paragraph 0041; Figure 1).
Heagle and Coulthard are analogous to the claimed invention, in the field of wound covers, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Coulthard and incorporate the material of Coulthard as the biocompatible polymer of Heagle. This will enable the device to improve re-epithelialization time in chronic wounds (Coulthard et al.; Paragraph 0041).
Claim(s) 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 1 above, and further in view of Lauritzen et al. (Publication No. US 2011/0262515 A1).
Regarding claim 18, Heagle teaches the system of claim 1. Heagle does not teach wherein the biocompatible polymer comprises collagen.
However, Lauritzen teaches wherein the biocompatible polymer comprises collagen (cross-linked collagen as a wound repair material; Paragraph 0065).
Lauritzen and Heagle are both considered to be analogous to the claimed invention because they are in the same field of wound repair systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Lauritzen and incorporate the collagen of Lauritzen as the biocompatible polymer of Heagle. The collagen improves the mechanical and chemical properties of the material for wound repair (Lauritzen et al.; Paragraph 0002).
Regarding claim 20, Heagle teaches the system of claim 1. Heagle does not teach wherein the biocompatible polymer comprises cross-linked collagen.
However, Lauritzen teaches wherein the biocompatible polymer comprises cross-linked collagen (cross-linked collagen as a wound repair material; Paragraph 0065).
Lauritzen and Heagle are considered to be analogous to the claimed invention because they are in the same field of wound repair systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Lauritzen and incorporate the cross-linked collagen of Lauritzen as the biocompatible polymer of Heagle. The cross-linked collagen improves the mechanical and chemical properties of the material for wound repair (Lauritzen et al.; Paragraph 0002).
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 1 above, and further in view of Russ et al. (U.S. Patent Application No. 2011/0237994 A1).
Regarding claim 36, Heagle teaches the system of claim 1. Heagle does not teach wherein the biocompatible polymer is in a form of a liquid slurry.
However, Russ teaches wherein the biocompatible polymer is in a form of a liquid slurry (release agent is a slurry of clay and release agent; Paragraph 0044).
Russ and Heagle are considered to be analogous to the claimed invention because they are in the same field of wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Russ and incorporate the slurry form of Russ as the biocompatible polymer of Heagle. The slurry allows for the stable suspension of the material and the release agent in the wound system (Russ et al.; Paragraph 0042 and 0044).
Claim(s) 37 is rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 1 above, and further in view of Carr et al. (U.S. Patent Application No. 2019/0083675 A1).
Regarding claim 37, Heagle teaches the system of claim 1. Locke does not teach wherein the biocompatible polymer is in a powder form.
However, Carr teaches wherein the biocompatible polymer is in a powder form (inclusions in the recesses of layer is in powder form; Paragraph 0122).
Carr and Heagle are considered to be analogous to the claimed invention because they are in the same field of absorbent dressings/pads. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Carr and incorporate the powder form of Carr as the biocompatible polymer of Heagle. This allows for the desired material to be deposited into the absorbent article using a variety of dispensers (Carr et al.; Paragraph 0122).
Claim(s) 51 is rejected under 35 U.S.C. 103 as being unpatentable over Heagle et al. (Publication No. US 2013/0204213 A1), as applied to claim 1 above, and further in view of Argenta et al. (Patent No. US 5,645,081 A).
Regarding claim 51, Heagle teaches the system of claim 1. Heagle does not teach wherein the specified time period is between about 2 days and about 21 days.
However, Argenta teaches wherein the specified time period is between about 2 days and about 21 days (Column 3, lines 19-28).
Argenta and Heagle are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heagle to incorporate the teachings of Argenta and incorporate the treatment time period of Argenta using the system of Heagle. This allows for the treatment to be applied onto the wound until the wound actually closes during healing and prevent infection (Argenta; Column 3, lines 19-29 and 48-57).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781