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 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.
Claims 1-3, 6, 9-12, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20200121509 A1) in view of Hartwell et al. (US 20200121510 A1).
Regarding Claim 1, Locke discloses an apparatus (figs 1-2) comprising:
a flexible and porous gas permeable treatment patch (110; 120 is porous and hydrophobic [0057,0073,0078,0080,0085,0087]) configured to be releasably secured to a user's body such that an exterior surface 120,215 of the treatment patch directly contacts skin on the user's body; and
a generating unit (105,150 of positive and/or negative pressure to deliver saline solution [0047]; fig 1) fluidically coupled to the treatment patch and configured to provide a flow of positive pressure source through exposed pores (in layers 205, 210, and 215) in the treatment patch toward the exterior surface of the treatment patch and then out through the exterior surface of the treatment patch [0085,0087,0088]. Locke discloses the invention substantially as claimed. However, it fails to disclose the generating unit using ozone.
Hartwell teaches a wound therapy system including a positive or negative pressure source 150 to treat the wound with oxygen, ozone, or other fluids or gas [0081]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke’s generating unit by using Hartwell’s teaching of the generating unit using ozone since ozone is a well-known to help with wound healing as an alternative option.
Regarding Claim 2, Locke discloses wherein the exterior surface of the treatment patch exhibits hydrophobic properties to allow for contact with fluids without blocking the exposed pores thereof (215, [0085,0087,0088]).
Regarding Claim 3, Locke discloses wherein the treatment patch 120 includes a wound contact layer (215) that includes the exterior surface of the treatment patch 120, a backing (125), and a bonding layer 255 [0058,0091] securing the wound contact layer to the backing 125.
Regarding Claim 6, Locke discloses the treatment patch further includes an intermediate flow dispersion layer 205 [0072-0074] enclosed between the wound contact layer and the backing that is configured to promote uniform output flow from the exterior surface of the treatment patch.
Regarding Claim 9, Locke discloses a method of treating a wound site on a patient [0047], the method comprising:
releasably securing a flexible and porous gas permeable treatment patch 110 [0091] of a positive/negative source 150 generation apparatus to a user's body such that an exterior surface 120,215 of the treatment patch directly contacts skin comprising the wound site on the user's body;
generating instillation fluid with generating unit 150 fluidically coupled to the treatment patch [0047]; and
providing a flow of instillation fluid via generating unit 150 through pores in the treatment patch toward the exterior surface of the treatment patch and then out through the exterior surface of the treatment patch 215 such that the instillation contacts the wound site.
However, Locke fails to disclose the generating ozone instead of using saline.
Hartwell teaches a wound therapy system and method of using including a positive or negative pressure source 150 to treat the wound with oxygen, ozone, or other fluids or gas [0081]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke’s generating unit by using Hartwell’s teaching of the generating unit using ozone since ozone is a well-known to help with wound healing as an alternative option.
Regarding Claim 10, Locke discloses wherein the treatment patch comprises a hydrophobic coating on the exterior surface [0087] such that the exterior surface exhibits hydrophobic properties to allow for contact with fluids without blocking the exposed pores thereof, the method further comprising reducing uptake of biofluids into the wound contact layer 100 with the hydrophobic coating [0087].
Regarding Claim 11, Locke discloses wherein the treatment patch 110 comprises a wound contact layer 215 that includes the exterior surface of the treatment patch, a backing 125, and a bonding layer 255 securing [0058,0091] the wound contact layer to the backing.
Regarding Claim 12, Locke discloses wherein the treatment patch comprises an intermediate flow dispersion layer 205 [0072-0074] enclosed between the wound contact layer and the backing, the method further comprising promoting uniform output flow from the exterior surface of the treatment patch with the intermediate flow dispersion layer.
Regarding Claims 16-17, Locke/Hartwell discloses the invention substantially as claimed. However, it fails to disclose the step of providing the flow of ozone comprises delivering a concentration of ozone to the wound site of below 0.6 g/mL, and further comprising delivering a concentration of ozone to the wound site of 0.2 g/mL to below 0.6 g/ml. The instant disclosure describes these concentrations as merely preferable. Therefore, these concentrations are deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding Claims 18 and 19, Locke discloses the invention substantially as claimed. However, it fails to disclose the ozone generating unit is a portable ozone generating unit, the method further comprising mounting the portable ozone generating unit to the patient; and the mounting comprises attaching the portable ozone generating unit to clothing worn by the patient.
Hartwell teaches a wound therapy system and method of using including a positive or negative pressure source 150 to treat the wound with oxygen, ozone, or other fluids or gas [0081] to be portable and/or attached or adjacent to the dressing making it [0030]. This implies to be carried by a patient. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke’s generating unit and system with the portability taught by Hartwell, since such modification would have enhanced patient treatment with the portable manner.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20200121509 A1) in view of Hartwell (US 20230263666 A1), further in view of Larsen et al (US 20110021964 A1).
Locke discloses a coating on the exterior surface of the treatment patch [0087]. However, it fails to disclose the coating on the exterior surface of the treatment patch configured to dissolve or degrade upon contact with a wound site of the skin and thereby release an antibiotic payload onto the wound site, and or the coating comprising an antibiotic payload on the exterior surface of the treatment patch configured to dissolve or degrade upon contact with the wound site of the skin, the method further comprising dissolving or degrading the coating upon contact with the wound site to release the antibiotic payload onto the wound site.
Larsen teaches a wound treatment dressing/patch (figure 2B, matrix material, [0284] including a coating on the exterior surface [0087-0088] that has been sprayed or can be sprayed (fig 1a; [0162]) configured to dissolve or degrade upon contact with the wound site of the skin and thereby release an antibiotic payload on the wound site [0194-0195, 0199, 0205-208], [0231], [0308], [0374]].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke treatment patch coating and treatment with Larsen’s surface coating in order to enhance the healing process of the treatment patch.
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20200121509 A1) in view of Hartwell (US 20230263666 A1), further in view of Larsen et al (US 20110021964 A1) as applied to claims 7 and 13 above, and further in view of Soldani et al. (US 20120070485 A1).
Locke /Hartwell/Larsen discloses the invention substantially as claimed. However, they fail to disclose the coating including polymeric nanofibers having the antibiotic payload therein.
Soldani teaches a treatment patch including a fibrin layer (biological interaction layer 12) with nanofibers [0035] that can be further include antibiotics [0004, 0061; Abstract].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke/Hartwell/Larsen treatment patch coating by incorporating Soldani’s teaching of the coating including polymeric nanofibers having the antibiotic payload therein since such modification would enhance the healing process (Soldani [0004]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20200121509 A1) in view of Hartwell (US 20230263666 A1) as applied to claim 3 above, and further in view of Lina (US 20040006319 A1).
Regarding claim 4, Locke /Hartwell discloses the invention substantially as claimed. However, they fail to disclose the wound contact layer includes a synthetic Rayon-Spandex knit fabric.
Lina teaches in figure 18 a porous wound pad 203 including an affixed smooth porous membrane 219 of Rayon-Spandex knit fabric on the pad [0056]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke’s contact layer with Lina’s teaching of including a Rayon-Spandex knit fabric to the layer for extending the pressure through the pad.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20200121509 A1) in view of Hartwell (US 20230263666 A1) as applied to claim 3 above, and further in view of Adie et al (RU 2596054 C2).
Regarding claim 5, Locke discloses in [0087] that a coating of silicone can be added to the exterior surface 215 of the patch. However, it fails to disclose the exterior surface of the treatment patch as being coated with polydimethylsiloxane (PDMS).
Adie teaches a wound contact surface that includes a silicone-based adhesive [0117] such as polydimethylsiloxane. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke’s the exterior surface of the treatment patch is coated with polydimethylsiloxane (PDMS), since it would enhance the adhesion of the wound contact patch surface.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20200121509 A1) in view of Hartwell (US 20230263666 A1) as applied to claim 9 above, and further in view of Wainwright (US 5052382 A).
Regarding claim 4, Locke /Hartwell discloses the invention substantially as claimed. However, they fail to disclose the portable ozone generating unit comprises an ozone generator and a micro-blower fan, the method further comprising: generating ozone in a sealed chamber with the ozone generator; and blowing the ozone produced by the ozone generator with the micro-blower fan from the sealed chamber to the treatment patch through tubing fluidically connecting an outlet of the sealed chamber to an inlet on the treatment patch.
Wainwright teaches an ozone generator 4 and a micro-blower fan 28 (fig 2) helping to disperse the ozone from the ozone generator (col 6, lines 3-41). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Locke/Hartwell ozone generating device with Wainwright’s ozone generator and micro-blower fan teaching in order to blow the ozone produced into the treatment patch.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection.
Response to Amendment
Declaration under 37 CFR 1.130(a) is sufficient to overcome the paper entitled "Wearable and Flexible Ozone Generating System for Treatment of Infected Dermal Wounds," published May 19, 2020, in Frontiers in Bioengineering and Biotechnology, Volume 8, Article 458; doi: 10.3389/fbioe.2020.00458 (hereinafter referred to as "the Roth Article").
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
THIS ACTION IS MADE FINAL. 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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