DETAILED ACTION
This Office Action is in response to the Preliminary Amendment filed June 17, 2025. Claims 15, 17-26, 32, 33 and 35-46 have been cancelled. Claims 1-14, 16, 27-29, 31 and 34 are pending.
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 .
Information Disclosure Statement
The information disclosure statements filed April 22, 2024 have been received and made or record. Note the acknowledged PTo-1449 forms enclosed herewith.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-13 and 16 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
With respect to claim 1, the claim recites the “a manifold extending over a wound” in line 4 and “the drape layer sealingly coupling with skin surround the wound” in lines 8-9. These recitations incorporate portions of the human body along with the invention. Applicant is advised to amend the claim to recite “a manifold configure to extend over a wound” in line 4 and “the drape layer configured to sealingly couple with skin surround the wound” in lines 8-9. Claims 2-13 are necessarily rejected for indirectly containing the rejected language by virtue of their dependence on claim .
With respect to claim 16, the claim recites “a manifold extending over a wound” in line 2 and “the drape layer sealingly coupling with skin surround the wound” in lines 7-8. Applicant is advised to amend the claim to recite “a manifold configure to extend over a wound” in line 4 and “the drape layer configured to sealingly couple with skin surround the wound” in lines 8-9.
Claim Rejections - 35 USC § 102
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 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, 14, 16, 27, 29 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 10,918,770 (herein after “Fewkes”).
Regarding claim 1, Fewkes discloses a wound dressing for use with a negative pressure wound therapy (NPWT) device (note the title which discloses vacuum assisted wound closure), the wound dressing comprising: a manifold layer (wound insertion foam layer 110, see col. 2, lines 64-65 Fig. 1) extending over a wound for NPWT (see Fig. 1; the foam extends in the wound and over the wound bed); a lightguide (light diffusing optical fiber 140, see col. 2, lines 66) positioned below the manifold layer and above the wound (see Fig. 1 which shows the manifold extending over the wound bed), the lightguide configured to receive light at a first portion, transfer the light through the lightguide, and emit the light towards the wound at a second portion for phototherapy of the wound (see col. 1, lines 33-42 which discloses “The light diffusing optical fiber includes one or more light scattering structures distributed along at least a treatment length of the light diffusing optical fiber. Further, at least a portion of the treatment length of the light diffusing optical fiber is positioned within a wound tissue region of the wound, the wound cavity, or both, such that at least a portion of light emitted by the therapeutic light source enters the light diffusing optical fiber, scatters outward from the light diffusing optical fiber, and irradiates the wound tissue region, a wound cavity surface of the wound, or both”; thus light enters in the light guide and diffuses it at a second location); a drape layer (sealing layer 120, see Fig. 1 and col. 2, line 65) covering the manifold layer and the lightguide (see Fig. 1), the drape layer sealingly coupling with skin surrounding the wound and defining a sealed inner volume of the wound dressing (see col. 1, lines 47-49 discloses the sealing layer comprises a sealing surface such that it seals the wound foam within the cavity); wherein the drape layer comprises a first opening (vacuum entry point, 128) for drawing a negative pressure at the sealed inner volume of the wound dressing, and a second opening (fiber entry point 128) for providing light to the first portion of the lightguide for phototherapy of the wound (see Figs. 1 and 2 and col. 4, lines 19 discloses “[r]eferring still to FIGS. 1 and 2, a vacuum entry port 126 extends through the wound sealing layer 120. The drain tube 130 may extend into the vacuum entry port 126, for example, through the vacuum entry port 126, such that the drainage end 132 of the drain tube 130 is fluidly coupled to the wound insertion foam 110. The light diffusing optical fiber 140 may extend within the drain tube 130 and extend through the vacuum entry port 126. Further, the light diffusing optical fiber 140 may extend through the vacuum entry port 126, adjacent the drain tube 130. Moreover, the wound sealing layer 120 may comprise a fiber entry port 128 extending through the wound sealing layer 120 at a location apart from the vacuum entry port 126 and the light diffusing optical fiber 140 may extend through the fiber entry port 128 and into the wound cavity 12”).
Regarding claim 14, Fewkes discloses a negative pressure wound therapy (NPWT) and phototherapy system (100), the system comprising: a wound dressing (foam layer 110 and sealing layer 120, see col. 2, lines 62-65, and light diffusing optical fiber 140, see col. 2, lines 66 ) configured to cover a wound (see Fig. 1, note wound cavity 12 in col. 6, lines 58-66); a therapy device (vacuum source 110 and drain tube 130, see Fig. 2 and col. 7, lines 3-11) configured to draw a negative pressure at the wound for NPWT (col. 1, lines 49-57 and see the title); and a light source (light source160) configured to provide light to the wound within the wound dressing for photo therapy (col. 7, line 63-col. 8, line 4 recites “ the therapeutic light source 160 optically coupled to the light diffusing optical fiber 140 such that at least a portion of light emitted by the therapeutic light source 160 enters the light diffusing optical fiber 140, scatters outward from the light diffusing optical fiber 140, and irradiates the wound tissue region 16 of the wound 10”); wherein the system is configured to provide both NPWT and phototherapy to the wound consecutively or at least partially concurrently (the system is configured to use both negative pressure therapy and phototherapy concurrently; the abstract disclose both treatments), wherein providing NPWT changes a surface topology of the wound prior to or at least partially concurrently with providing phototherapy (since the system assists with wound healing, it is inherent that the negative pressure will change the surface topology of a wound specifically since it assist with wound closure, see the title).
Regarding claim 16, Fewkes system of Claim 14, wherein the wound dressing comprises: a manifold layer (wound insertion foam layer 110, see col. 2, lines 64-65 Fig. 1) extending over a wound for NPWT (see Fig. 1; the foam extends in the wound and over the wound bed); a lightguide (light diffusing optical fiber 140, see col. 2, lines 66) positioned below the manifold layer and above the wound (see Fig. 1 which shows the manifold extending over the wound bed), the lightguide configured to receive light at a first portion, transfer the light through the lightguide, and emit the light towards the wound at a second portion for phototherapy of the wound (see col. 1, lines 33-42 which discloses “The light diffusing optical fiber includes one or more light scattering structures distributed along at least a treatment length of the light diffusing optical fiber. Further, at least a portion of the treatment length of the light diffusing optical fiber is positioned within a wound tissue region of the wound, the wound cavity, or both, such that at least a portion of light emitted by the therapeutic light source enters the light diffusing optical fiber, scatters outward from the light diffusing optical fiber, and irradiates the wound tissue region, a wound cavity surface of the wound, or both”; thus light enters in the light guide and diffuses it at a second location); a drape layer (sealing layer 120, see Fig. 1 and col. 2, line 65) covering the manifold layer and the lightguide (see Fig. 1), the drape layer sealingly coupling with skin surrounding the wound and defining a sealed inner volume of the wound dressing (see col. 1, lines 47-49 discloses the sealing layer comprises a sealing surface such that it seals the wound foam within the cavity); wherein the drape layer comprises a first opening (vacuum entry point, 128) for drawing a negative pressure at the sealed inner volume of the wound dressing, and a second opening (fiber entry point 128) for providing light to the first portion of the lightguide for phototherapy of the wound (see Figs. 1 and 2 and col. 4, lines 19 discloses “[r]eferring still to FIGS. 1 and 2, a vacuum entry port 126 extends through the wound sealing layer 120. The drain tube 130 may extend into the vacuum entry port 126, for example, through the vacuum entry port 126, such that the drainage end 132 of the drain tube 130 is fluidly coupled to the wound insertion foam 110. The light diffusing optical fiber 140 may extend within the drain tube 130 and extend through the vacuum entry port 126. Further, the light diffusing optical fiber 140 may extend through the vacuum entry port 126, adjacent the drain tube 130. Moreover, the wound sealing layer 120 may comprise a fiber entry port 128 extending through the wound sealing layer 120 at a location apart from the vacuum entry port 126 and the light diffusing optical fiber 140 may extend through the fiber entry port 128 and into the wound cavity 12”).
Regarding claim 27, Fewkes discloses the system of Claim 14, wherein the light source is positioned external to the wound dressing (light source 160 is positioned external to the dressing, see Fig. 2 and col. 2, line 67).
Regarding claim 29, Fewkes discloses the system of Claim 14, wherein the light provided by the light source is at least one of visible light, UV light, blue light, infrared light, near infrared light, or red light (UV light is disclosed at col. 4, lines 31-41).
Regarding claim 34, Fewkes discloses the system of Claim 14, wherein the light source is configured to operate to provide light having a first wavelength over a first time period and light having a second wavelength over a second time period to provide different types of phototherapy (note col. 4, lines 31-52 which discloses “the therapeutic light source 160 may emit light comprising a wavelength between about 250 nm and about 1100 nm, for example 250 nm, 350 nm, 405 nm, 445 nm, 530 nm, 630 nm, 650 nm, 700 nm, between about 780 nm and about 980 nm, or the like. For example, the therapeutic light source 160 may emit light at wavelengths that activate, alter, or otherwise react with one or more photo-active pharmaceuticals. For example, Photofrin™ may be activated by emitted light having wavelengths between about 600 nm and about 680 nm, or wavelengths near UV wavelengths, such as between about 370 nm and about 420 nm Further, the therapeutic light source 160 may emit a pulsed light. For example, the pulsed light may be pulsed at frequency within a treatment frequency range comprising between about 70 Hz and 80 Hz, between about 145 Hz and 155 Hz, between about 290 Hz and 300 Hz, between about 585 Hz and 595 Hz, between about 1170 Hz and about 1180 Hz, between about 2345 Hz and about 2355 Hz, or between about 4695 Hz and about 4705 Hz. Further, the treatment frequency range may encompass one or more of the Noiger frequencies, for example, 73 Hz, 147 Hz, 294 Hz, 587 Hz, 1174 Hz, 2349 Hz, 4698 Hz, or the like”; therefore since the light source may operate at different wavelengths and different frequencies, it is configured to operate to provide light having a first wavelength over a first time period and light having a second wavelength over a second time period to provide different types of phototherapy).
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) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fewkes in view of U.S. Patent No 6,096,066 (hereinafter ”Chen”).
Regarding claim 2, Fewkes discloses the wound dressing of Claim 1, except wherein the lightguide comprises a plurality of openings extending through the lightguide, the plurality of openings configured to define a path for fluid to transfer from the wound to the manifold layer through the lightguide when the negative pressure is drawn at the wound.
However, Chen in its disclosure an analogous light guide (patch 40) for light therapy teaches it is known to provide a light guide with an array of horizontal slots (48) and vertical slots (46) that extend through the flexible substrate and thin layer (28). Each of these slots comprise open passages through which air and moisture are readily conveyed when flexible patch (40) is applied to the treatment site on the patient's body (see col. 3, lines 65-67 and see Fig. 3) .
In view of Chen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have modified Fewkes by adding slots to the light guide through which air and moisture are readily conveyed to treat the wound site.
Regarding claim 3, modified Fewkes discloses the wound dressing of Claim 2, except wherein the plurality of openings are arranged in an array. However, as can be read from the rejection of claim 2 above, Chen also teaches it is known to construct the slots in an array as shown in Fig. 3.
In view of Chen, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have modified Fewkes by adding an array slots to the light guide such air and moisture are evenly and readily conveyed throughout light guide to treat the wound site.
Regarding claim 4, modified Fewkes discloses the wound dressing of Claim 3, except wherein at least one of a size or a shape of the openings varies along at least one dimension of the array. However, as can be read from the rejection of claim 3 above and seen from Fig. 3, Chen discloses horizontal slots (48) and vertical slots (46); thereby teaching the shapes vary along at least one dimension of the array.
In view of Chen, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have modified Fewkes by adding such shaped passages to prevent irritation and heat buildup at the treatment site covered by light guide since moisture and wound exudate passes through these passages comprising horizontal slots and vertical slots so that the patient is more comfortable during an extended period of light therapy (see col. 5, lines 15-20 of Chen).
Regarding claim 5, modified Fewkes discloses the wound dressing of Claim 3, except wherein the size and shape of the openings is uniform along at least one dimension of the array. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have modified Fewkes by adding uniform slots in at lest one dimension of the array when the wound has a planar shape with significant surface irregularities and that not does require significant conforming.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fewkes in view of U.S. Patent No. 9,918,733 (hereinafter “Ingram”).
Regarding claim 6, Fewkes discloses wound dressing of Claim 1, except wherein the wound dressing is configured for use with a coupler assembly, the coupler assembly comprising a coupler configured to couple with the first opening and the second opening of the drape layer for drawing the negative pressure at the wound and for providing light to the lightguide for phototherapy. However, Ingram in its disclosure of an analogous wound therapy system (100) teaches it is known to provide a wound dressing providing two treatments with a coupler assembly (connectors 114,124) as a means for providing stabilized connection of instillation fluid tube (122) and vacuum tube drain tube (116) to the drape (see Fig. 1).
In view it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have modified Fewkes by adding a coupler assembly for stabilized connection of the drain tube (130) and optical fiber (140) at the first and second openings in the drape.
Claim(s) 13 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 7,304,201 (hereinafter “Holloway”).
Regarding Fewkes discloses the wound dressing of Claim 1, except wherein an interior surface of the drape layer comprises a reflective material, wherein the reflective material is configured to reflect light towards the wound to improve an efficacy of the phototherapy. However, Fewkes discloses in col. 3, line 58-col. 4, line 3 that “the wound sealing layer 120 may be opaque such that at least some light emitted into the wound cavity 12 by the light diffusing optical fiber 140 is inhibited from traversing the wound sealing layer 120. For example, it may be advantageous for the wound sealing layer 120 to be opaque when the light diffusing optical fiber 140 emits ultraviolet light. Further, an opaque layer 180 may be coupled to the wound sealing layer 120, for example, to the outward surface 124 and/or the sealing surface 122 of the wound sealing layer 120 such that such that at least some light emitted into the wound cavity 12 by the light diffusing optical fiber 140 is inhibited from traversing the opaque layer 180.” Therefore, the opaque material performs similarly as same as the clamed reflective material by preventing the emitted by traversing through the sealing layer.
Holloway in the disclosure of analogous phototherapy treatment device (bandage 10) teaches it is known to provide a light source (12, see col. 5, lines 1-4), wherein the light source is positioned within the therapy device and wherein the device a reflective backing (15) which prevents light produced by the light source is reflected and not transferred through the barrier.
In view of Holloway, it would have been obvious to one having ordinary skill in the art before the filing of the claimed invention to have substituted the opaque sealing for a reflective sealing layer in order to ensure that all diffused light is reflected back to the wound and not passed through the sealing layer.
Regarding claim 28, Fewkes discloses the system of Claim 14, except wherein the light source is positioned within the therapy device. However, Holloway in the disclosure of analogous phototherapy treatment device (bandage 10) teaches it is known to provide a light source (12, see col. 5, lines 1-4), wherein the light source is positioned within the therapy device for allowing the user to wear the device without interfering with the patient’s daily routine (see abstract).
In view of Fewkes, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have incorporated the light source, such as a led light, within the device in order to allow the user to receive phototherapy without interfering with the patient’s daily routine.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fewkes in view of U.S. Patent No. 6,290,713 (hereinafter “Russel”).
Regarding claim 31, Fewkes discloses the system of claim 14, wherein the light provided by the light source is visible light (note the disclosure of light in the visible wavelength spectrum of 380-780 nanometers, see the disclosure of 405 nm in col. 4, lines 31-33).
Fewkes fails to disclose a plurality of microfilm layers are positioned between the light source and the wound, wherein the plurality of microfilm layers are configured to filter the light so that light having a different wavelength is provided to the wound for the phototherapy. However, Russel in the disclosure of an analogous phototherapy device teaches it is known to provide interface layers in the form of filters (110), such a multilayer thin film between light source and patient’s skin to reflect and absorb certain wavelengths of light (see col. 14, lines 15-20 and lines 49-55).
In view of Russel, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided the device of Fewkes with a multilayer film positioned between the wound and light source during use in order to absorb certain wavelengths to prevent damage or injury.
Reasons for Not Providing Art Rejections for claim 7-12
U.S. Patent to Fewkes et al., the closest prior art of record, modified with couples do not disclose the subject matter of claim 7. Specifically, not disclosed or rendered obvious is a coupler assembly comprising a second tubular member is operably coupled with the second opening for delivering light to the wound for phototherapy since element (140) has been designated as the lightguide and cannot be used as a second tubular member in claim 7.
U.S. Patent No. 2020/0046569 to Quisenberry discloses a combination phototherapy and negative pressure therapy system. Quisenberry however does not disclose the combined features of claims 1, 6 and 7. Specifically, Quisenberry fails to teach, suggest or render obvious a coupler assembly comprising a first tubular member and a second tubular member, wherein the first tubular member is configured to fluidly couple with the first opening of the wound dressing through the coupler for drawing the negative pressure at the wound and the second tubular member is operably coupled with the second opening for delivering light to the wound for phototherapy in combination with the recited elements of claims 1 and 6.
U.S. Patent No. 6,994,702 to Johnson discloses a combination phototherapy and negative pressure therapy system Johnson however does not disclose the combined features of claims 1, 6 and 7. Specifically, Johnson fails to teach, suggest or render obvious a coupler assembly comprising a first tubular member and a second tubular member, wherein the first tubular member is configured to fluidly couple with the first opening of the wound dressing through the coupler for drawing the negative pressure at the wound and the second tubular member is operably coupled with the second opening for delivering light to the wound for phototherapy in combination with the recited elements of claims 1 and 6.
The features recited in claim 7 are therefore novel when combined with the claims from which it depends, namely claims 1 and 6. Further, claims 8-12 have not been given prior art rejections virtue of their dependence on claim 7.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786