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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 42-61 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 42 recites the limitation “a plurality of cutouts forming a plurality of sensor array portions supporting the one or more sensors…the plurality of sensor array portions comprising: a plurality of sensor array portions that are positioned around a perimeter of the substantially flexible substrate” (emphasis added). It is unclear if the underlined “a plurality of sensor array portions” refers to the same plurality of sensor array portions previously recited in the claim or if the underlined portion refers to a subset of the previously recited plurality of sensor array portions. For the purpose of compact prosecution, the underlined limitation is interpreted as a subset of the plurality of sensor array portions.
Claims 43-61 are also rejected based on their dependency on Claim 42.
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) 42, 43, 46-55, 58, 60, and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgmann (US 2012/0116485) in view of McChrystal et al (US 2014/0062462).
Regarding Claim 42, Burgmann discloses a wound monitoring apparatus (50, Figs. 1-2), comprising:
a wound dressing (phototherapy bandage 52, Figs. 1-2) configured to be positioned in contact with a wound (¶ [0050]), the wound dressing (52, Figs. 1-2) comprising a substantially flexible substrate (emitter and sensor assembly 70, Figs. 1-2; ¶ [0055, 0067]; the cables connecting the segments are flexible and therefore the substrate can be considered flexible as segments can flex relative to one another) supporting one or more sensors (¶ [0055, 0067]), the substantially flexible substrate comprising:
a plurality of cutouts (gaps between segments, Fig. 2) forming a plurality of sensor array portions (segments 100, 102, and 103, Fig. 2) supporting the one or more sensors (¶ [0054]), the plurality of cutouts forming gaps between adjacent sensor array portions (100, 102, 103, Fig. 2), wherein the gaps are configured to minimize blocking of fluid flow through the substantially flexible substrate (¶ [0051]; the gaps are fully capable of allowing fluid to flow through the gaps and therefore are fully capable of minimizing blocking of fluid flow through the substrate), the plurality of sensor array portions (100, 102, 103, Fig. 2) comprising:
a plurality of sensor array portions (100, 102, 103, Fig. 2) that are positioned around a perimeter of the substantially flexible substrate (70, Fig. 2).
Burgmann is silent whether the plurality of sensor array portions comprise a plurality of linearly extending sensor array portions that extend inwardly from the perimeter of the substantially flexible substrate.
McChrystal teaches a printed circuit board usable with medical devices, thus being in the same field of endeavor, with a plurality of linearly extending sensor array portions (extensions 230, Fig. 11) that extend inwardly from the perimeter (outer region 220, Fig. 11) of the substantially flexible substrate (circuit board 202, Fig. 11). These extensions allow for individual positioning of the sensors at the end of the extensions (¶ [0123]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substantially flexible substrate of Burgmann to include a plurality of linearly extending sensor array portions that extend inwardly from the perimeter of the substantially flexible substrate, as taught by McChrystal, to allow for individual positioning of the sensors at the end of the extensions (as motivated by McChrystal ¶ [0123]). This would allow individual control over what sensors contact the wound and where specifically they contact the wound.
Regarding Claim 43, the combination of Burgmann/McChrystal substantially discloses the claimed invention as claimed as set forth above in Claim 42.
The combination of Burgmann/McChrystal will additionally disclose the plurality of linearly extending sensor array portions comprise a first plurality of parallel linearly extending sensor array portions that are perpendicular to a second plurality of linearly extending sensor array portions, as some of the linearly extending sensor array portions will extend in the longitudinal direction and others will extend in the lateral direction, those directions being perpendicular to each other.
Regarding Claim 46, Burgmann further discloses the substantially flexible substrate (70, Fig. 2) is a substantially flexible printed circuit (¶ [0053, 0055, 0067]; although the circuit board is rigid, due to the gaps between segments the overall substrate is flexible).
Regarding Claim 47, the embodiment of Figs. 1 and 2 of Burgmann is silent whether the substantially flexible printed circuit comprises a flexible polymer. However, the embodiment of Figs. 11-13 of Burgmann has a substantially flexible printed circuit comprising a flexible polymer (¶ [0068]) and indicates that this type of circuit board is an alternative to the rigid printed circuit boards of the embodiment of Figs. 1 and 2 (¶ [0067]). Therefore, one of ordinary skill in the art would have found it obvious to modify the circuit board of Burgmann/McChrystal to comprise a flexible polymer, as taught by embodiment of Figs. 11-13 of Burgmann, to increase the flexibility of the sensor substrate and therefore the dressing as a whole (as motivated by Burgmann ¶ [0067-0068]).
Regarding Claim 48, Burgmann further discloses the one or more sensors (¶ [0054]) are electrically connected with each other (¶ [0055]), wherein the one or more sensors are further configured to be electrically connected with a controller (54, Fig. 1) and a power source (146, Fig. 7; ¶ [0056-0059]).
Regarding Claim 49, Burgmann further discloses the one or more sensors comprise one or more temperature sensors (¶ [0054]).
Regarding Claim 50, Burgmann further discloses a controller (54, Fig. 1) in electrical communication with the one or more sensors (¶ [0054]), the controller (54, Fig. 1) configured to receive data from the one or more sensors and communicate the data to a processing device (140, Fig. 7) configured to use host software to process the data collected by the one or more sensors to determine one or more conditions associated with the wound (¶ [0058]).
Regarding Claim 51, Burgmann further discloses at least one of the controller (54, Fig. 1) and the processing device (140, Fig. 7) is configured to indicate, based on the one or more conditions associated with the wound, that the wound is healing (¶ [0054, 0059, 0060, 0065]; for example the program can output a graph showing the temperature of the wound over time which would indicate if an infection is present or a previous infection has healed).
Regarding Claim 52, Burgmann further discloses the controller (54, Fig. 1) is configured to wirelessly communicate with at least one of the one or more sensors and the processing device (140, Fig. 7; ¶ [0059]).
Regarding Claim 53, Burgmann further discloses the controller (54, Fig. 1) is configured to be in electrical communication with at least one of the one or more sensors and the processing device (140, Fig. 7) through electrical wiring (56, Fig. 1).
Regarding Claim 54, Burgmann further discloses the wound dressing (52, Fig. 1) comprises a wound contact layer (adhesive layer 80, Fig. 6) and the substantially flexible substrate (70, Figs. 2 and 6) is positioned on or in the wound contact layer (80, Fig. 6).
Regarding Claim 55, in an additional interpretation of Burgmann, Burgmann further discloses the wound contact layer (80 and 78, Fig. 6) comprises a first wound contact layer (80, Fig. 6) and a second wound contact layer (78, Fig. 6; the upper layer 78 can be considered a wound contact layer as the layer is in contact with the wound via the adhesive layer 80), wherein the substantially flexible substrate (70, Fig. 6) is sandwiched between the first and second wound contact layers (80 and 78, Fig. 6).
Regarding Claim 58, Burgmann further discloses an absorbent layer (72, Fig. 6) positioned over the wound contact layer (80, Fig. 6) and a backing layer (upper layer 78, Fig. 6) positioned over the wound contact layer (80, Fig. 6), wherein the wound contact layer (80, Fig. 6) is sealed to the backing layer (78, Fig. 6; ¶ [0051]).
Regarding Claim 60, Burgmann further discloses the wound dressing (52, Fig. 1) is included in a multi-layer wound dressing (as seen in Fig. 6) configured to treat the wound without the use of negative pressure (negative pressure is not provided by the dressing).
Regarding Claim 62, Burgmann further discloses a wound dressing (52, Fig. 1) comprising:
a sensor assembly (70, Fig. 2) comprising a plurality of sensors (108a, 108b, 108c, Fig. 3) arranged on a wound facing side (¶ [0054]), the sensor assembly (70, Fig. 2) being at least partly formed from a flexible material (¶ [0055]; the cables connecting the segments are flexible); and
a connector interface (56, Fig. 1) configured to connect the wound dressing (52, Fig. 1) to a control module (54, Fig. 1) configured to receive data from the sensor assembly (70, Fig. 2), the connector interface (56, Fig. 1) comprising a plurality of terminals configured to form electrical connections with respective terminals of the control module (54, Fig. 1; ¶ [0050]).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgmann (US 2012/0116485) in view of McChrystal et al (US 2014/0062462) further in view of Koetse et al (US 2013/0133822).
Regarding Claim 44, Burgmann/McChrystal is silent whether the plurality of linearly extending sensor array portions have different lengths and extend inward to different locations within an interior of the wound dressing.
Koetse teaches a substrate that can be used in a smart bandage (¶ [0030]), thus being in the same field of endeavor, with a plurality of linearly extending sensor array portions (tracks 3 ending in adhesive 4 to receive component 2, Figs 2-4; ¶ [000022, 0030]). One group of tracks has one length and the other group of tracks has a different length (as seen in Figs. 2 and 4) which allows the components to be placed at different locations along the interior of the substrate.
Therefore, it would have been obvious to modify the plurality of linearly extending sensor array portions of Burgmann/McChrystal to have different lengths and therefore extend inward to different locations within the interior of the wound dressing, as taught by Koetse, to vary the location of the sensor devices by varying the physical extension of the support holding the sensor.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgmann (US 2012/0116485) in view of McChrystal et al (US 2014/0062462) further in view of McAdams (US 2006/0270942).
Regarding Claim 45, Burgmann/McChrystal is silent whether the substantially flexible substrate is perforated to minimize blocking of fluid flow through the substantially flexible substrate.
McAdams teaches a wound dressing with sensors, thus being in the same field of endeavor, where the electrodes are printed on a flexible substrate (18, Fig. 7; ¶ [0058]), where the substrate is perforated to enhance flexibility and enable moisture to escape when necessary (¶ [0061]).
Therefore, it would have been obvious to modify the flexible substrate of Burgmann/McChrystal to be perforated to minimize blocking of fluid flow through the substantially flexible substrate, as taught by McAdams, to enable moisture to escape the dressing when necessary (as motivated by McAdams ¶ [0061]).
Claim(s) 56, 57, 59, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgmann (US 2012/0116485) in view of McChrystal et al (US 2014/0062462) further in view of Freedman et al (US 2014/0066868).
Regarding Claim 56, Burgmann/McChrystal is silent whether at least one of the one or more sensors is configured to be in direct contact with the wound.
Freedman discloses a wound dressing, thus being in the same field of endeavor, with one or more sensors configured to be in direct contact with the wound (¶ [0064]) to allow direct measurement of wound pressure rather than an indirect measurement obtained more distally from the wound (¶ [0064]).
Therefore, it would have been obvious to modify at least one of the one or more sensors of Burgmann/McChrystal to be in direct contact with the wound to allow direct measurement of the wound and therefore ensure an accurate measurement, as taught by Freedman (¶ [0064]).
Regarding Claim 57, Burgmann further discloses at least a second sensor configured to not contact the wound (temperature sensor 108a, Figs. 2 and 3 does not contact the wound).
Burgmann/McChrystal is silent whether at least one of the one or more sensors is configured to be in direct contact with the wound.
Freedman discloses a wound dressing, thus being in the same field of endeavor, with one or more sensors configured to be in direct contact with the wound (¶ [0064]) to allow direct measurement of wound pressure rather than an indirect measurement obtained more distally from the wound (¶ [0064]).
Therefore, it would have been obvious to modify at least one of the one or more sensors of Burgmann/McChrystal to be in direct contact with the wound to allow direct measurement of the wound and therefore ensure an accurate measurement, as taught by Freedman (¶ [0064]).
Regarding Claim 59, Burgmann/McChrystal is silent regarding a port on the backing layer, the port configured to connect the wound dressing to a source of negative pressure.
Freedman teaches a port (121, Fig. 1C) on the backing layer (113, Fig. 1C), the port (121, Fig. 1C) configured to connect the wound dressing (Fig. 1C) to a source of negative pressure (¶ [0067]). Negative pressure is well known in the art to facilitate the healing of wounds (¶ [0009]).
Therefore, it would have been obvious to modify the backing layer of Burgmann/McChrystal to include a port configured to connect the wound dressing to a source of negative pressure, as taught by Freedman. This allows the wound to heal more effectively as negative pressure is well known in the art to facilitate the healing of wounds (as motivated by Freedman ¶ [0009]).
Regarding Claim 61, Burgmann/McChrystal is silent regarding a negative pressure source configured to be in fluid communication with the wound dressing and further configured to apply negative pressure to the wound.
Freedman teaches a negative pressure source (107, Fig. 1A) configured to be in fluid communication with the wound dressing (Fig. 1A/1C) and further configured to apply negative pressure to the wound (¶ [0056, 0067]). Negative pressure is well known in the art to facilitate the healing of wounds (¶ [0009]).
Therefore, it would have been obvious to modify the backing layer of Burgmann/McChrystal to include a negative pressures source configured to be in fluid communication with the wound dressing and further configured to apply negative pressure to the wound, as taught by Freedman. This allows the wound to heal more effectively as negative pressure is well known in the art to facilitate the healing of wounds (as motivated by Freedman ¶ [0009]).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781