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 § 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.
Claims 1-5, 8, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moll (US 2005/0038325) as noted in Applicant IDS dated 7/10/2023.
Regarding Claim 1, while Moll teaches a sensing device for hemorrhage detection (Abstract, [0018]), the device comprising:
a blood detection layer comprising:
a permeable film (Fig. 4, [0054] base membrane layer 210 is permeable by way of multiple holes 260); and
one or more optical fibers supported by the permeable film (Fig. 4, [0055] base membrane layer 210 supports site sensor 180, Fig. 10, [0082] where site sensor 180 can include optical fibers 370);
an optical sensor comprising:
a light source configured to emit light ([0082] light source); and
an optical receiver in optical communication with the light source via the one or more optical fibers, the optical receiver configured to generate optical data responsive to the light emitted by the light source and received by the optical receiver via the one or more optical fibers ([0082] analytical circuit in optical communication with the light source via the one or more optical fibers 370, the optical receiver configured to generate optical data responsive to the light emitted by the light source and received by the optical receiver via the one or more optical fibers), wherein the optical data is indicative of at least a wavelength of the light (Examiner notes that optical data will necessarily be indicative of a wavelength of light); and
a controller operably coupled with the optical sensor ([0066] the site sensor 180 is controlled by a controller), wherein the controller is configured to:
receive the optical data generated by the optical receiver in response to the light emitted by the light source ([0082]); and
determine an amount of blood received by the blood detection layer based upon the optical data ([0068], [0070], [0074]).
Regarding Claim 2, Moll teaches the sensing device according to Claim 1, wherein the controller is further configured to:
compare the optical data with an alert threshold; and
generate an alert signal in an instance in which the optical data satisfies the alert threshold ([0082] “In another embodiment, a light path may be altered by the physical presence of blood or liquid in the space between layers, altering an optical picture, which is detected by the analytical circuit 190 and sets off the alarm.” [0068] “The site sensor 180 utilizes the separation or spacers between the various layers of the site sensor 180 to control or calibrate the amount of blood or fluid required to activate an alarm condition.” An amount requirement reflects threshold).
Regarding Claim 3, Moll teaches the sensing device according to Claim 2, wherein the alert signal is configured to cause presentation of a user notification ([0073]-[0074] enunciator output of display is a presentation of a user notification, where the enunciator outputs alarms).
Regarding Claim 4, Moll teaches the sensing device according to Claim 2, wherein the alert signal is configured to modify an operating condition of one or more systems communicably coupled with the controller ([0070] alert signal is configured to modify an operating condition of one or more systems communicably coupled with the controller as the output is recognized as including electrochemical changes and mechanical force actuations
Regarding Claim 5, Moll teaches the sensing device according to Claim 1, wherein the one or more optical fibers are supported by a first surface of the permeable film (See Claim 1 Rejection, top surface of membrane layer 210 is the supporting first surface for the optical fibers).
Regarding Claim 8, Moll teaches the sensing device according to Claim 5, further comprising a first diversion layer defining a first surface and a second surface opposite the first surface, wherein the second surface of the first diversion layer is applied to the first surface of the blood detection layer (Fig. 4, [0051] first diversion layer / second membrane layer 220 applied to a first surface of a sensing array 240).
Regarding Claim 17, Moll teaches a method for hemorrhage detection, the method comprising:
emitting light from a light source to one or more optical fibers supported by a permeable film of a blood detection layer (Fig. 4, [0055] base membrane layer 210 supports site sensor 180, Fig. 10, [0082] light source emits light to one or more optical fibers 370, where the optical fiber act as the supported site sensor over base membrane layer 210);
generating, by an optical receiver in optical communication with the light source via the one or more optical fibers, optical data responsive to the light emitted by the light source ([0082] analytical circuit in optical communication with the light source via the one or more optical fibers 370, the optical receiver configured to generate optical data responsive to the light emitted by the light source and received by the optical receiver via the one or more optical fibers), wherein the optical data is indicative of at least a wavelength of the light (Examiner notes that optical data will necessarily be indicative of a wavelength of light); and
determining an amount of blood received by a blood detection layer based upon the optical data ([0068], [0070], [0074]).
Regarding Claim 18, Moll teaches the method according to Claim 17, wherein determining the amount of blood further comprises:
comparing the optical data with an alert threshold; and
generating an alert signal in an instance in which the optical data satisfies the alert threshold ([0082] “In another embodiment, a light path may be altered by the physical presence of blood or liquid in the space between layers, altering an optical picture, which is detected by the analytical circuit 190 and sets off the alarm.” [0068] “The site sensor 180 utilizes the separation or spacers between the various layers of the site sensor 180 to control or calibrate the amount of blood or fluid required to activate an alarm condition.” An amount requirement reflects threshold).
Regarding Claim 19, Moll teaches a computer program product for hemorrhage detection, the computer program product comprising at least one non-transitory computer-readable storage medium storing program instructions that, when executed, cause a system to:
emit light from a light source to one or more optical fibers supported by a permeable film of a blood detection layer (Fig. 4, [0055] base membrane layer 210 supports site sensor 180, Fig. 10, [0082] light source emits light to one or more optical fibers 370, where the optical fiber act as the supported site sensor over base membrane layer 210);
generate, by an optical receiver in optical communication with the light source via the one or more optical fibers, optical data responsive to the light emitted by the light source ([0082] analytical circuit in optical communication with the light source via the one or more optical fibers 370, the optical receiver configured to generate optical data responsive to the light emitted by the light source and received by the optical receiver via the one or more optical fibers), wherein the optical data is indicative of at least a wavelength of the light (Examiner notes that optical data will necessarily be indicative of a wavelength of light); and; and
determine an amount of blood received by a blood detection layer based upon the optical data ([0068], [0070], [0074]).
Regarding Claim 20, Moll teaches the computer program product according to Claim 19, the computer program product comprising at least one non-transitory computer-readable storage medium storing program instructions that, when executed, further cause the system to:
compare the optical data with an alert threshold; and
generate an alert signal in an instance in which the optical data satisfies the alert threshold ([0082] “In another embodiment, a light path may be altered by the physical presence of blood or liquid in the space between layers, altering an optical picture, which is detected by the analytical circuit 190 and sets off the alarm.” [0068] “The site sensor 180 utilizes the separation or spacers between the various layers of the site sensor 180 to control or calibrate the amount of blood or fluid required to activate an alarm condition.” An amount requirement reflects threshold).
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.
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Hyde et al (US 2009/0112295) (“Hyde”).
Regarding Claim 6, while Moll teaches the sensing device according to Claim 5, Moll fails to teach the sensing device further comprising an anti-penetration layer applied to a second surface of the permeable film, wherein the second surface is opposite the first surface.
However Hyde teaches a patch system for collecting patient fluid (Abstract) comprising polyethylene film backing sheets ([0094]-[0096] where these backing sheets can be vapor permeable and fluid impermeable to facilitate a sealing of liquid sample) and further teaches the backing sheet can also act as an adhesive applied to the surface of an individual.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have an adhesive backing sheet as taught by Hyde for the adhering component of Moll as this enables the fluid facilitation properties of these backing sheets to be utilized to draw fluid within Moll’s patch. Furthermore, this will provide a standardization across applications of the invention, thus ensuring a greater consistency in results.
Regarding Claim 7, Moll and Hyde teach the sensing device according to Claim 6, wherein the anti-penetration layer comprises a polyethylene (PE) or polypropylene (PP) porous film configured to emit vapor to an external environment of the sensing device but preclude fluid transmission therethrough (See Claim 6 Rejection, polyethylene porous film is configured to emit vapor to an external environment of the sensing device but preclude fluid transmission therethrough) and Moll teaches that the pores in the films may be any desired size ([0068] thus encompassing a micro scale for the pores).
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Bogner et al (US 2005/0099294) (“Bogner”).
Regarding Claim 9, while Moll teaches the sensing device according to Claim 8, Moll fails to teach wherein the first diversion layer comprises an air through non-woven of polyethylene (PE) and polyethylene terephthalate (PET) bicomponent fibers or PE and polypropylene (PP) bicomponent fibers.
However Bogner teaches a worn fabric for interacting with and guiding patient fluid (Abstract, [0034]) wherein a mesh layer comprises a layer of non-woven polyethylene (PE) and polypropylene (PP) ([0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the second membrane layer of Moll comprise air through non-woven of PE and polypropylene (PP) bicomponent fibers as Bogner teaches such a fabric layer is suitable for medical fluid collecting and provides suitable flexibility for wearing ([0034]).
Regarding Claim 12 while Moll and Bogner teach the sensing device according to Claim 9, wherein one or more bicomponent fibers of the first diversion layer are arranged along a lengthwise direction of the first diversion layer (See Claim 9 Rejection¸ Bogner teaches the layers as a mesh, indicating biocomponent fibers arranged both in a lengthwise and widthwise direction).
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Engvall (US 2008/249487) as noted in Applicant IDS dated 7/10/2023.
Regarding Claim 10, while Moll teaches the sensing device according to Claim 8, Moll fails to teach the sensing device further comprising an absorption layer defining a first surface and a second surface opposite the first surface, wherein the second surface of the absorption layer is applied to the first surface of the first diversion layer.
However Engvall teaches a blood leakage detection device (Abstract) comprising an absorbent layer applied over an optical fiber sensing layer (Figs. 3 and 4, absorbent patch 10 applied over blood detection optical fibers 5a, 5b, 5c, and permeable film / blood passage element 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the second membrane layer of Moll include an above absorbent layer as taught by Engvall to provide a blood collection feature by absorbent layer, as this provides a clearer and more sanitary environment around a subject wound.
Regarding Claim 13, while Moll and Engvall teach the sensing device according to Claim 10, further comprising a second diversion layer defining a first surface and a second surface opposite the first surface (Fig. 4, [0051] second diversion layer / third membrane layer 230 applied over the first diversion layer and another sensing layer and a back surface of the patch system), their combined efforts fail to teach wherein the second surface of the second diversion layer is applied to the first surface of the absorption layer.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the third membrane layer of Moll be above the absorbent layer taught by Moll and Engvall so that it may continue to apply its sealing functionality (Moll: [0060]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Engvall and further in view of Oden et al (US 2015/0025349) (“Oden”).
Regarding Claim 11, while Moll and Engvall teach the sensing device according to Claim 10, Moll fails to teach wherein the absorption layer comprises a superabsorbent polymer (SAP).
However Oden teaches a blood leakage detection device (Abstract) comprising an absorbent layer that is a superabsorbent polymer ([0005], [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the absorbent layer of Moll and Engvall be a super absorbent polymer layer as taught by Oden as a way to provide standardized construction for a blood leakage absorbing layer, ensuring consistency of results across applications of the invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Engvall and further in view of Bogner.
Regarding Claim 14, while Moll and Engvall teach the sensing device according to Claim 13, their combined efforts fail to teach wherein the second diversion layer comprises an air through non-woven of polyethylene (PE) and polyethylene terephthalate (PET) bicomponent fibers or PE and polypropylene (PP) bicomponent fibers.
However Bogner teaches a worn fabric for interacting with and guiding patient fluid (Abstract, [0034]) wherein a mesh layer comprises a layer of non-woven polyethylene (PE) and polypropylene (PP) ([0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the third membrane layer of Moll comprise air through non-woven of PE and polypropylene (PP) bicomponent fibers as Bogner teaches such a fabric layer is suitable for medical fluid collecting and provides suitable flexibility for wearing ([0034]) and may utilize the non-porous construction in Moll to retain its sealing properties ([0060]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Bogner and further in view of Hyde.
Regarding Claim 15, while Moll and Bogner teach the sensing device according to Claim 13, and Moll teaches the system can use a hydrophobic layer ([0068]), their combined efforts fail to teach the system further comprising a hydrophobic layer defining a first surface and a second surface opposite the first surface, wherein the second surface of the hydrophobic layer is applied to the first surface of the second diversion layer.
However Hyde teaches a patch system for collecting patient fluid (Abstract) comprising hydrophobic film backing sheets at the top of the patch ([0106] where these backing sheets can be vapor permeable and fluid impermeable to facilitate a sealing of liquid sample).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have a hydrophobic top backing sheet as taught by Hyde for the system of Moll as this ensure no fluid is entering from the outside and contaminating the fluid guiding and sealing components within the system of Moll.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Bogner and further in view of Hyde and further in view of Teixeira et al (US 2012/0095369) (“Teixeira”).
Regarding Claim 16, while Moll, Bogner, and Hyde teach the sensing device according to Claim 15, their combined efforts fail to teach wherein the hydrophobic layer comprises a spunbond nonwoven material or an air through non-woven polyethylene (PE) or polypropylene (PP) material.
However Teixeira teaches a fluid sampling system (Abstract, [0050]) with a hydrophobic layer comprising a spunbond nonwoven material or an air through non-woven polyethylene (PE) or polypropylene (PP) material ([0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the hydrophobic layer of Moll and Hyde comprise a spunbond nonwoven material or an air through non-woven polyethylene (PE) or polypropylene (PP) material as taught by Teixeira as a way to provide standardized fabric construction for a hydrophobic layer, ensuring consistency of results across applications of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791