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 .
Applicant’s amendments and arguments filed in the reply on May 18, 2026 were received and fully considered. Claims 1-2, 8, and 17-20 were amended. Please see below for more detail.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “compare the optical data indicative of the wavelength of light with an alert threshold; and
determine an amount of blood received by the blood detection layer based upon the comparison between the optical data indicative of the wavelength of light and the alert threshold.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“an optical sensor comprising:
a light source configured to emit light; 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, wherein the optical data is indicative of at least a wavelength of the light;”
“receive the optical data generated by the optical receiver in response to the light emitted by the light source;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, permeable films, optical fibers, light sources, and optical receivers are general field of use and controllers are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of comparing the received optical data indicative of the wavelength of the light with an alert threshold and determining an amount of blood received by a blood detection layer based on the comparison and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-16 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 17, the claim(s) recites “comparing the optical data indicative of the wavelength of light with an alert threshold; and
determining an amount of blood received by the blood detection layer based upon the comparison between the optical data indicative of the wavelength of light and the alert threshold.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“emitting light from a light source to one or more optical fibers supported by a permeable film of a blood detection layer;
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, wherein the optical data is indicative of at least a wavelength of the emitted light”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, permeable films, optical fibers, light sources, and optical receivers are general field of use.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of comparing the received optical data indicative of the wavelength of the light with an alert threshold and determining an amount of blood received by a blood detection layer based on the comparison and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claim 18 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 19, the claim(s) recites “compare the optical data indicative of the wavelength of light with an alert threshold; and
determine an amount of blood received by the blood detection layer based upon the comparison between the optical data indicative of the wavelength of light and the alert threshold.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“emit light from a light source to one or more optical fibers supported by a permeable film of a blood detection layer;”
“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, wherein the optical data is indicative of at least a wavelength of the emitted light;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, permeable films, optical fibers, light sources, and optical receivers are general field of use and non-transitory computer-readable storage medium are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of comparing the received optical data indicative of the wavelength of the light with an alert threshold and determining an amount of blood received by a blood detection layer based on the comparison and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claim 20 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
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) 1-5, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll (US 2005/0038325) as noted in Applicant IDS dated 7/10/2023 in view of Park (KR 2022/0147875).
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
compare the optical data indicative of a light path altered by the physical presence of blood with an 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); and
determine an amount of blood received by the blood detection layer based upon the comparison between the optical data indicative of a light path altered by the physical presence of blood and the alert threshold ([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.”, [0070] “The sensor output is variable or progressive or regressive depending on the amount of liquid detected by the site sensor 180.”, [0074] indicating a variable output that reflects the amount of liquid, i.e. blood, detected that is also contextualized by the activation of an alarm condition for a certain threshold amount), their combined efforts fail to teach
the optical data indicative of a light path altered by the physical presence of blood is the wavelength of light.
However Park teaches an apparatus for sensing blood leak using optical fiber (p1, Abstract, Fig. 3, patch 300) comprising
a blood detection layer comprising:
An absorbent layer (Fig. 3, p3, absorbent layers 322 and 321);
One or more optical fibers supported by the absorbent layers (Fig. 3, optical fiber first part 110 and optical fiber second part 120);
An optical sensor comprising:
A light source configured to emit light (Figs. 1 and 3, p3, light generator 210 is connected to optical first part 110 to emit light through the optical fibers);
An optical receiver in optical communication with the light source via the one or more optical fibers (Figs. 1 and 3, p3, photodetector 220 is connected to optical fiber second part 120 to transmit light received in response to the light passing through the gap through the optical fibers);
Where the optical sensor output is evaluated by
Comparing the wavelength of light of the received optical data generated by the optical receiver in response to the light emitted by the light source to an alert threshold (p3, “Referring to FIG. 1 , a first alarm 230 is connected to the photodetector 220 . The first alarm 230 is to generate a first danger signal when the difference between the wavelength detected by the photodetector 220 and the wavelength of the light introduced to one end of the optical fiber 100 is out of a preset range. That is, the photodetector 220 compares the wavelength (color) of the light emitted from the other end of the optical fiber 100 and the light generated through the light generator 210 so that the difference in wavelength (color) is outside the preset range. When it is determined, a signal is transmitted to the first alarm 230 so that the first alarm 230 generates a first danger signal.”);
determining that the amount of blood received by the blood detection layer indicates an alert condition based on the comparison between the optical data and the wavelength of light alert threshold (p3, “Referring to FIG. 1 , a first alarm 230 is connected to the photodetector 220 . The first alarm 230 is to generate a first danger signal when the difference between the wavelength detected by the photodetector 220 and the wavelength of the light introduced to one end of the optical fiber 100 is out of a preset range. That is, the photodetector 220 compares the wavelength (color) of the light emitted from the other end of the optical fiber 100 and the light generated through the light generator 210 so that the difference in wavelength (color) is outside the preset range. When it is determined, a signal is transmitted to the first alarm 230 so that the first alarm 230 generates a first danger signal.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to evaluate an altered light path by the physical presence of blood as taught in Moll specifically by measuring wavelengths of light as taught by Park as the providing of a specific teaching (Park’s wavelength) to accomplish the broad teaching set in Moll. Furthermore, this will provide a standardization across applications of the invention, by setting how the altered light path will be evaluated, thus ensuring a greater consistency in results.
Regarding Claim 2, Moll and Park teach the sensing device according to Claim 1, and Moll teaches wherein the controller is further configured to:
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 and Park teach 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 and Park teach the sensing device according to Claim 2, and Moll further teaches 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 and Park teach 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 17, while 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
comparing the optical data indicative of a light path altered by the physical presence of blood with an 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); and
determining an amount of blood received by the blood detection layer based upon the comparison between the optical data indicative of a light path altered by the physical presence of blood and the alert threshold ([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.”, [0070] “The sensor output is variable or progressive or regressive depending on the amount of liquid detected by the site sensor 180.”, [0074] indicating a variable output that reflects the amount of liquid, i.e. blood, detected that is also contextualized by the activation of an alarm condition for a certain threshold amount), their combined efforts fail to teach
the optical data indicative of a light path altered by the physical presence of blood is the wavelength of light.
However Park teaches an apparatus for sensing blood leak using optical fiber (p1, Abstract, Fig. 3, patch 300) comprising
a blood detection layer comprising:
An absorbent layer (Fig. 3, p3, absorbent layers 322 and 321);
One or more optical fibers supported by the absorbent layers (Fig. 3, optical fiber first part 110 and optical fiber second part 120);
An optical sensor comprising:
A light source configured to emit light (Figs. 1 and 3, p3, light generator 210 is connected to optical first part 110 to emit light through the optical fibers);
An optical receiver in optical communication with the light source via the one or more optical fibers (Figs. 1 and 3, p3, photodetector 220 is connected to optical fiber second part 120 to transmit light received in response to the light passing through the gap through the optical fibers);
Where the optical sensor output is evaluated by
Comparing the wavelength of light of the received optical data generated by the optical receiver in response to the light emitted by the light source to an alert threshold (p3, “Referring to FIG. 1 , a first alarm 230 is connected to the photodetector 220 . The first alarm 230 is to generate a first danger signal when the difference between the wavelength detected by the photodetector 220 and the wavelength of the light introduced to one end of the optical fiber 100 is out of a preset range. That is, the photodetector 220 compares the wavelength (color) of the light emitted from the other end of the optical fiber 100 and the light generated through the light generator 210 so that the difference in wavelength (color) is outside the preset range. When it is determined, a signal is transmitted to the first alarm 230 so that the first alarm 230 generates a first danger signal.”);
determining that the amount of blood received by the blood detection layer indicates an alert condition based on the comparison between the optical data and the wavelength of light alert threshold (p3, “Referring to FIG. 1 , a first alarm 230 is connected to the photodetector 220 . The first alarm 230 is to generate a first danger signal when the difference between the wavelength detected by the photodetector 220 and the wavelength of the light introduced to one end of the optical fiber 100 is out of a preset range. That is, the photodetector 220 compares the wavelength (color) of the light emitted from the other end of the optical fiber 100 and the light generated through the light generator 210 so that the difference in wavelength (color) is outside the preset range. When it is determined, a signal is transmitted to the first alarm 230 so that the first alarm 230 generates a first danger signal.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to evaluate an altered light path by the physical presence of blood as taught in Moll specifically by measuring wavelengths of light as taught by Park as the providing of a specific teaching (Park’s wavelength) to accomplish the broad teaching set in Moll. Furthermore, this will provide a standardization across applications of the invention, by setting how the altered light path will be evaluated, thus ensuring a greater consistency in results.
Regarding Claim 18, Moll and Park teach the method according to Claim 17, wherein determining the amount of blood further comprises:
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, while 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
compare the optical data indicative of a light path altered by the physical presence of blood with an 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); and
determine an amount of blood received by the blood detection layer based upon the the comparison between the optical data indicative of a light path altered by the physical presence of blood and the alert threshold ([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.”, [0070] “The sensor output is variable or progressive or regressive depending on the amount of liquid detected by the site sensor 180.”, [0074] indicating a variable output that reflects the amount of liquid, i.e. blood, detected that is also contextualized by the activation of an alarm condition for a certain threshold amount), their combined efforts fail to teach
the optical data indicative of a light path altered by the physical presence of blood is the wavelength of light.
However Park teaches an apparatus for sensing blood leak using optical fiber (p1, Abstract, Fig. 3, patch 300) comprising
a blood detection layer comprising:
An absorbent layer (Fig. 3, p3, absorbent layers 322 and 321);
One or more optical fibers supported by the absorbent layers (Fig. 3, optical fiber first part 110 and optical fiber second part 120);
An optical sensor comprising:
A light source configured to emit light (Figs. 1 and 3, p3, light generator 210 is connected to optical first part 110 to emit light through the optical fibers);
An optical receiver in optical communication with the light source via the one or more optical fibers (Figs. 1 and 3, p3, photodetector 220 is connected to optical fiber second part 120 to transmit light received in response to the light passing through the gap through the optical fibers);
Where the optical sensor output is evaluated by
Comparing the wavelength of light of the received optical data generated by the optical receiver in response to the light emitted by the light source to an alert threshold (p3, “Referring to FIG. 1 , a first alarm 230 is connected to the photodetector 220 . The first alarm 230 is to generate a first danger signal when the difference between the wavelength detected by the photodetector 220 and the wavelength of the light introduced to one end of the optical fiber 100 is out of a preset range. That is, the photodetector 220 compares the wavelength (color) of the light emitted from the other end of the optical fiber 100 and the light generated through the light generator 210 so that the difference in wavelength (color) is outside the preset range. When it is determined, a signal is transmitted to the first alarm 230 so that the first alarm 230 generates a first danger signal.”);
determining that the amount of blood received by the blood detection layer indicates an alert condition based on the comparison between the optical data and the wavelength of light alert threshold (p3, “Referring to FIG. 1 , a first alarm 230 is connected to the photodetector 220 . The first alarm 230 is to generate a first danger signal when the difference between the wavelength detected by the photodetector 220 and the wavelength of the light introduced to one end of the optical fiber 100 is out of a preset range. That is, the photodetector 220 compares the wavelength (color) of the light emitted from the other end of the optical fiber 100 and the light generated through the light generator 210 so that the difference in wavelength (color) is outside the preset range. When it is determined, a signal is transmitted to the first alarm 230 so that the first alarm 230 generates a first danger signal.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to evaluate an altered light path by the physical presence of blood as taught in Moll specifically by measuring wavelengths of light as taught by Park as the providing of a specific teaching (Park’s wavelength) to accomplish the broad teaching set in Moll. Furthermore, this will provide a standardization across applications of the invention, by setting how the altered light path will be evaluated, thus ensuring a greater consistency in results.
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:
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(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Park and further in view of Hyde et al (US 2009/0112295) (“Hyde”).
Regarding Claim 6, while Moll and Park teach the sensing device according to Claim 5, their combined efforts fail 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, Park, 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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Park and further in view of Rabinovitz et al (WO 2014/102791) (“Rabinovitz”).
Regarding Claim 8, while Moll and Park teach the sensing device according to Claim 5, further comprising a first diversion layer, the 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), their combined efforts fail to teach the first diversion layer is configured to facilitate uniform distribution of blood along a surface area of the blood detection layer by slowing a flow of blood.
However Rabinovitz teaches a optical-detection system for the presence of blood (Abstract, [0019]) where the optical detection system may comprise a diversion layer configured to slow a flow of blood through the system ([0020] membrane or filter blocks other components from entering the device and slows down flow, but the slowed flow may provide higher sensitivitry).
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 diversion layer with a slowing characteristic of Rabinovitz to be incorporated into the diversion layer of Moll as Rabinovitz teaches that a filtering component of fluid will reduce noise and therefore increase sensitivity. Further, as written be applicant, by slowing the flow of blood in Moll, the uniform distribution of blood will naturally occur.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Park and further in view of Rabinovitz and further in view of Bogner et al (US 2005/0099294) (“Bogner”).
Regarding Claim 9, while Moll, Park, and Rabinovitz teach 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]). Furthermore, such a fabric can direct fluid to a slowing filter of Rabinovitz to increase accuracy of system.
Regarding Claim 12, Moll, Park, Rabinovitz, 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 Park and further in view of Rabinovitz and further in view of Engvall (US 2008/249487) as noted in Applicant IDS dated 7/10/2023.
Regarding Claim 10, while Moll, Park, and Rabinovitz teach the sensing device according to Claim 8, their combined efforts fail 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, Park, and Rabinovitz 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, Park, Rabinovitz, 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 Park and further in view of Rabinovitz and further in view of Engvall and further in view of Oden et al (US 2015/0025349) (“Oden”).
Regarding Claim 11, while Moll, Park, Rabinovitz, 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 Park and further in view of Rabinovitz and further in view of Engvall and further in view of Bogner.
Regarding Claim 14, while Moll, Park, Rabinovitz, 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]). Furthermore, such a fabric can direct fluid to a slowing filter of Rabinovitz to increase accuracy of system.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moll in view of Park and further in view of Rabinovitz and further in view of Bogner and further in view of Hyde.
Regarding Claim 15, while Moll, Park, Rabinovitz, 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 Park and further in view of Rabinovitz and further 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, Park, Rabinovitz, 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, Park, Rabinovitz, Bogner, 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.
Response to Arguments
Applicant’s amendments and arguments filed 5/18/2026 with respect to the 35 USC 102(a)(1) rejections of Claims 1, 17, and 19 have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Moll and Park.
Consequently, Claims 2-16, 18, and 20 remain rejected due to their dependency on rejected independent claims 1, 17, and 19.
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.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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