DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 05/11/2026 has been entered. Claims 88 - 98, 100 - 103, 105 - 110 and 113 - 114 are pending. Claims 99, 104, 111, and 112 are cancelled.
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 100 - 105 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.
In regard to claim 100, lines 5 - 6 recites, “a cutter configured to move into a position… upon actuation by the actuator…” However, “the actuator” lacks antecedent basis. Claims 101- 103 and 105 are rejected by virtue of dependence on claims 100.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 88 - 93, 97, 100 - 103, 106 - 108, & 110 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant).
In regard to claim 88, Escutia discloses a device for application to a subject's skin, comprising:
a reversibly deformable structure that moves between a first configuration and a second configuration upon actuation of the device; Escutia discloses that the actuation element (FIG. 7, component 40) is a mechanical spring (paragraph [0068]). One of ordinary skill in the art would recognize that a spring is a reversibly deformable structure that would move from one configuration to another upon actuation by the actuator.
a cutter configured to move into a position insertable into the skin of the subject upon actuation of the device; Escutia discloses a skin penetration member that acts as a cutter, where the skin penetration member is actuated or driven into the surface of the skin (paragraph [0086]).
and a device interface configured to engage with a detachable portion configured to receive a fluid released from the skin of the subject by the cutter, the detachable portion comprising an interface engageable with an external apparatus. Escutia discloses that the device includes an assay pad (FIG. 1, component 38) that is used to collect the sample of body fluid. The assay pad can be removed or detached from the sample collecting device and inserted into an external apparatus such as an electrochemical or photometric meter (paragraph [0067]).
While Escutia discloses a device interface configured to engage with a detachable portion configured to receive a fluid released from the skin of the subject by the cutter, they do not specify that the detachable portion comprises a fluid storage chamber.
However, Emery teaches a device and method for sampling a body fluid using a device comprising at least one analyte quantification member (paragraph [0013]; FIG. 3, component 24) further comprising a fluid storage chamber or hub (FIG. 4, component 25) with a reagent pad (FIG. 4, component 26; paragraph [0067]) configured to receive a fluid released from the skin of the subject. Emery further teaches that the analyte quantification member (FIG. 3, component 24) is removed from the device (paragraph [0045]) such that the analyte quantification member comprising the fluid storage chamber (FIG. 4, component 25) and reagent pad (FIG. 4, component 26; paragraph [0067]) can be removed or detached from the device and inserted into an electrochemical or photometric meter to quantify an analyte level (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art to have modified the device disclosed by Escutia, which includes a detachable portion in the form of an assay pad that can be detached from the sample collecting device and inserted into an external apparatus (paragraph [0067]), with the teaching of Emery that a sampling device can include a detachable portion comprising a fluid storage chamber and connected assay pad (FIG. 4, components 25 & 26; paragraph [0067]) inserted into an external apparatus (paragraph [0045]), because Escutia already discusses the use of a detachable assay pad for analyte detection such that modifying Escutia with the teachings of Emery would be considered combining prior art elements, in this case the sampling device including a detachable assay pad as disclosed by Escutia with the teaching of Emery that a detachable portion of the device includes a fluid storage chamber containing an assay pad (FIG. 4, components 25 & 26; paragraph [0067]), to yield the predictable result of collecting a fluid released from the skin of a subject and analyzing the fluid for at least one analyte by detaching the detachable portion of the device for measurement with an external sensor.
In regard to claim 89, Escutia as modified discloses the invention of claim 88, further comprising the detachable portion and an external apparatus configured to engage with the detachable portion wherein the external apparatus comprises a sensor for determining an analyte. Escutia further discloses that the external apparatus includes an electrochemical or photometric meter to analyze the fluid sample collected on the analysis pad (paragraph [0067]) where the analysis pad (FIG. 1, component 38) comprises a reagent that changes color upon reaction with a target analyte which can be analyzed using the external apparatus (paragraph [0067]).
In regard to claim 90, Escutia as modified discloses the invention of claim 89, wherein the sensor is a pH sensor, an optical sensor, an ion sensor, or a colorimetric sensor. Escutia further discloses that the sensor can include an electrochemical or photometric sensor (paragraph [0067]). One of ordinary skill in the art would recognize that an electrochemical sensor could comprise a pH or ion sensor and that a photometric sensor comprises an optical sensor (paragraph [0086]).
In regard to claim 92, Escutia as modified discloses the invention of claim 88, wherein the cutter comprises a needle. Escutia discloses that the skin penetration member (FIG. 1, component 34) can take any suitable form including a needle (paragraph [0065]).
In regard to claim 93, Escutia as modified discloses the invention of claim 88, wherein the cutter comprises a microneedle. Escutia discloses that the skin penetration member (FIG. 1, component 34) can take any suitable form including a microneedle (paragraph [0066]).
In regard to claim 97, Escutia as modified discloses the invention of claim 88, wherein the device comprises a vacuum source that is configured to create a vacuum upon actuation of the device. Escutia discloses that the device includes a catalyst that is applied to the sampling site where the catalyst includes vacuum pressure generated by any suitable mechanism such as a pump (paragraph [0086]). The vacuum source is applied during or after penetration of the surface of the skin when the skin penetration member is actuated into the skin (paragraph [0086]). Escutia further discloses that the system can be programmed such that the actuation of the vacuum and skin penetration member are activated by the user pressing a button that acts as an actuator to initiate the collection of bodily fluid (paragraph [0070]).
In regard to claim 100, Escutia discloses a device for application to a subject's skin, comprising:
a mechanical structure configured to create a vacuum within the device upon actuation of the device; Escutia further discloses that the device includes a catalyst that is applied to the sampling site where the catalyst includes vacuum pressure generated by any suitable mechanism such as a pump (paragraph [0086]).
a cutter configured to move into a position insertable into the skin of the subject upon actuation by the actuator; Escutia discloses a skin penetration member that acts as a cutter, where the skin penetration member is actuated or driven into the surface of the skin (paragraph [0086]).
and an interface configured to engage with a detachable portion. Escutia discloses that the device includes an assay pad (FIG. 1, component 38) that is used to collect the sample of body fluid. The assay pad can be removed or detached from the sample collecting device and inserted into an external apparatus such as an electrochemical or photometric meter (paragraph [0067]).
While Escutia discloses a device interface configured to engage with a detachable portion configured to receive a fluid released from the skin of the subject by the cutter, they do not specify that the detachable portion comprises a fluid storage chamber.
However, Emery teaches a device and method for sampling a body fluid using a device comprising at least one analyte quantification member (paragraph [0013]; FIG. 3, component 24) further comprising a fluid storage chamber or hub (FIG. 4, component 25) with a reagent pad (FIG. 4, component 26; paragraph [0067]) configured to receive a fluid released from the skin of the subject. Emery further teaches that the analyte quantification member (FIG. 3, component 24) is removed from the device (paragraph [0045]) such that the analyte quantification member comprising the fluid storage chamber (FIG. 4, component 25) and reagent pad (FIG. 4, component 26; paragraph [0067]) can be removed or detached from the device and inserted into an electrochemical or photometric meter to quantify an analyte level (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art to have modified the device disclosed by Escutia, which includes a detachable portion in the form of an assay pad that can be detached from the sample collecting device and inserted into an external apparatus (paragraph [0067]), with the teaching of Emery that a sampling device can include a detachable portion comprising a fluid storage chamber and connected assay pad (FIG. 4, components 25 & 26; paragraph [0067]) inserted into an external apparatus (paragraph [0045]), because Escutia already discusses the use of a detachable assay pad for analyte detection such that modifying Escutia with the teachings of Emery would be considered combining prior art elements, in this case the sampling device including a detachable assay pad as disclosed by Escutia with the teaching of Emery that a detachable portion of the device includes a fluid storage chamber containing an assay pad (FIG. 4, components 25 & 26; paragraph [0067]), to yield the predictable result of collecting a fluid released from the skin of a subject and analyzing the fluid for at least one analyte by detaching the detachable portion of the device for measurement with an external sensor.
In regard to claim 101, Escutia as modified discloses the invention as set forth for claim 100, further comprising the detachable portion and an external apparatus configured to engage with the detachable portion, wherein the external apparatus comprises one or more sensors for determining an analyte. Escutia further discloses that the external apparatus includes an electrochemical or photometric meter (paragraph [0067]).
In regard to claim 102, Escutia as modified discloses the invention as set forth for claim 100, wherein the cutter comprises a needle. Escutia discloses that the skin penetration member (FIG. 1, component 34) comprises any suitable form, including a needle or microneedle (paragraph [0086]).
In regard to claim 103, Escutia as modified discloses the invention as set forth for claim 100 wherein the mechanical structure has a concave shape in a first configuration. Escutia discloses a structure that makes up the device-skin interface (FIG. 19 - 21) that is concave (FIG. 19 - 21, component 624).
In regard to claim 106, Escutia discloses a method comprising:
removing a detachable portion from a device, the device comprising a mechanical structure configured to create a vacuum within the device upon actuation of the device, and a cutter configured to move into a position insertable into the skin of a subject upon actuation of the device, wherein the detachable portion contains blood released from the skin of the subject by the cutter; Escutia discloses a method for collecting blood (paragraph [0086]) that includes removing a detachable portion, in this case an assay pad (FIG. 1, component 38) that is in fluid communication with the sample of body fluid (paragraph [0067]), where the assay pad can be removed from the device (FIG. 1, component 10) and inserted into a separate device for analysis of the collected body fluid. The device (FIG. 1, component 10) disclosed by Escutia includes an actuator comprising a button (paragraph [0070]) where a skin penetration member or cutter (FIG. 1, component 34) is connected to an actuator element (FIG. 1, component 40) such that the actuator element drives the skin penetration member into the skin at a sampling site (paragraph [0068]). Escutia further discloses that the device includes a catalyst that is applied to the sampling site where the catalyst includes vacuum pressure generated by any suitable mechanism such as a pump before, during, and/or after penetrating the skin (paragraph [0086]). Escutia additionally discloses that a user can begin the process of collecting a body fluid sample by initiating the process and pressing a button (paragraph [0070]).
and engaging the detachable portion with an external apparatus. Escutia discloses that the device includes an assay pad (FIG. 1, component 38) that is used to collect the sample of body fluid. The assay pad can be removed or detached from the sample collecting device and inserted into an external apparatus such as an electrochemical or photometric meter (paragraph [0067]).
While Escutia discloses a device interface configured to engage with a detachable portion configured to receive a fluid released from the skin of the subject by the cutter, they do not specify that the detachable portion comprises a fluid storage chamber.
However, Emery teaches a device and method for sampling a body fluid using a device comprising at least one analyte quantification member (paragraph [0013]; FIG. 3, component 24) further comprising a fluid storage chamber or hub (FIG. 4, component 25) with a reagent pad (FIG. 4, component 26; paragraph [0067]) configured to receive a fluid released from the skin of the subject. Emery further teaches that the analyte quantification member (FIG. 3, component 24) is removed from the device (paragraph [0045]) such that the analyte quantification member comprising the fluid storage chamber (FIG. 4, component 25) and reagent pad (FIG. 4, component 26; paragraph [0067]) can be removed or detached from the device and inserted into an electrochemical or photometric meter to quantify an analyte level (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art to have modified the device disclosed by Escutia, which includes a detachable portion in the form of an assay pad that can be detached from the sample collecting device and inserted into an external apparatus (paragraph [0067]), with the teaching of Emery that a sampling device can include a detachable portion comprising a fluid storage chamber and connected assay pad (FIG. 4, components 25 & 26; paragraph [0067]) inserted into an external apparatus (paragraph [0045]), because Escutia already discusses the use of a detachable assay pad for analyte detection such that modifying Escutia with the teachings of Emery would be considered combining prior art elements, in this case the sampling device including a detachable assay pad as disclosed by Escutia with the teaching of Emery that a detachable portion of the device includes a fluid storage chamber containing an assay pad (FIG. 4, components 25 & 26; paragraph [0067]), to yield the predictable result of collecting a fluid released from the skin of a subject and analyzing the fluid for at least one analyte by detaching the detachable portion of the device for measurement with an external sensor.
In regard to claim 107, Escutia as modified discloses the invention as set forth for claim 106, further comprising determining an analyte suspected of being present within the blood with one or more sensors of the external apparatus. Escutia discloses that the external apparatus includes an electrochemical or photometric meter to analyze the fluid sample collected on the analysis pad (paragraph [0067]). The analysis pad (FIG. 1, component 38) comprises a reagent that changes color upon reaction with a target analyte which can be analyzed using the external apparatus (paragraph [0067]).
In regard to claim 108, Escutia as modified discloses the invention as set forth for claim 106, further comprising moving a reversibly deformable structure of the mechanical structure between a first configuration and a second configuration upon actuation by the actuator. Escutia discloses that the actuation element (FIG. 7, component 40) is a mechanical spring (paragraph [0068]). One of ordinary skill in the art would recognize that a spring is a reversibly deformable structure that would move from one configuration to another upon actuation by the actuator.
In regard to claim 110, Escutia as modified discloses the invention as set forth for claim 106, further comprising determining an analyte present within the blood within the detachable portion. Escutia discloses that the device includes an assay pad (FIG. 1, component 38) that is used to collect the sample of body fluid. The assay pad can be removed or detached from the sample collecting device and inserted into an external apparatus such as an electrochemical or photometric meter (paragraph [0067]) to analyze the fluid sample collected on the analysis pad (paragraph [0067]). The analysis pad (FIG. 1, component 38) comprises a reagent that changes color upon reaction with a target analyte which is analyzed using the external apparatus (paragraph [0067]).
In regard to claim 113, Escutia as modified discloses the invention of claim 88. Emery teaches that the detachable portion (FIG. 4, component 24) is removed and configured to be inserted into an external apparatus such as an electrochemical or photometric meter (paragraph [0045]).
In regard to claim 114, Escutia as modified discloses the invention of claim 100. Emery teaches that the detachable portion (FIG. 4, component 24) is removed and configured to be inserted into an external apparatus such as an electrochemical or photometric meter (paragraph [0045]).
Claim 91 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant) as applied to claim 88 above, and further in view of Kermani (US 20030106809 A1).
In regard to claim 91, Escutia as modified discloses the invention of claim 88, including detachable portion and an external apparatus that engages with the detachable portion such as an electrochemical or photometric meter to analyze the fluid sample collected on the analysis pad (paragraph [0067]). While Escutia discloses an external apparatus that comprises a sensor for determining an analyte, they do not specify that the external apparatus comprises one or more reagents able to interact with an analyte.
However, Kermani teaches a system and method for analyte detection that includes collecting a blood sample from a subject on an assay pad or test strip which is inserted into a test meter (paragraph [0050]) that detects a analyte concentration based on a redox reagent system wherein the reagent system includes a mediator component or reagent with chemical characteristics such that a potential difference occurs within the electrochemical cell upon the electrochemical reaction or interaction with a sample (paragraph [0050]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device disclosed by Escutia as modified, which includes inserting an assay pad into an external apparatus such as an electrochemical meter, with the teaching of Kermani that an electrochemical meter includes a reagent that interacts with a sample to generate an analyte concentration measurement (FIG. 2), because Escutia already discusses the use of an electrochemical meter such that modifying Escutia with the teachings of Kermani would be considered combining prior art elements according to known methods to yield the predictable results of measuring an analyte concentration from a sample on an assay pad or test strip.
Claim 94 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant) as applied to claim 88 above, and further in view of Montagu (US 20050178218 A1).
In regard to claim 94, Escutia as modified discloses the invention of claim 88. While Escutia discloses that the skin penetration member (FIG. 1, component 34) can take any suitable form (paragraph [0065]), they do not specify that the cutter comprises a blade.
However, Montagu teaches a blood sampling device where the skin penetration member is equipped with a sharp structure including a blade (paragraph [0050]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the skin penetration member disclosed by Escutia (FIG. 1, component 34) with the teaching by Montagu that the skin penetration member can comprise a blade because Escutia already discloses that the skin penetration member can take any suitable form. Modifying the skin penetration member disclosed by Escutia with the blade taught by Montagu would be considered simple substitution of one known element for another to obtain the predictable result of penetrating the skin.
Claims 95, 96, 98 and 105 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant) as applied to claim 88 and 100 above, and further in view of Lin (US 20020077584 A1).
In regard to claim 95, Escutia as modified discloses the invention of claim 88. While Escutia discloses an actuation element (FIG. 1, component 40) that can include any suitable structure including a reversibly deformable spring for driving a skin penetration member (FIG. 1, component 34) into the skin at a sampling site (paragraph [0068]), they do not specifically disclose that the first configuration of the reversibly deformable structure has a concave shape.
However, Lin teaches an actuation element (FIGs. 6 - 8, component 10) that features a dome shaped body formed of a deformable material that when pushed causes the skin penetrating members (FIGs. 7 & 8, component 4) to drive into the skin of a user and forms a partial vacuum that then pulls body fluid up into the sampling device (paragraph [0028]). FIG. 8 shows that the actuation element (component 10) has a first configuration with a concave shape.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the reversibly deformable actuation member disclosed by Escutia with the reversibly deformable actuation member taught by Lin because Escutia discloses that any suitable structure can be used as an actuation member (paragraph [0068]) and exchanging one actuation member for the other would be considered simple substitution of one known element for another to obtain the predictable result of driving a skin penetrating member into the skin of a user and collecting a body fluid.
In regard to claim 96, Escutia as modified discloses the invention of claim 88. While Escutia discloses an actuation element (FIG. 1, component 40) that can include any suitable structure including a reversibly deformable spring for driving a skin penetration member (FIG. 1, component 34) into the skin at a sampling site (paragraph [0068]), they do not specifically disclose that the first configuration of the reversibly deformable structure has a dome shape.
However, Lin teaches an actuation element (FIGs. 6 - 8, component 10) that features a dome shaped body formed of a deformable material that when pushed causes the skin penetrating members (FIGs. 7 & 8, component 4) to drive into the skin of a user and forms a partial vacuum that then pulls body fluid up into the sampling device (paragraph [0028]). FIG. 7 shows that the actuation element (component 10) has a first configuration with a dome shape.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the reversibly deformable actuation member disclosed by Escutia with the reversibly deformable actuation member taught by Lin because Escutia discloses that any suitable structure can be used as an actuation member (paragraph [0068]) and exchanging one actuation member for the other would be considered simple substitution of one known element for another to obtain the predictable result of driving a skin penetrating member into the skin of a user and collecting a body fluid.
In regard to claim 98, Escutia as modified discloses the invention as set forth for claim 97. While Escutia teaches that vacuum pressure can be applied to the sampling site before, during, and/or after lancing and that the vacuum pressure can be applied using several different techniques including a motor driven pump, individually packaged vacuum chambers, or a rigid syringe (paragraph [0055]) to form a seal between the surface of the device (FIG. 1, component 33) and the skin of the user at the sampling site (FIG. 1, components 12 & 14; paragraph [0064]), they do not specifically disclose that the vacuum source that is configured to manually create a vacuum upon actuation of the device.
However, Lin teaches a transdermal sampling device for collecting a body fluid that includes a mechanism for manually creating a vacuum during actuation of the device where a user pushes downward on a button or knob (FIG. 11 & 12, component 125) to cause a partial vacuum due to the downward movement of the piston (FIG. 11, component 131) and pierce the skin to extract a body fluid (paragraphs [0035] - [0036]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sampling device disclosed by Escutia with the teaching of Lin, that a vacuum can be manually applied upon actuation of a sampling device because Escutia already indicates that different mechanisms, including use of a rigid syringe, can be used to apply a vacuum upon actuation of a sampling device and modifying Escutia with the teachings of Lin would be considered simple substitution of one known element, in this case the vacuum applying mechanism, for another to obtain the predictable results of applying a vacuum to and collecting a bodily fluid from an area of skin.
In regard to claim 105, Escutia as modified discloses the invention as set forth for claim 100. While Escutia teaches that vacuum pressure can be applied to the sampling site before, during, and/or after lancing and that the vacuum pressure can be applied using several different techniques including a motor driven pump, individually packaged vacuum chambers, or a rigid syringe (paragraph [0055]) to form a seal between the surface of the device (FIG. 1, component 33) and the skin of the user at the sampling site (FIG. 1, components 12 & 14; paragraph [0064]), they do not specifically disclose that a vacuum source that is configured to manually create a vacuum upon actuation of the device.
However, Lin teaches a transdermal sampling device for collecting a body fluid that includes a mechanism for manually creating a vacuum during actuation of the device where a user pushes downward on a button or knob (FIG. 11 & 12, component 125) to cause a partial vacuum due to the downward movement of the piston (FIG. 11, component 131) and pierce the skin to extract a body fluid (paragraphs [0035] - [0036]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the sampling device disclosed by Escutia with the teaching of Lin, that a vacuum can be manually applied upon actuation of a sampling device because Escutia already indicates that different mechanisms, including use of a rigid syringe, can be used to apply a vacuum upon actuation of a sampling device and modifying Escutia with the teachings of Lin would be considered simple substitution of one known element, in this case the vacuum applying mechanism, for another to obtain the predictable results of applying a vacuum to and collecting a bodily fluid from an area of skin.
Claim 99 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant) as applied to claims 88 above, and further in view of Perez (US 20050004494 A1).
In regard to claim 99, Escutia as modified discloses the invention as set forth for claim 88. While Escutia discloses the use of a detachable portion that comprises an assay pad that includes a reagent that changes color upon reaction with a target analyte where the assay pad is removed from the device (FIG. 1, component 10) and inserted into a separate analyzer device, such as an electrochemical or photometric meter (paragraph [0067]), they do not specify that the detachable portion comprises paper.
However, Perez teaches a device for sampling body fluid that includes a removable test strip (FIG. 1, component 90) that is used to collect a body fluid and is then removed to determine information, such as an analyte level, using an optical sensor (paragraph [0081]). Perez further teaches that paper test strips are well known in the art (paragraph [0010]).
It would have been obvious to one of ordinary skill in the art to have modified the assay pad disclosed by Escutia with the teaching that a paper test strip can be used as a detachable portion for collecting and analyzing a body fluid because it would be considered simple substitution of one element, in this case the assay pad disclosed by Escutia, with for another, in this case the paper test strip taught by Perez, to obtain the predictable results of collecting a body fluid using a collecting device and analyzing the sample using an external device such as an optical measuring system.
Claim 109 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant) as applied to claim 106 above, and further in view of Dykes (US 20080025872 A1).
In regard to claim 109, Escutia as modified discloses the invention as set forth for claim 106. While Escutia discloses that blood samples are captured using the assay pad (FIG. 1, component 38) which is removed from the device and transferred to an external apparatus for analysis of the sample, Escutia does not disclose that the method comprises causing the blood to flow out of the detachable portion after engaging the detachable portion with the external apparatus.
However, Dykes teaches that blood can be collected in a detachable portion made up of a capillary tube structure with a bulb (FIG. 300) which can then be placed in an external holder (FIG. 10, component 310) of an external apparatus, in this case an analysis device (FIG. 10), where the bulb is depressed causing the blood stored in the capillary tube of the device (FIG. 10, component 300) to flow into a testing chamber (FIG. 10, component 325) and interact with the sensors of the external apparatus (FIG. 10, component 328; paragraph [0063]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the fluid collection mechanism and analysis method disclosed by Escutia with the teaching that blood can be collected using capillary tube structures and that blood can flow and be deposited in an external apparatus for analysis because it would be considered simple substitution of one known element, in this case the removable assay pad used to collect a blood sample and engage with an external apparatus to analyze the collected blood sample disclosed by Escutia, with another known element, in this case the capillary tube structure taught by Dykes that is used to collect a blood sample and then engages with an external apparatus to analyze the collected blood sample, to obtain the predictable results of collecting and analyzing a blood sample.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/11/2026, with respect to the 35 U.S.C. 112(b) rejections of claims 98, 103, 107, 108, and 109 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of claims 98, 103, 107, 108, and 109 have been withdrawn.
Applicant’s arguments, see Remarks, filed 05/11/2026, with respect to the 35 U.S.C. 112(d) rejections of claims 89 - 91 and 101 have been fully considered and are persuasive. The 35 U.S.C. 112(d) rejections of claims 89 - 91 and 101 have been withdrawn.
Applicant’s arguments, see Remarks, filed 05/11/2026, with respect to the 35 U.S.C. 102 rejections of claims 88 - 93, 97, 100 - 103, 106 - 108, and 110 and the 35 U.S.C. 103 of claims 91, 94, 95, 96, 98, 99, 105, and 109 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Escutia (US 20100010374 A1 - cited by applicant) in view of Emery (US 20100021947 A1 - cited by applicant) for independent claims 88, 100, and 106 that further apply to the dependent claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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