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 .
Response to Amendment
The amendment filed 09 February 2026 has been entered. Claim(s) 1-26 and 47-50 are pending in the application. Applicant’s amendments to the claims have overcome each and every objection to the claims previously set forth in the Office Action mailed 10 October 2025.
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 3 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.
The term “generally” in claim 3 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As a result, it is not clear what range of geometries may be encompassed by the .
The term “substantially” in claim 47 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what range of angles may be encompassed by the phrase "substantially perpendicular".
Claim 48 recites the limitation “the puncture element”. There is insufficient antecedent basis for this limitation of the claim.
The term “generally” in claim 49is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what range of geometries may be encompassed by the phrase "generally conical". Furthermore, it is not clear if the inclusion of “such that its diameter increases distally” is meant to delineate what is meant by “generally conical”, or if this limitation is meant to further limit the shape of the isolation chamber, separate from the requirement that the chamber be “generally conical”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-8, 10-18, 20, 24, 26, and 48-49 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jordan (US 20200163603 A1).
Regarding claim 1, Jordan discloses a handheld device for collecting a blood sample from a subject (100), the handheld device comprising:
an actuator assembly (Piercing activator and button 166, 167; paragraph 0162, 0220-0222);
a cartridge (110), the cartridge comprising a housing (Outer sidewall of base 110) having a distal body-contacting interface (Bottom face of the base 110, including the area around recess 136);
a body (152) housing the actuator assembly and having a proximal end (Proximal end of the housing 152 near window 153, Fig. 2B-3A) and a cavity (Cavity shown in Fig. 2C-3A, including space beneath the housing 152) configured to releasably receive the cartridge (110 ; paragraph 0160, 0169-- The housing can include a housing base 110 and a housing cover 152 operably coupled to each other… The housing base 110 and the housing cover 152 can each be separately provided, and coupled together to form the housing) to couple to the actuator assembly (Paragraph 0053, 0220-0222—the piercing elements can be actuated with a button…; paragraph 0169-- The housing cover can include a through-hole 153 through which the button 167 of the piercing activator 166 can be inserted), the cartridge being configured to capture the blood sample from the subject (Paragraph 0168-- The cartridge can be configured to support one or more matrices 186 on which the fluid sample (e.g., blood) is collected…);
a handle coupled to the proximal end of the body (Portion of the housing 152 including window 153 can be grabbed and handled and thus constitutes a handle, Fig. 2B-3A); and
a position detection system coupled to the body and having at least one sensor configured to determine a position of the cartridge relative to a target area of the subject when the cartridge is disposed within the cavity (Paragraph 0244--the device can be configured to automatically apply the vacuum upon sensing or detecting that the device has been placed on a surface (e.g., on a subject's skin), or that the recess of the device is properly placed over the surface…the piercing elements can be automatically activated to penetrate the surface (e.g., a subject's skin) upon sensing or detecting that the surface is drawn into the recess of the device, and/or that the surface is in proximity to the opening (e.g., 140) of the recess. The above sensing or detection (for the vacuum activation and/or piercing activation) can be enabled using any variety or number of sensors…),
wherein the body-contacting interface is a grooved channel configured to stabilize the target area during capture of the blood sample from the subject (Paragraph 0163-- The housing base can include a planar portion 132 to be placed on the subject's skin. The planar portion can surround the periphery of the recess. The planar portion of the housing base can have any shape. Optionally in any of the embodiments disclosed herein, the planar portion can include an annular ring-like shape… Optionally in any of the embodiments disclosed herein, a fillet 138 can be provided between the periphery of the recess and the planar portion of the housing base. The fillet can improve vacuum suction to the skin and reduce leaks).
Regarding claim 2, Jordan discloses the handheld device of claim 1. Jordan additionally discloses wherein the cartridge further comprises:
at least one blood storage container contained within the housing (Matrices 186);
a puncture assembly contained within the housing (Piercing module 154) and comprising a puncture element moveable relative to the housing (Piercing elements 158) and contained within the housing in an initial position and extending from the body-contacting interface in an extended position (Paragraph 0169, 0234-0235, 0276); and
a blood drawing assembly coupled configured to collect the blood sample from a puncture created in the target area by the puncture element in the extended position, wherein the blood drawing assembly delivers the blood sample to the at least one blood storage container (Port 144, channel 146 and port 148; Fig. 3A; paragraph 0247-- As shown in FIG. 3A, the channel 146 can extend towards the port 144 which is adjacent to the opening 140 of the recess 136. Blood can be drawn from the penetrated skin of the subject, and transported through the channels 146 and 185 into the cartridge with aid of vacuum, pressure differentials, and gravitational force).
Regarding claim 3, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the grooved channel Is generally V-shaped and opens outward toward the target area of the subject (Paragraph 0163-- The housing base can include a planar portion 132 to be placed on the subject's skin. The planar portion can surround the periphery of the recess. The planar portion of the housing base can have any shape. Optionally in any of the embodiments disclosed herein, the planar portion can include an annular ring-like shape…; Fig. 1B shows that the recess and surrounding groove 138 may be cup shaped, opening outward toward the target area of the subject where a cup is generally V-shaped).
Regarding claim 4, Jordan discloses the handheld device of claim 3. Jordan additionally discloses wherein the body-contacting interface comprises an opening that receives therethrough an isolation chamber coupled to the housing (recess 136 extends through the bottom face planar portion 132), the isolation chamber having a central opening (Opening 140) that receives therethrough the puncture element in the extended position (Paragraph 0163-0164--The one or more piercing elements can be configured to extend out of the opening to penetrate the subject's skin when (or after) the skin is drawn into the recess by vacuum pressure. The one or more piercing elements can be subsequently retracted back into the housing after penetrating the skin).
Regarding claim 5, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the blood drawing assembly is coupled to the puncture assembly (The assemblies are coupled via the base 110; Fig. 3A).
Regarding claim 7, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the puncture element has at least one through opening (Paragraph 0217).
Regarding claim 8, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the puncture element is a solid element (Paragraph 0217).
Regarding claim 10, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the isolation chamber is retractable such that it is retracted proximally towards the housing when the puncture element moves from the initial position to the extended position (Paragraph 0177-- The recess can be shaped like a cup and configured to provide a skin “cupping” effect with aid of vacuum pressure; paragraph 0184, 0186-- the recess can have a flexible surface (e.g. a flexible concave surface). For example, the bottom of the recess can include an elastic material such as an elastomer. The elastic material can be configured to conform to the skin when the skin is drawn into the recess).
Regarding claim 11, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein an outer surface of the housing of the cartridge has at least one longitudinal groove extending from a proximal end of the housing towards a distal end of the housing and configured to mate with a corresponding protrusion formed on an inner surface of the cavity (See Fig. 3A, a longitudinal groove of the housing is formed over chamber 126, a corresponding protrusion of the housing 152 mates with this groove).
Regarding claim 12, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein at least one blood storage container comprises first and second blood storage containers (See Fig. 29—first and second matrices 186 separated by spacer 127) disposed on opposite sides of the puncture assembly (See Figs. 3A and 3B—the first and second blood storage containers as shown in Fig. 29 would be disposed on opposite sides (e.g., on a side of the assembly nearest to the bottom of Fig. 3B and on an opposite side, nearer to the top as shown in Fig. 3B)).
Regarding claim 13, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the actuator assembly (Paragraph 0162-- In some cases, the vacuum activator is locked prior to use of the device, and the vacuum activator can be activated only after the piercing activator has been activated. The piercing activator (e.g., button 115) and vacuum activator (e.g., button 167) can be located on the same side or face of the housing) is configured to apply negative pressure to the target area while the blood drawing assembly draws the blood sample through the puncture in the target area (Paragraph 0162-0163-- A portion of a subject's skin can be drawn into the recess with aid of vacuum pressure, e.g., as described elsewhere herein).
Regarding claim 14, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the actuator assembly (Paragraph 0162-- In some cases, the vacuum activator is locked prior to use of the device, and the vacuum activator can be activated only after the piercing activator has been activated. The piercing activator (e.g., button 115) and vacuum activator (e.g., button 167) can be located on the same side or face of the housing) is configured to apply a vacuum pressure to the target area while the blood drawing assembly draws the blood sample through the puncture in the target area, and wherein the actuator assembly is configured to increase and decrease the vacuum pressure one or more times (Paragraph 0162-0163, 0179-0180, 0200-0215-- A portion of a subject's skin can be drawn into the recess with aid of vacuum pressure, e.g., as described elsewhere herein).
Regarding claim 15, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein at least one blood storage container comprises an access port for removing the blood sample from at least one blood storage container (Port 184).
Regarding claim 16, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the blood drawing assembly comprises at least one fluid conduit configured to deliver the blood sample acquired through the puncture to the at least one blood storage container (Port 144, channel 146 and port 148; Fig. 3A; paragraph 0257).
Regarding claim 17, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the actuator assembly is configured to be activated to cause the puncture element of the puncture assembly to puncture a skin surface of the subject at the target area and to cause a blood withdrawal assembly to collect the blood sample from the target area through a puncture in the target area into the cartridge (Paragraph 0162-- In some cases, the vacuum activator is locked prior to use of the device, and the vacuum activator can be activated only after the piercing activator has been activated; Paragraph 0163-0164--The one or more piercing elements can be configured to extend out of the opening to penetrate the subject's skin when (or after) the skin is drawn into the recess by vacuum pressure. The one or more piercing elements can be subsequently retracted back into the housing after penetrating the skin; paragraph 0247--Blood can be drawn from the penetrated skin of the subject, and transported through the channels 146 and 185 into the cartridge with aid of vacuum, pressure differentials, and gravitational force).
Regarding claim 18, Jordan discloses the handheld device of claim 2. Jordan additionally discloses wherein the body-contacting interface is formed of at least partially compressible material (Paragraph 0192-- An appropriate biocompatible adhesive material or gasket material can be placed on the planar portion on the housing base, to promote adhesion of the device onto the subject's skin for improved contact. Any suitable adhesive can be used. The adhesive can be a hydrogel, an acrylic, a polyurethane gel, a hydrocolloid, or a silicone gel).
Regarding claim 20, Jordan discloses the handheld device of claim 1. Jordan additionally discloses wherein the at least one sensor comprises first and second optical sensors positioned on a distal side of the body, proximate to opposite sides of the cavity (Paragraph 0244-- the device can be configured to automatically apply the vacuum upon sensing or detecting that the device has been placed on a surface (e.g., on a subject's skin), or that the recess of the device is properly placed over the surface… The above sensing or detection (for the vacuum activation and/or piercing activation) can be enabled using any variety or number of sensors… sensors that can be used with any of the embodiments herein include proximity sensors, tactile sensors, acoustic sensors, motion sensors, pressure sensors, interferometric sensors, inertial sensors, thermal sensors, image sensors, and the like).
Regarding claim 24, Jordan discloses the handheld device of claim 1. Jordan additionally discloses wherein the actuator assembly comprises an actuator disposed on the handle and configured to be activated by a pressure applied thereto (Button 167 disposed on the handle portion of housing 152; paragraph 0232).
Regarding claim 26, Jordan discloses the handheld device of claim 1. Jordan additionally discloses wherein a portion of the body proximate to the cavity has curved skin contacting edges (Curved edges of housing 152).
Regarding claim 48, Jordan discloses the handheld device of claim 24. Jordan additionally discloses wherein the direction that the actuator (Button 167 disposed on the handle portion of housing 152; paragraph 0232) is activated is in the same direction that the puncture element (Piercing elements 158) moves from the initial position to the extended position to create a puncture in the target area (Paragraph 0232, 0238-- the vacuum activator can be located on the housing such that the button 115 is configured to be pressed in a first direction when the device is mounted onto the subject's arm. The piercing activator can be located on the housing such that the button 167 is configured to be pressed in a second direction when the device is mounted onto the subject's arm. In some embodiments, the first direction and the second direction can be substantially the same. The first direction and the second direction can be substantially parallel to each other. In some embodiments, the first direction and the second direction can be substantially different, e.g. orthogonal or oblique to each other; Note: an embodiment where the first and second direction are orthogonal can thus include the claimed arrangement of the actuator being activated in the same direction that the puncture element moves).
Regarding claim 49, Jordan discloses the handheld device of claim 4. Jordan additionally discloses an isolation chamber is generally conical such that its diameter increases distally (recess 136 extends through the bottom face planar portion 132 and has a generally conical shape with a diameter which increases distally from the opening 140 toward the skin-contacting interface; paragraph 0163, 0177, 0188-- A size of the recess 136 can be substantially greater than a size of the opening 140…).
Claim(s) 1-3, 5-9, 11-18, 20, and 24-26 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Escutia (US 20070083131 A1).
Regarding claim 1, Escutia discloses a handheld device for collecting a blood sample from a subject (Device 100), the handheld device comprising:
an actuator assembly (paragraph 0060, 0066-- Each needle hub 124 is, in turn, attached to an actuation element 126. It should be understood that a number of different actuation elements may be utilized according to the principles of the present invention…);
a cartridge (131), the cartridge comprising a housing (See Fig. 8) having a distal body-contacting interface of the housing (Footprint 120);
a body housing the actuator assembly (Portion of device 100 including door 123) and having a proximal end (Proximal end nearest to display 127) and a cavity (Cavity enclosed by door 123) configured to releasably receive a cartridge (Cartridge 131) to couple to the actuator assembly (Paragraph 0058-0059-0060), the cartridge being configured to capture the blood sample from the subject (Paragraph 0060);
a handle coupled to the proximal end of the body (Portion of device 100 including buttons 129 and around display 127 can be grabbed and handled and thus constitutes a handle); and
a position detection system coupled to the body and having at least one sensor configured to determine a position of the cartridge relative to a target area of the subject when the cartridge is disposed within the cavity (Paragraph 0050, 0056, 0066-- the device verifies that it is properly positioned on the skin of the user and ready to begin the sampling and analysis procedure. Suitable sensors to accomplish this include optical, capacitive or pressure sensors…),
wherein the body-contacting interface includes a grooved channel configured to stabilize the target area during capture of the blood sample from the subject (See Figs. 3-4; paragraph 0058-0059-- The integrated meter 100 may further comprise a footprint 120 of the type previously described…; paragraph 0046-- The footprint 20 has a central opening and may optionally have an annular in shape. However, the footprint is not limited to this shape or configuration. Numerous shapes or configurations may satisfy the function of providing a footprint around the site from which body fluid is to be expressed).
Regarding claim 2, Escutia discloses the handheld device of claim 1. Escutia additionally discloses the cartridge further comprising:
at least one blood storage container contained within the housing (Needle hubs 124 including reagent pads 129, Paragraph 0060);
a puncture assembly (Plurality of skin penetrating members 122 positioned about the cartridge 131) contained within the housing and comprising a puncture element (Skin penetration members 122; paragraph 0058) moveable relative to the housing and contained within the housing in an initial position and extending from the body-contacting interface in an extended position (See Figs. 3-4; paragraph 0058-0059-- The integrated meter 100 may further comprise a footprint 120 of the type previously described… upon sampling a skin-piercing element 22 is driven through an opening in the housing in registry with the footprint 120 and pierces the skin of the user); and
a blood drawing assembly coupled configured to collect the blood sample from a puncture created in the target area by the puncture element in the extended position, wherein the blood drawing assembly delivers the blood sample to the at least one blood storage container (Paragraph 0056, 0060-- The reagent pad 129 is in fluid communication with the inner lumen of the skin piercing element 122).
Regarding claim 3, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the grooved channel Is generally V-shaped and opens outward toward the target area of the subject (See Figs. 3-4 and 6-7, wherein Figs. 6-7 demonstrate a generally v-shaped channel which opens outward toward the target area; paragraph 0058-0059-- The integrated meter 100 may further comprise a footprint 120 of the type previously described…; paragraph 0041, 0046-- The footprint 20 has a central opening and may optionally have an annular in shape. However, the footprint is not limited to this shape or configuration. Numerous shapes or configurations may satisfy the function of providing a footprint around the site from which body fluid is to be expressed).
Regarding claim 5, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the blood drawing assembly is coupled to the puncture assembly (Paragraph 0060-- The reagent pad 129 is in fluid communication with the inner lumen of the skin piercing element 122).
Regarding claim 6, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the puncture element has a lumen extending therethrough and configured to deliver blood from the puncture to the at least one blood storage container (Paragraph 0052, 0056, 0060-- The reagent pad 129 is in fluid communication with the inner lumen of the skin piercing element 122).
Regarding claim 7, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the puncture element has at least one through opening (Paragraph 0052, 0056, 0060-- The reagent pad 129 is in fluid communication with the inner lumen of the skin piercing element 122).
Regarding claim 8, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the puncture element is a solid element (Paragraph 0047, 0056, 0060-- The skin penetration member can take any suitable form, such as a solid lancet or hollow needle (e.g., a microneedle)).
Regarding claim 9, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the puncture element has or is associated with a sensor configured to detect when the puncture element encounters liquid (Paragraph 0056, 0060-0061-- Upon exposure to the body fluid, a target analyte contained therein causes a chemical reaction producing a color change in the assay pad. This color change can in turn be detected by a suitable detection element. One such detection element utilizes colorimetric optical analysis of the assay pad. More specifically, an array of such detection elements can be provided along a longitudinal length of the assay pad… According to one embodiment, the reagent pad 129, upon reaction with the target analyte, produces a spot which is optically detected by the optical assembly 135… The optical detector element 142 generally comprises one or more detector elements).
Regarding claim 11, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein an outer surface of the housing of the cartridge has at least one longitudinal groove extending from a proximal end of the housing towards a distal end of the housing and configured to mate with a corresponding protrusion formed on an inner surface of the cavity (Cartridge 131 is placed about Hub 133, Fig. 7; paragraph 0059).
Regarding claim 12, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein at least one blood storage container comprises first and second blood storage containers disposed on opposite sides of the puncture assembly (Pads 129 are positioned interior of the piercing elements 122 about a circular structure (see Fig. 8) such that some of these pads are disposed on opposite sides of the puncture assembly).
Regarding claim 13, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the actuator assembly is configured to apply negative pressure to the target area while the blood drawing assembly draws the blood sample through the puncture in the target area (Paragraph 0062-- The integrated meter 100 may also include a catalyst device 114 comprising a pressure pump 151 which, according to certain embodiments, comprises a pump capable of producing at least a negative or vacuum pressure at the surface of the skin located over the footprint 120).
Regarding claim 14, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the actuator assembly is configured to apply a vacuum pressure to the target area while the blood drawing assembly draws the blood sample through the puncture in the target area, and wherein the actuator assembly is configured to increase and decrease the vacuum pressure one or more times (Paragraph 0062-- The integrated meter 100 may also include a catalyst device 114 comprising a pressure pump 151 which, according to certain embodiments, comprises a pump capable of producing at least a negative or vacuum pressure at the surface of the skin located over the footprint 120).
Regarding claim 15, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein at least one blood storage container comprises an access port for removing the blood sample from at least one blood storage container (Paragraph 0051).
Regarding claim 16, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the blood drawing assembly comprises at least one fluid conduit configured to deliver the blood sample acquired through the puncture to the at least one blood storage container (Paragraph 0052, 0056, 0060-- The reagent pad 129 is in fluid communication with the inner lumen of the skin piercing element 122).
Regarding claim 17, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the actuator assembly is configured to be activated to cause the puncture element of the puncture assembly to puncture a skin surface of the subject at the target area and to cause a blood withdrawal assembly to collect the blood sample from the target area through a puncture in the target area into the cartridge (Paragraph 0049, 0056-- When the user is ready to produce a sample of body fluid, the button B is pressed; paragraph 0058-- The integrated meter 100 may further include one or more buttons 129 which can be pressed by the user to engage various functions and interfaces of the integrated meter 100; paragraph 0060, 0066-- Each needle hub 124 is, in turn, attached to an actuation element 126. It should be understood that a number of different actuation elements may be utilized according to the principles of the present invention… Upon activation, the torsional spring drives the needle hub 124 and the attached skin penetration member 122 into the skin of the user disposed on the footprint 120… The skin penetration member comes to rest in or directly on the wound opening created at the sampling site where it obstructs the wound opening and is in the desired position for collecting a sample of body fluid expressed from the wound… A sample of body fluid is in fluid communication with a device or mechanism which creates a detectable signal upon reaction within analyte present in the sample body fluid. For example, one such suitable mechanism is an absorbent pad containing a chemical reagent which, upon reaction with the analyte produces a reaction spot which can be optically detected).
Regarding claim 18, Escutia discloses the handheld device of claim 2. Escutia additionally discloses wherein the body-contacting interface is formed of at least partially compressible material (See Figs. 3-4; paragraph 0058-0059-- The integrated meter 100 may further comprise a footprint 120 of the type previously described…; paragraph 0046-- According to certain embodiments, the footprint 20 is constructed from a material which facilitates the formation of a seal between the digit D and the footprint 20. For example, suitable materials for this purpose include a relatively soft elastomeric material, such as a silicone rubber.).
Regarding claim 20, Escutia discloses the handheld device of claim 1. Escutia additionally discloses wherein the at least one sensor comprises first and second optical sensors positioned on a distal side of the body, proximate to opposite sides of the cavity (Fig. 4 demonstrates positioning of sensors 27 relative to the footprint 20; paragraph 0050-- The arrangement 10 can be provided with one or more sensors 27 that detect and verify that the footprint is properly located and ready for the sampling procedure to begin; paragraph 0058-- The integrated meter 100 may further comprise a footprint 120 of the type previously described; Positioning of footprint 120 in Fig. 6-7).
Regarding claim 24, Escutia discloses the handheld device of claim 1. Escutia additionally discloses wherein the actuator assembly comprises an actuator disposed on the handle and configured to be activated by a pressure applied thereto (Paragraph 0049, 0056-- When the user is ready to produce a sample of body fluid, the button B is pressed; paragraph 0058-- The integrated meter 100 may further include one or more buttons 129 which can be pressed by the user to engage various functions and interfaces of the integrated meter 100).
Regarding claim 25, Escutia discloses the handheld device of claim 1. Escutia additionally discloses wherein the position detection system is activated automatically when the handheld device detects that the cartridge is received in the cavity and coupled to the actuator assembly (Paragraph 0049-0050-- the mode of operation can be fully automatic).
Regarding claim 26, Escutia discloses the handheld device of claim 1. Escutia additionally discloses wherein a portion of the body proximate to the cavity has curved skin contacting edges (See Fig. 6-7—portion of the body adjacent to the footprint 20 is curved where it contacts the skin).
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.
Claim(s) 19, 21-22, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Terashima (US 20140364767 A1).
Regarding claim 19, Jordan discloses the handheld device of claim 2. Jordan additionally discloses that a depth of a puncture created by a puncture element in the extended position may be varied (Paragraph 0221-0224-- The deployment spring can be configured to cause the one or more piercing elements to penetrate the skin to depths ranging from about 0.5 mm to about 3 mm).
However, Jordan fails to explicitly disclose a depth control actuator coupled to the body and configured to be actuated to control a depth of the puncture to be created by the puncture element in the extended position.
Terashima, in the same field of endeavor of a handheld device for collecting a liquid sample (Abstract), discloses a depth control actuator coupled to the body and configured to be actuated to control a depth of the puncture to be created by the puncture element in the extended position (Puncturing depth adjusting part 58; paragraph 0145, 0148).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device to include the depth control actuator of Terashima in order to predictably improve the comfort and usability of the device by allowing for the depth of puncture to be adjusted according to the needs of the user, as a user with thicker skin may require a deeper puncture while a user with thinner skin may experience more pain with too deep of a puncture.
Regarding claim 21, the combination of Jordan and Terashima discloses the handheld device of claim 19. Jordan additionally discloses where the position detection system comprises a graphical user interface configured to present a graphical indication of the position of the cartridge relative to the target area (Paragraph 0269-0270-- one or more graphical user interfaces (GUIs) can be provided on the device… The GUIs can allow a user to visually monitor the progress of the sample collection).
Regarding claim 22, the combination of Jordan and Terashima discloses the handheld device of claim 21. Jordan additionally discloses wherein the graphical user interface is disposed on a proximal side of the body (Paragraph 0270-- GUI; paragraph 0232-- The vacuum activator can include a first input interface, and the piercing activator can include a second input interface. The first and second input interfaces can be located on different parts of the housing. Examples of suitable input interfaces can include buttons, knobs, finger triggers, dials, touchscreens, keyboards, mice, or joysticks).
Regarding claim 50, Jordan discloses a handheld device for collecting a blood sample from a subject (100), the handheld device comprising:
an actuator assembly (Piercing activator and button 166, 167; paragraph 0162, 0220-0222);
a cartridge (110), the cartridge comprising a housing (Outer sidewall of base 110) having a distal body-contacting interface (Bottom face of the base 110, including the area around recess 136) and an opening that receives therethrough an isolation chamber coupled to the housing (recess 136 extends through the bottom face planar portion 132), the isolation chamber being generally conical such that its diameter increases distally (recess 136 extends through the bottom face planar portion 132 and has a generally conical shape with a diameter which increases distally from the opening 140 toward the skin-contacting interface; paragraph 0163, 0177, 0188-- A size of the recess 136 can be substantially greater than a size of the opening 140…) and having a central opening (Opening 140) that receives therethrough a puncture element (Paragraph 0163-0164--The one or more piercing elements can be configured to extend out of the opening to penetrate the subject's skin when (or after) the skin is drawn into the recess by vacuum pressure. The one or more piercing elements can be subsequently retracted back into the housing after penetrating the skin);
a body (152) housing the actuator assembly and having a proximal end (Proximal end of the housing 152 near window 153, Fig. 2B-3A) and a cavity (Cavity shown in Fig. 2C-3A, including space beneath the housing 152) configured to releasably receive the cartridge (110 ; paragraph 0160, 0169-- The housing can include a housing base 110 and a housing cover 152 operably coupled to each other… The housing base 110 and the housing cover 152 can each be separately provided, and coupled together to form the housing) to couple to the actuator assembly (Paragraph 0053, 0220-0222—the piercing elements can be actuated with a button…; paragraph 0169-- The housing cover can include a through-hole 153 through which the button 167 of the piercing activator 166 can be inserted), the cartridge being configured to capture the blood sample from the subject (Paragraph 0168-- The cartridge can be configured to support one or more matrices 186 on which the fluid sample (e.g., blood) is collected…);
a handle coupled to the proximal end of the body (Portion of the housing 152 including window 153 can be grabbed and handled and thus constitutes a handle, Fig. 2B-3A); and
a position detection system coupled to the body and having at least one sensor configured to determine a position of the cartridge relative to a target area of the subject when the cartridge is disposed within the cavity (Paragraph 0244--the device can be configured to automatically apply the vacuum upon sensing or detecting that the device has been placed on a surface (e.g., on a subject's skin), or that the recess of the device is properly placed over the surface…the piercing elements can be automatically activated to penetrate the surface (e.g., a subject's skin) upon sensing or detecting that the surface is drawn into the recess of the device, and/or that the surface is in proximity to the opening (e.g., 140) of the recess. The above sensing or detection (for the vacuum activation and/or piercing activation) can be enabled using any variety or number of sensors…),
wherein the body-contacting interface is a V-shaped grooved channel configured to stabilize the target area during capture of the blood sample from the subject (Paragraph 0163-- The housing base can include a planar portion 132 to be placed on the subject's skin. The planar portion can surround the periphery of the recess. The planar portion of the housing base can have any shape. Optionally in any of the embodiments disclosed herein, the planar portion can include an annular ring-like shape… Optionally in any of the embodiments disclosed herein, a fillet 138 can be provided between the periphery of the recess and the planar portion of the housing base. The fillet can improve vacuum suction to the skin and reduce leaks; Fig. 1B shows that the recess and surrounding groove 138 may be cup shaped, opening outward toward the target area of the subject where a cup is generally V-shaped),
wherein the actuator assembly (Paragraph 0162-- In some cases, the vacuum activator is locked prior to use of the device, and the vacuum activator can be activated only after the piercing activator has been activated. The piercing activator (e.g., button 115) and vacuum activator (e.g., button 167) can be located on the same side or face of the housing) is configured to apply negative pressure to the target area while the blood drawing assembly draws the blood sample through the puncture in the target area (Paragraph 0162-0163-- A portion of a subject's skin can be drawn into the recess with aid of vacuum pressure, e.g., as described elsewhere herein), the puncture having the isolation chamber disposed thereon such that, as the blood sample is captured from the subject, the skin at the target area is drawn into the isolation chamber in a dome-like shape with the puncture at the apex (Paragraph 0162-0163).
However, Jordan fails to explicitly disclose a depth control actuator coupled to the body and configured to be actuated to control a depth of the puncture to be created by the puncture element.
Terashima, in the same field of endeavor of a handheld device for collecting a liquid sample (Abstract), discloses a depth control actuator coupled to the body and configured to be actuated to control a depth of the puncture to be created by the puncture element in the extended position (Puncturing depth adjusting part 58; paragraph 0145, 0148).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device to include the depth control actuator of Terashima in order to predictably improve the comfort and usability of the device by allowing for the depth of puncture to be adjusted according to the needs of the user, as a user with thicker skin may require a deeper puncture while a user with thinner skin may experience more pain with too deep of a puncture.
Claim(s) 19 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Escutia in view of Terashima (US 20140364767 A1).
Regarding claim 19, Escutia discloses the handheld device of claim 2. Escutia additionally discloses that it is known in the art to control a depth of a puncture created by a puncture element in the extended position (Paragraph 0008).
However, Escutia fails to explicitly disclose a depth control actuator coupled to the body and configured to be actuated to control a depth of the puncture to be created by the puncture element in the extended position.
Terashima, in the same field of endeavor of a handheld device for collecting a liquid sample (Abstract), discloses a depth control actuator coupled to the body and configured to be actuated to control a depth of the puncture to be created by the puncture element in the extended position (Puncturing depth adjusting part 58; paragraph 0145, 0148).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device to include the depth control actuator of Terashima in order to predictably improve the comfort and usability of the device by allowing for the depth of puncture to be adjusted according to the needs of the user, as a user with thicker skin may require a deeper puncture while a user with thinner skin may experience more pain with too deep of a puncture.
Regarding claim 21, the combination of Escutia and Terashima discloses the handheld device of claim 19. Escutia additionally discloses where the position detection system comprises a graphical user interface configured to present a graphical indication of the position of the cartridge relative to the target area (Display 127; paragraph 0056, 0066).
Regarding claim 22, the combination of Escutia and Terashima discloses the handheld device of claim 21. Escutia additionally discloses wherein the graphical user interface is disposed on a proximal side of the body (Display 127).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Arnold (US 20220409826 A1).
Regarding claim 23, Jordan discloses the handheld device of claim 20. Jordan additionally discloses the device presenting a visual indicator for correct positioning (Paragraph 0241, 0244-- the vacuum activator can be configured to generate one or more visual, audio, tactile, and/or message signals to indicate the status of the vacuum to a user… the device can be configured to automatically apply the vacuum upon sensing or detecting that the device has been placed on a surface (e.g., on a subject's skin), or that the recess of the device is properly placed over the surface). However, Jordan fails to explicitly disclose wherein the target area comprises a vein, and the graphical user interface displays an indictor indicating a position of the cartridge relative to the vein.
Arnold, in the same field of endeavor of a device including sensors to position a piercing element for collecting a blood sample(Abstract; paragraph 0054, 0137), discloses a device including optical sensors (Paragraph 0083) wherein the target area comprises a vein, and the graphical user interface displays an indictor indicating a position of the cartridge relative to the vein (Paragraph 0084-- In numerous embodiments, processes can use filters and image processing techniques to, e.g., identify a vein by determining a different colored vein-like portion of the image, and identify the edges of those veins. Processes in accordance with certain embodiments of the invention can determine a distance and direction the needle must move in order for the needle to be approximately centered within a detected vein, and can move the needle laterally until the needle is in the correct location. This process may be performed iteratively until the system verifies the needle is in the correct location. If no vein is detected, processes in accordance with certain embodiments of the invention can provide a notification (e.g., a sound, light, visual display, etc.) to indicate no vein had been detected, and that the cuff may need to be repositioned).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system, which already includes optical sensors to enable proper positioning of the device, to specifically include a target area of a vein and displaying related information as disclosed by Arnold in order to predictably improve the ease of use of the device by allowing a user to see not just that the cartridge is properly placed but also, if the cartridge is not properly placed, to easily understand what adjustments must be made to the placement.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Escutia in view of Arnold (US 20220409826 A1).
Regarding claim 23, Escutia discloses the handheld device of claim 20. Escutia additionally discloses a display (127). However, Escutia fails to explicitly disclose wherein the target area comprises a vein, and the graphical user interface displays an indictor indicating a position of the cartridge relative to the vein.
Arnold, in the same field of endeavor of a device including sensors to position a piercing element for collecting a blood sample(Abstract; paragraph 0054, 0137), discloses a device including optical sensors (Paragraph 0083) wherein the target area comprises a vein, and the graphical user interface displays an indictor indicating a position of the cartridge relative to the vein (Paragraph 0084-- In numerous embodiments, processes can use filters and image processing techniques to, e.g., identify a vein by determining a different colored vein-like portion of the image, and identify the edges of those veins. Processes in accordance with certain embodiments of the invention can determine a distance and direction the needle must move in order for the needle to be approximately centered within a detected vein, and can move the needle laterally until the needle is in the correct location. This process may be performed iteratively until the system verifies the needle is in the correct location. If no vein is detected, processes in accordance with certain embodiments of the invention can provide a notification (e.g., a sound, light, visual display, etc.) to indicate no vein had been detected, and that the cuff may need to be repositioned).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system, which already includes optical sensors to enable proper positioning of the device, to specifically include a target area of a vein and displaying related information as disclosed by Arnold in order to predictably improve the ease of use of the device by allowing a user to see not just that the cartridge is properly placed but also, if the cartridge is not properly placed, to easily understand what adjustments must be made to the placement.
Response to Arguments
Applicant's arguments filed 09 February 2026 have been fully considered but they are not persuasive.
While applicant argues that Jordan does not teach or suggest a V-shaped grooved channel, the citations of Jordan have been updated above to demonstrate the related teachings. Specifically, the planar portion of Jordan including the fillet may be seen to sufficiently disclose a V-shaped grooved channel.
Similarly, while applicant argues that Escutia fails to teach or suggest the same limitation, the figures of Escutia demonstrate a generally V-shaped grooved channel.
Conclusion
No prior art rejection has been applied to new claim 47. The most pertinent prior art of the record, Jordan, generally teaches some indicia may be provided that can be indicative of function of the device which relates to the sensors (Paragraph 0241--the vacuum activator can be configured to generate one or more visual, audio, tactile, and/or message signals to indicate the status of the vacuum to a user. The signals can indicate to the user, for example that (1) the vacuum has been activated, (2) the pressure(s) within the different chamber(s), (3) the vacuum post internal pressure equalization, (4) that the piercing activator is next ready for activation, and the like. The visual signals can be generated using visible markers that are viewable to the naked eye. A visible marker can include an image, shape, symbol, letter, number, bar code (e.g., 1D, 2D, or 3D barcode), quick response (QR) code, or any other type of visually distinguishable feature…visible markers can be substantially flat, raised, indented, or have any texture…). However Jordan does not explicitly disclose wherein the body includes one or more indicia extending substantially perpendicular to a longitudinal axis of the body that denote the location of the first and second optical sensors. Similarly, while other prior art discloses indicia relating to sensors of a handheld device, the prior art generally fails to disclose indicia which indicate the location of the sensors, rather than which indicate some parameter being sensed by the sensors.
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 ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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