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 02 September has been entered. Claim(s) 1-26 and 47-5 pending in the application. Applicant’s amendments to the claims have overcome each and every rejection of the claims under 35 U.S.C. 112(b) and the rejection of claim 1 and its dependents in view of Jordan as previously set forth in the Office Action mailed 03 June 2026.
Claim Objections
Claim 52 is objected to because of the following informalities: "being coplanar" should be "are coplanar" in line 2 of the claim. Appropriate correction is required.
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) 1-3, 5-9, 11-18, 20, and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Escutia (US 20070083131 A1) in view of Freeman (US 20120283539 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 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).
However, Escutia does not explicitly disclose the grooved channel having two opposing open sides such that the target area passes through the grooved channel.
Freeman, in the same field of endeavor of a handheld body fluid testing device, teaches a device including a grooved channel having two opposing open sides such that the target area passes through the grooved channel (Fig. 51 and 53-56, Ergonomic contour 426 or alternatively Fig. 63 and 65, concave depression 598 which includes cradle 602 which serve the same function and wherein Figs. 53, 56, and 63 specifically demonstrate the grooved channel has two opposing open sides through which the target area passes; Paragraph 0234-0239-- The sample reservoir 422 has a narrow input port 424 on the ergonomically contoured surface 426, which is adjacent to the distal end 414 of the lancet 412. The term ergonomically contoured, as used herein, generally means shaped to snugly fit a finger or other body portion to be lanced or otherwise tested placed on the surface; paragraph 0278, 0280-- a cradle 602 for positioning the user's finger or other body part, a sampling port 603 within the cradle 602).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the grooved channel of Escutia to have the shape described by Freeman in order to predictably improve the ease of use of the device by reducing the likelihood of a user’s finger slipping off of the body-contacting interface by providing a shape which would snugly accommodate a target site therethrough, and wherein Escutia describes that the interface (the footprint 120) may have alternative shapes or configurations.
Regarding claim 2, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman discloses the handheld device of claim 2. Escutia additionally discloses wherein the grooved channel Is 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 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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, the combination of Escutia and Freeman 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(s) 19 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Escutia in view of Freeman, further in view of Terashima (US 20140364767 A1).
Regarding claim 19, the combination of Escutia and Freeman 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, Freeman, 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 Escutia in view of Freeman, further in view of Arnold (US 20220409826 A1).
Regarding claim 23, the combination of Escutia and Freeman 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.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US 20200163603 A1) in view of Terashima (US 20140364767 A1).
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 slidably coupled to the housing (recess 136 extends through the bottom face planar portion 132; paragraph 0248), the isolation chamber being conical such that its diameter increases distally (recess 136 extends through the bottom face planar portion 132 and has a 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.
Allowable Subject Matter
Claim 51 is allowable.
Claims 4, 10, 4 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4, 10, and 49, the prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “wherein the body-contacting interface comprises an opening that receives therethrough an isolation chamber coupled to the housing, the isolation chamber having a central opening that receives therethrough he puncture element in the extended position”. While the most pertinent prior art of the record, Jordan, discloses this element alone, Jordan teaches away from the newly amended limitation of independent claim 1 of “the grooved channel having two opposing open sides such that the target area passes through the grooved channel”. The next most pertinent prior art of the record, Escutia, fails to describe an isolation chamber received through the body-contacting surface and provides no suggestion for such a modification. An attempt to modify Escutia would require extensive changes to the structure of the device to maintain the desired functioning which would not have been obvious to one having ordinary skill in the art.
Regarding claim 48, the prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “wherein the direction that the actuator is activated is in the same direction that the puncture element moves from the initial position to the extended position to create a puncture in the target area”. While the most pertinent prior art of the record, Jordan discloses this element alone, Jordan teaches away from the newly amended limitation of independent claim 1 of “the grooved channel having two opposing open sides such that the target area passes through the grooved channel”. The next most pertinent prior art of the record, Escutia, fails to describe such an arrangement and instead teaches only arrangements wherein the direction that the actuator is activated is orthogonal to the direction that the puncture element moves (See Fig. 1 and 6). Furthermore, a modification to move the actuator of Escutia to the bottom of the device such that the direction of the actuator activation would be the same as the direction of the puncture element movement would require extensive changes to the structure of the device to maintain the desired functioning which would not have been obvious to one having ordinary skill in the art (see internal structure of the device in Fig. 10, where movement of the actuator would displace the battery and require modification of the circuit board arrangement, as well as Fig. 6 which demonstrates a position of a display screen which is operated by some of the buttons).
Regarding claims 47 and 51, the prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “wherein the body includes one or more indicia extending perpendicular to a longitudinal axis of the body that denote the location of the first and second optical sensors”.
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 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 including Escutia fails to disclose indicia which indicate the location of the sensors, rather than which indicate some parameter being sensed by the sensors.
Regarding claim 52, the prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations “wherein a distal side of the body and a distal end of the cartridge being coplanar when the cartridge is disposed within the cavity”.
The most pertinent prior art of the record, Escutia, demonstrates a distal side of the body being coplanar with a face of the cartridge when the cartridge is disposed within the cavity, while the distal end of the cartridge is not coplanar but orthogonal to the plane of the distal side of the body (See Figs. 6-8, where a distal end of the cartridge is positioned approximately at the footprint 120 and thus orthogonal to the plane of the distal side of the body indicated by element 123; paragraph 0059 explains that the cartridge need not be circular, such that the distal “end” would thus be positioned at the footprint 120 when the cartridge has a polygonal or otherwise elongated shape). An attempt to modify Escutia would require extensive changes to the structure of the device to maintain the desired functioning which would not have been obvious to one having ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 02 September 2026 with regard to Escutia have been fully considered but they are not fully persuasive.
Newly cited reference Freeman has been provided to disclose the newly amended limitation of claim 1. Regarding applicant’s argument that footprint 20/120 is “required to form a seal between the site and the device” such that the footprint could not include two opposing sides, the cited paragraph 0046 of Escutia describes this as a requirement of particular embodiments such that other embodiments exist in which a seal is not formed. Such possibilities are further discussed in paragraphs 0039-0045, which describe the desired function is to “cause the area of the skin from which the sample of body fluid is to be expressed to become perfused with blood and/or body fluid” and where paragraph 0041 describes a pressure catalyst as circumferentially surrounding and squeezing a digit or body part, each of which may be accomplished with the grooved channel as described by the combination of Escutia and Freeman.
The claims remain rejected in view of Escutia.
Applicant’s arguments, see page , filed 02 September 2026, with respect to the rejection of the claims under 35 U.S.C. 102 in view of Jordan have been fully considered and are persuasive. The rejection of claims has been withdrawn.
In particular, the examiner agrees that the disclosure of Jordan teaches away from the newly amended limitation of “the grooved channel having two opposing open sides such that the target area passes through the grooved channel”.
Applicant’s arguments, see page 11 of applicant's response, filed 02 September 2026, with respect to the rejection of the claims under 35 U.S.C. 103 in view of Jordan have been fully considered and are partially persuasive.
The rejection of claims 19 and 21-22 over Jordan in view of Terashima and the rejection of claim 23 over Jordan in view of Arnold are additionally withdrawn in light of the amendments to independent claim 1.
However, the rejection of claim 50 over Jordan in view of Terashima is maintained as claim 50 does not appear to include similar limitations to claim 1 which were successfully argued by the applicant. Specifically, claim 50 lacks any limitation relating to “the grooved channel having two opposing open sides such that the target area passes through the grooved channel”. As a result, it appears that the combination of Jordan and Terashima continues to disclose all limitations of claim 50 and the rejection is maintained.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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