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 .
Notice of Amendment
In response to the amendment filed on 4/1/2026, amended claims 1, 3, 5, 9, 11, and 17 and cancelled claims 2, 10, and 13 are acknowledged. Claims 1, 3-9, 11-12, and 14-20 are currently pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 5, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keren (US Patent No. 7,591,791 B2) (cited by Applicant).
Regarding claim 1, Keren discloses a finger cuff device for use in capillary blood sample collection comprising:
a finger cuff comprising:
an open end (14) portion sized to accommodate a user's finger (see Figures 1-3 and col. 4, lines 9-11 – “Thimble body 12 is open at one end 14 for receiving a finger 5 and is preferably closed at the opposite end 16”),
a finger stop end portion (20) opposite the open end portion (see Figures 3-4 and col. 4, lines 28-31 – “A stopper wall 20 located at a predetermined distance from opening 14 adjusts the position of finger 5 in relation to puncturing unit 30 by preventing the finger from penetrating further into the body cavity”),
an outer sidewall (see Figures 1-4),
an inner sidewall (see Figures 3-4), and
at least one lancet guide opening (25) formed through the outer sidewall and inner sidewall (see Figures 3-4 and col. 4, lines 40-41 – “A small opening 25 in wall 12 allows lancet 35 when fired to penetrate through wall 12 into finger tip 4”); and
at least one integrated absorbent pad (17, 19, 50) positioned on the inner sidewall of the finger cuff (see Figures 3-4 and col. 4, line 60-col. 5, line 2 – “A wick member 19, having one end in contact with the inner surface of membrane 17 and a second end in contact with the sample receiving zone of strip 50 may optionally be added to serve as a bridging element between the two. Wick member 19 may be made of glass fiber, polyester or other filter material known in the art. Alternatively, sample receiving end 52 may be in direct contact with membrane 17 or may be positioned on top of membrane 17 directly below lancet 35 such that blood is directly applied on the sample receiving zone”),
wherein the at least one lancet guide opening is positioned off-center from a centerline of the finger cuff (see Figure 3 and annotated version below) and the at least one integrated absorbent pad is aligned in-line with the at least one lancet guide opening relative to the centerline (see Figure 4; element 17 aligned with opening 25).
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Regarding claim 3, Keren discloses alignment of the at least one lancet guide opening allows for absorption of a first drop of blood when removing the finger cuff device from the user’s finger after lancing of the finger (see Figures 3-4).
Regarding claim 5, Keren discloses the at least one integrated absorbent pad is positioned on the inner sidewall in line with the at least one lancet guide (see Figures 3-4 and col. 4, line 60-col. 5, line 2 – “A wick member 19, having one end in contact with the inner surface of membrane 17 and a second end in contact with the sample receiving zone of strip 50 may optionally be added to serve as a bridging element between the two. Wick member 19 may be made of glass fiber, polyester or other filter material known in the art. Alternatively, sample receiving end 52 may be in direct contact with membrane 17 or may be positioned on top of membrane 17 directly below lancet 35 such that blood is directly applied on the sample receiving zone”).
Regarding claim 8, Keren discloses the finger cuff is formed of an elastic material (see col. 4, lines 12-15 – “Preferably body 12 is fabricated from low-cost sterilizable plastic material such as PET (polyethylene), polystyrene and the like by a mold injection process”).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren, further in view of Yeoh et al. (US Publication No. 2005/0216046 A1) (previously cited).
Regarding claim 4, it is noted Keren does not specifically teach the at least one lancet guide opening is elongated relative to a longitudinal axis of the finger cuff. However, Yeoh et al. teaches the at least one lancet guide opening (9) is elongated relative to a longitudinal axis of the finger cuff (3) (see Figure 1B and [0017] – “The lancet insertion aperture (9) is longer than the lancet disposition aperture (8)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Keren to include the at least one lancet guide opening is elongated relative to a longitudinal axis of the finger cuff, as disclosed in Yeoh et al., so as to guide the lancet into the device.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren, further in view of Haines et al. (US Publication No. 2023/0309871 A1) (cited by Applicant).
Regarding claim 6, it is noted Keren does not specifically teach a pair of open portions formed on respective sides of the finger cuff. However, Haines et al. teaches a pair of open portions (12) formed on respective sides of the finger cuff (see Figure 1 and [0083] – “The side portions may have a matrixed, latticed or meshed type of structure. As shown, the flexible side section 12 has a patterned cut-out portion to help facilitate the radial expansion and retraction function of the sleeve. To facilitate insertion and accommodate any finger girth, the general diameter of the sleeve, aided by the flexibility of the side sections, increases. However, the side sections will help resist or limit that increase, to ensure a snug fit of the sleeve about the finger and enhance the blood flow rate at the tip of the finger”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Keren to include a pair of open portions formed on respective sides of the finger cuff, as disclosed in Haines et al., so as to accommodate a wide range of finger circumferences and yet permit easy insertion, secure holding, and safe removal (see Haines et al.: [0015]).
Regarding claim 7, Haines et al. teaches each open portion further comprises a rounded end portion (see Figure 1).
Claim(s) 9, 11, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren, further in view of Faurie et al. (US Publication No. 2015/0351676 A1) (previously cited).
Regarding claim 9, Keren discloses a kit for capillary blood sample collection, the kit comprising:
a lancet (35) (see col. 4, lines 20-23 – “Puncturing unit 30, comprising a lancing element 35, is accessible from the external surface of body 12 and is provided with a self return mechanism”); and
a sterile finger cuff device comprising:
a finger cuff comprising:
an open end portion (14) sized to accommodate a user's finger see Figures 1-3 and col. 4, lines 9-11 – “Thimble body 12 is open at one end 14 for receiving a finger 5 and is preferably closed at the opposite end 16”),
a finger stop end portion (20) opposite the open end portion (see Figures 3-4 and col. 4, lines 28-31 – “A stopper wall 20 located at a predetermined distance from opening 14 adjusts the position of finger 5 in relation to puncturing unit 30 by preventing the finger from penetrating further into the body cavity”),
an outer sidewall (see Figures 1-4),
an inner sidewall (see Figures 3-4), and
at least one lancet guide opening (25) formed through the outer sidewall and inner sidewall (see Figures 3-4 and col. 4, lines 40-41 – “A small opening 25 in wall 12 allows lancet 35 when fired to penetrate through wall 12 into finger tip 4”); and
at least one integrated absorbent pad (17, 19, 50) positioned on the inner sidewall of the finger cuff (see Figures 3-4 and col. 4, line 60-col. 5, line 2 – “A wick member 19, having one end in contact with the inner surface of membrane 17 and a second end in contact with the sample receiving zone of strip 50 may optionally be added to serve as a bridging element between the two. Wick member 19 may be made of glass fiber, polyester or other filter material known in the art. Alternatively, sample receiving end 52 may be in direct contact with membrane 17 or may be positioned on top of membrane 17 directly below lancet 35 such that blood is directly applied on the sample receiving zone”),
wherein the at least one lancet guide opening is positioned off-center from a centerline of the finger cuff (see Figure 3 and annotated version above) and the at least one integrated absorbent pad is aligned in-line with the at least one lancet guide opening relative to the centerline (see Figure 4; element 17 aligned with opening 25).
It is noted Keren does not specifically teach a microtainer collection tube; at least one sterile wipe; or a bandage. However, Faurie et al. teaches a microtainer collection tube (see [0037] – “The blood collection receptacle is preferably a vacuum tube such as a VACUTAINER tube available from Becton, Dickinson & Company, or a similar generic model”); at least one sterile wipe (266) (see [0049] – “In FIG. 7A, the finger 10 is placed on the receptacle 261 and a dispenser 265, adapted to dispense a sanitizing agent 266 on a portion of a finger 10 of a patient placed within the insertion port, sprays a sanitizing agent 266 onto the finger 10”); and a bandage (see [0033] – “a dressing mechanism 251 comprising a bandage 252 for bandaging a punctured finger”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Keren to include a microtainer collection tube, at least one sterile wipe, and a bandage, as disclosed in Faurie et al., so as to sanitize a portion of the finger, collect a predetermined amount of blood from the pierced finger in the microtainer collection tube, and then bandage the pierced finger (see Faurie et al.: [0011]).
Regarding claim 11, Keren discloses the at least one lancet guide opening is positioned proximate the finger stop end portion of the finger cuff (see Figures 3-4).
Regarding claim 16, Keren discloses the finger cuff is formed of an elastic material (see col. 4, lines 12-15 – “Preferably body 12 is fabricated from low-cost sterilizable plastic material such as PET (polyethylene), polystyrene and the like by a mold injection process”).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren and Faurie et al., further in view of Yeoh et al.
Regarding claim 12, it is noted Keren does not specifically teach the at least one lancet guide opening is elongated relative to a longitudinal axis of the finger cuff. However, Yeoh et al. teaches the at least one lancet guide opening (9) is elongated relative to a longitudinal axis of the finger cuff (3) (see Figure 1B and [0017] – “The lancet insertion aperture (9) is longer than the lancet disposition aperture (8)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Keren and Faurie et al. to include the at least one lancet guide opening is elongated relative to a longitudinal axis of the finger cuff, as disclosed in Yeoh et al., so as to guide the lancet into the device.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keren and Faurie et al., further in view of Haines et al.
Regarding claim 14, it is noted Keren does not specifically teach a pair of open portions formed on respective sides of the finger cuff. However, Haines et al. teaches a pair of open portions (12) formed on respective sides of the finger cuff (see Figure 1 and [0083] – “The side portions may have a matrixed, latticed or meshed type of structure. As shown, the flexible side section 12 has a patterned cut-out portion to help facilitate the radial expansion and retraction function of the sleeve. To facilitate insertion and accommodate any finger girth, the general diameter of the sleeve, aided by the flexibility of the side sections, increases. However, the side sections will help resist or limit that increase, to ensure a snug fit of the sleeve about the finger and enhance the blood flow rate at the tip of the finger”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Keren and Faurie et al. to include a pair of open portions formed on respective sides of the finger cuff, as disclosed in Haines et al., so as to accommodate a wide range of finger circumferences and yet permit easy insertion, secure holding, and safe removal (see Haines et al.: [0015]).
Regarding claim 15, Haines et al. teaches each open portion further comprises a rounded end portion (see Figure 1).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faurie et al., further in view of Keren.
Regarding claim 17, Faurie et al. discloses a method of capillary blood sample collection, the method comprising:
preparing a finger and desired puncture site for blood sample collection with a sterilized wipe (see [0050] – “At block 302, a portion of the finger of the patient is sanitized within the automatic blood collection apparatus”);
placing a sterile finger cuff device over the prepared finger at the desired puncture site, the sterile finger cuff device comprising:
a finger cuff (200) comprising:
an open end portion (260) sized to accommodate a user's finger (see Figure 2A and [0033] – “an insertion port 260 for receiving a finger of a patient”),
a finger stop end portion opposite the open end portion (see Figure 6A),
an outer sidewall (see Figures 6-6A),
an inner sidewall (see Figures 6-6A), and
at least one lancet guide opening (262) formed through the outer sidewall and inner sidewall (see Figure 6A and [0036] – “The lancet is preferably positioned near the internal end of the insertion port 262” and [0046] – “As the actuator 254 is pushed downward, towards the finger 10, the needle contained within the disposable container 261 pricks the finger 10 and the strip 259 is pulled outwards to remove the first drop of blood”); and
at least one absorbent pad (259) (see Figure 2A and [0033] – “a strip 259 for removing a first drop of blood”);
pressing a lancet through the at least one lancet guide opening to puncture the finger at the desired puncture site (see Figure 6A and [0046] – “As the actuator 254 is pushed downward, towards the finger 10, the needle contained within the disposable container 261 pricks the finger 10 and the strip 259 is pulled outwards to remove the first drop of blood”); and
removing the sterile finger cuff device from the finger to expose the puncture site and wipe away a first blood drop from the puncture site via the at least one integrated absorbent pad of the sterile finger cuff device (see [0049] – “The next step, wiping the first drop of blood is not shown within FIGS. 7-7C as the mechanism 259 may be a separate component, and not be a component of the receptacle 261”).
It is noted Faurie et al. does not specifically teach the absorbent pad is at least one integrated absorbent pad positioned on the inner sidewall of the finger cuff, wherein the at least one lancet guide opening is positioned off-center from a centerline of the finger cuff and the at least one integrated absorbent pad is aligned in-line with the at least one lancet guide opening relative to the centerline. However, Keren teaches at least one integrated absorbent pad (17, 19, 50) positioned on the inner sidewall of the finger cuff (see Figures 3-4 and col. 4, line 60-col. 5, line 2 – “A wick member 19, having one end in contact with the inner surface of membrane 17 and a second end in contact with the sample receiving zone of strip 50 may optionally be added to serve as a bridging element between the two. Wick member 19 may be made of glass fiber, polyester or other filter material known in the art. Alternatively, sample receiving end 52 may be in direct contact with membrane 17 or may be positioned on top of membrane 17 directly below lancet 35 such that blood is directly applied on the sample receiving zone”), wherein the at least one lancet guide opening is positioned off-center from a centerline of the finger cuff (see Figure 3 and annotated version above) and the at least one integrated absorbent pad is aligned in-line with the at least one lancet guide opening relative to the centerline (see Figure 4; element 17 aligned with opening 25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Faurie et al. to include the absorbent pad is at least one integrated absorbent pad positioned on the inner sidewall of the finger cuff, wherein the at least one lancet guide opening is positioned off-center from a centerline of the finger cuff and the at least one integrated absorbent pad is aligned in-line with the at least one lancet guide opening relative to the centerline, as disclosed in Keren, so as to directly apply the blood to the absorbent pad (see Keren: col. 4, line 66-col. 5, line 2).
Regarding claim 18, Faurie et al. teaches collecting a blood sample in a microtainer tube after the first blood drop is wiped away from the puncture site via the at least one integrated absorbent pad of the sterile finger cuff device (see [0049] – “FIG. 7C shows the blood collection into a capillary tube 255, for collecting a predetermined amount of blood”).
Regarding claim 19, Faurie et al. teaches closing the microtainer tube after collection of a desired volume of blood sample (see [0037] – “In a preferred embodiment, a transport mechanism transports the blood collection receptacle containing blood to a blood analyzer. The blood collection receptacle is preferably a vacuum tube such as a VACUTAINER tube available from Becton, Dickinson & Company, or a similar generic model. Preferably, the blood collection receptacle contains up to ten milliliters of blood, and alternatively contains from 1 milliliter to 10 milliliters of blood from the patient”) and bandaging the puncture site on the finger (see [0033] – “a dressing mechanism 251 comprising a bandage 252 for bandaging a punctured finger”).
Regarding claim 20, Faurie et al. teaches placing the sterile finger cuff device over the prepared finger comprises placing the finger cuff on the finger such that the at least one lancet guide opening is positioned off-center of a centerline of the finger (see Figure 6A). Keren also teaches placing the sterile finger cuff device over the prepared finger comprises placing the finger cuff on the finger such that the at least one lancet guide opening is positioned off-center of a centerline of the finger (see Figures 1-4).
Response to Arguments
Applicant's arguments filed 4/1/2026 have been fully considered but they are not persuasive.
Applicant argues that Keren does not disclose the at least one lancet guide opening positioned off-center from a center line of the finger cuff and the at least one integrated absorbent pad is aligned in-line with the at least one guide opening relative to the centerline, as now recited in the amended claims. The Examiner respectfully disagrees and notes that under the broadest reasonable interpretation, there are multiple center lines of the finger cuff in Keren that the lancet guide opening (25) is offset from. In particular, an annotated version of Keren demonstrates two such center lines and clearly shows opening being off-center relative thereto. Moreover, Figure 4 of Keren shows absorbent pad 17 being aligned with the lancet guide opening, while other absorbent pads 19, 50 are also in-line with the at least one guide opening relative to at least one of the shown center lines. Accordingly, Keren still reasonably maps to the language of Applicant’s amended claims 1, 9, and 17.
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gu (US Publication No. 2006/0047221 A1) establishes that the ideal lancing site is off the center of the finger pad.
Kew (US Publication No. 2023/0147679 A1) discloses a finger cuff with an integrated absorbent pad for wiping away the first drop of blood that can include cell tissue contaminants, and thereafter collecting a blood sample in a capillary collection device.
THIS ACTION IS MADE FINAL. 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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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