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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-4, 6-10, 12-15, 17-21, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0216380 A1 to Ivosevic et al. (“Ivosevic”).
Regarding Claim 1, Ivosevic discloses a device for obtaining a blood sample (Abstract), the device comprising:
a holder for receiving a sample source (holder 12 receives a finger that supplies a blood sample, Para. [0060]; Fig. 10), the holder having an actuation portion (actuation portion 24, Fig. 2) and a port (port 26, Fig. 2);
a container engagement portion connected to the holder (container engagement portion 72 connects to holder 12 via port 26, Fig. 10); and
a collection container removably connectable to the container engagement portion (blood collector portion 74 connects to container engagement portion 72, Fig. 10; blood collector portion 74 can be removed and a cap 76 placed on it, Para. [0080]; Fig. 10), the container defining a collection cavity (blood collector portion 74 contains collection cavity 70, Fig. 10),
wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder (actuation portion 24 has wings 38 at an angle from finger 19 in holder 12, Fig. 23) to create a pressure gradient towards a fingertip of the patient's finger, and thereby direct blood flow towards the fingertip (actuation portion 24 applies pressure to a portion of finger 19, Para. [0065]; Fig. 23).
Regarding claim 2, Ivosevic discloses the device of claim 1, wherein the at least two wings are positioned on the holder at a position proximal of a fingernail of the patient's finger and distal from a first knuckle of the patient's finger (wings 38 are positioned proximal the tip of a fingernail and distal a knuckle, Fig. 23).
Regarding Claim 3, Ivosevic discloses the device of claim 1, wherein each of the at least two wings includes a touch pad that ensures a user squeezes the wings at a desired location (touch pad is space of wing 38 above ridge closest to port 26, the ridge is functionally capable of using friction to keep a user's finger or grip on the touch pad, Fig. 14).
Regarding claim 4, Ivosevic discloses the device of claim 1, wherein the holder further comprises a stability extension portion provided on a proximal end of the holder (stability extension portion 40 on a proximal end of holder 12, Fig. 10).
Regarding claim 6, Ivosevic discloses the device of claim 1, wherein at least one wing of the at least two wings includes an anti-touch protrusion that extends outwardly from an outer surface of the wings (wing 38 includes a ridge on its outer surface closest to port 26, Fig. 14).
Regarding claim 7, Ivosevic discloses the device of claim 6, wherein the anti-touch protrusion is positioned beneath a touch pad of the at least one wing to ensure a user grips the at least one wing at the touch pad and not beneath the touch pad (touch pad is space of wing 38 above ridge closest to port 26, the ridge is functionally capable of preventing a user's finger or grip from slipping beneath the touch pad, Fig. 14).
Regarding claim 8, Ivosevic discloses the device of claim 1, wherein a proximal end of the holder includes a flared edge to receive the patient's finger (proximal-most edge of stability extension portion 40 flares upward in a circular shape and receives finger 19, Fig. 27).
Regarding claim 9, Ivosevic discloses the device of claim 1, wherein a transition portion is positioned between the holder and the container engagement portion to receive at least a portion of the patient's finger during use of the device (finger end guard 30 between the majority of holder 12 and container engagement portion 72, Fig. 10; finger end guard 30 receives fingertip, Fig. 23).
Regarding claim 10, Ivosevic discloses the device of claim 1, wherein a distal end of the holder includes a curved edge to receive a patient's fingertip while allowing the patient's fingernail to extend past the distal end of the holder (curved finger end guard 30 receives fingertip but is short enough to allow a long fingernail to extend past finger end guard 30, Figs. 10 and 23).
Regarding claim 12, Ivosevic discloses a device for obtaining a blood sample (Abstract), the device comprising:
a holder for receiving a sample source (holder 12 receives a finger that supplies a blood sample, Para. [0060]; Fig. 10), the holder having an actuation portion (actuation portion 24, Fig. 2) and a port (port 26, Fig. 2); and
a container engagement portion connected to the holder (container engagement portion 72 connects to holder 12 via port 26, Fig. 10);
wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder (actuation portion 24 has wings 38 at an angle from finger 19 in holder 12, Fig. 23) to create a pressure gradient towards a fingertip of the patient's finger and thereby direct blood flow towards the fingertip (actuation portion 24 applies pressure to a portion of finger 19, Para. [0065]; Fig. 23).
Regarding claim 13, Ivosevic discloses the device of claim 12, wherein the at least two wings are positioned on the holder at a position proximal of a fingernail of the patient's finger and distal from a first knuckle of the patient's finger (wings 38 are positioned proximally the tip of a fingernail and distal a knuckle, Fig. 23).
Regarding claim 14, Ivosevic discloses the device of claim 12, wherein each of the at least two wings includes a touch pad that ensures a user squeezes the wings at a desired location (touch pad is space of wing 38 above ridge closest to port 26, the ridge is functionally capable of using friction to keep a user's finger or grip on the touch pad, Fig. 14).
Regarding claim 15, Ivosevic discloses the device of claim 12, wherein the holder further comprises a stability extension portion provided on a proximal end of the holder (stability extension portion 40 on a proximal end of holder 12, Fig. 10).
Regarding claim 17, Ivosevic discloses the device of claim 12, wherein at least one wing of the at least two wings includes an anti-touch protrusion that extends outwardly from an outer surface of the wings (wing 38 includes a ridge on its outer surface closest to port 26, Fig. 14).
Regarding claim 18, Ivosevic discloses the device of claim 17, wherein the anti-touch protrusion is positioned beneath a touch pad of the at least one wing to ensure a user grips the at least one wing at the touch pad and not beneath the touch pad (touch pad is space of wing 38 above ridge closest to port 26, the ridge is functionally capable of preventing a user's finger or grip from slipping beneath the touch pad, Fig. 14).
Regarding claim 19, Ivosevic discloses the device of claim 12, wherein a proximal end of the holder includes a flared edge to receive a patient's finger (proximal-most edge of stability extension portion 40 flares upward in a circular shape and receives finger 19, Fig. 27).
Regarding claim 20, Ivosevic discloses the device of claim 12, wherein a transition portion is positioned between the holder and the container engagement portion to receive at least a portion of the patient's finger during use of the device (finger end guard 30 between the majority of holder 12 and container engagement portion 72, Fig. 10; finger end guard 30 receives fingertip, Fig. 23).
Regarding Claim 21, Ivosevic discloses the device of claim 12, wherein a distal end of the holder includes a curved edge to receive a patient's fingertip while allowing the patient's fingernail to extend past the distal end of the holder (curved finger end guard 30 receives fingertip but is short enough to allow a long fingernail to extend past finger end guard 30, Figs. 10 and 23).
Regarding claim 23, Ivosevic discloses a device for obtaining a blood sample (Abstract), the device comprising:
a holder for receiving a sample source (holder 12 receives a finger that supplies a blood sample, Para. [0060]; Fig. 10), the holder having an actuation portion (actuation portion 24, Fig. 2) and a port (port 26, Fig. 2);
a container engagement portion connected to the holder (container engagement portion 72 connects to holder 12 via port 26 and locking portion 32, Fig. 10);
a collection container removably connectable to the container engagement portion (blood collector portion 74 connects container engagement portion 72 to locking portion 32, Fig. 10; blood collector portion 74 can be removed and a cap 76 placed on it, Para. [0080]; Fig. 10), the collection container defining a collection cavity and thereby direct blood flow towards the fingertip (blood collector portion 74 contains collection cavity 70, Fig. 10); and
a lancet device removably connected to the container engagement portion (lancet housing 14 is removably connectable to port 26 with locking portion 32, Para. [0071]; Fig. 8),
wherein the actuation portion comprises at least two wings that are angled relative to a patient's finger held in the holder (actuation portion 24 has wings 38 at an angle from finger 19 in holder 12, Fig. 23) to create a pressure gradient towards a fingertip of the patient's finger (actuation portion 24 applies pressure to a portion of finger 19, Para. [0065]; Fig. 23).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of US 7,591,791 B2 to Keren.
Regarding claim 5, Ivosevic discloses the device of claim 4.
Ivosevic fails to explicitly disclose wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder.
Keren is in the field of blood tests (Abstract) and teaches wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder (distal end of cavity 16 has rubber flange 18 which enhances gripping of the finger and keeps the finger in place, Col. 4, Lns. 31-33; Fig. 3).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ivosevic with wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder of Keren. The motivation being to stabilize the finger and thus properly draw a blood sample from a safe location on the finger.
Regarding Claim 16, Ivosevic discloses the device of claim 15.
Ivosevic fails to explicitly disclose wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder.
Keren is in the field of blood tests (Abstract) and teaches wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder (distal end of cavity
16 has rubber flange 18 which enhances gripping of the finger and keeps the finger in place, Col. 4, Lns. 31-33; Fig. 3).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ivosevic with wherein the stability extension portion includes at least one retention bump that extends inwardly from an inner surface of the stability extension portion to contact the patient's finger held in the holder of Keren. The motivation being to stabilize the finger and thus properly draw a blood sample from a safe location on the finger.
Claim(s) 11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of US 8,333,715 B1 to Alferness.
Regarding claim 11, Ivosevic discloses the device of claim 1.
Ivosevic fails to explicitly disclose wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion.
Alferness is in the field of blood glucose sampling (Abstract) and teaches wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion (a protruding on the outer grip of blood glucose sampling device 56 into the test finger 59 specifically impedes venous return but still allowing arterial flow, Col. 7, Lns. 43-59; Fig. 5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ivosevic with wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion of Alferness. The motivation being to reduce bleeding while focusing on drawing blood selectively from only the venous or arterial route.
Regarding claim 22, Ivosevic discloses the device of claim 12. Ivosevic fails to explicitly disclose wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion.
Alferness is in the field of blood glucose sampling (Abstract) and teaches wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion (a protruding on the outer grip of blood glucose sampling device 56 into the test finger 59 specifically impedes venous return but still allowing arterial flow, Col. 7, Lns. 43-59; Fig. 5).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Ivosevic with wherein the holder includes a finger receiving portion that includes at least one bulge on an outer surface of the finger receiving portion to prevent pressure on an arterial blood supply of the patient's finger held in the finger receiving portion of Alferness. The motivation being to reduce bleeding while focusing on drawing blood selectively from only the venous or arterial route.
Response to Arguments
Applicants’ arguments filed June 18, 2026 have been fully considered but they are not persuasive.
Applicants argues that Ivosevic fails to disclose or suggest wings angled relative to the patient’s finger to create a pressure gradient towards the patient’s fingertip and thereby direct blood flow towards the fingertip. But the only structure recited in this aspect of the invention is “at least two wings that are angled relative to a patient's finger held in the holder.” This is what Ivosevic discloses.
Applicants’ specification explains how the structure produces the gradient. “The angle of the wings 38 relative to the natural taper of the finger 19 creates a small pressure gradient from distal to proximal end of the finger 19, ensuring the direction of flow is towards the fingertip while avoiding finger milking per international best practices for sample quality.” See Specification at [0070]. The gradient therefore results from squeezing the wings against a finger that naturally tapers. Neither the claims nor the specification require any wing geometry beyond this.
Ivosevic discloses the same structure. Its holder 12 has the same finger receiving portion 20, actuation portion 24, pumping member 36, pair of opposed wings 38 joined by a living hinge 42, stability extension portion 40, port 26, and finger end guard 30 as Applicants’ holder (compare Ivosevic Figs 1-3, 21, and 23 with Applicants’ Figs 1-5). It further appears that Ivosevic was similarly concerned with this milking problem (see [0006] -- …” (3) inconsistent squeezing technique and excessive pressure near the lancing site to promote blood extraction (e.g., blood milking) which could potentially result in a hemolyzed sample… .”
Where the claimed and prior art products are identical or substantially identical in structure, the claimed properties or functions are presumed to be inherent (see MPEP 2112.01(I)). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In this case, Applicant has not identified any structural difference between the wings of Ivosevic and the claimed invention that would result in anything other than “a pressure gradient towards a fingertip of the patient's finger to thereby direct blood flow towards the fingertip” from squeezing the wings.
Applicants’ arguments regarding Keren and Alferness rely on the alleged deficiency of Ivosevic and are not persuasive for the reasons above.
Conclusion
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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791
