DETAILED ACTION
Applicant’s arguments, filed 04/20/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 04/20/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claim 4. Claims 1-3 and 5-16 are pending and hereby under examination.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3 and 5-9, 13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US 20190216380 – cited by Applicant) and Bokka Srinivasa Rao (US 20190223772), hereinafter Bokka.
Regarding claims 1-3 and 5-6, Ivosevic discloses a device for obtaining a blood sample, the device comprising:
a holder for receiving a patient’s finger (Figs. 1-2, holder 12 and finger 19), the holder having an actuator and a port (Figs. 1-7B, actuation portion 24 and port 26);
a blood collector attachment removably connected to the holder (Fig. 8, collection container 16); and
a collection container removably connectable to the blood collector attachment, the container defining a collection cavity (Fig. 8, blood collector portion 74 with collection cavity 70).
With regards to the limitations of claims 1-3 and 5-6, Ivosevic discloses a blood flow channel to direct blood into the collection cavity (Fig. 19, blood flow channel 120). However, Ivosevic fails to disclose a post where it is positioned within the blood collector so as not to contact a finger, wherein the top edge of the member is shorter than the top edge of the collector attachment and comprises a guided flow path connected to the post member.
However, Bokka teaches a collection device wherein a housing contains a flow directing attachment portion (Figs. 1-2, housing 12 and flow directing attachment portion 32) that is positioned within the housing so as to be directly beneath the patient's finger to make contact with the blood sample drawn from the patient's finger (Fig. 2, flow directing attachment portion 32 under finger F and collecting blood 15; Paragraph 0063). The top edge of the flow directing attachment portion is shorter than a top edge of the housing (Figs. 1-2, flow directing attachment portion 32 shorter than edge of housing 12) and is positioned within the blood collector attachment so as not to contact the patient's finger when held in the holder (Fig. 2, not contacting the finger). A guided flow path is connected to the flow directing attachment portion for directing the blood sample from the flow directing attachment portion to the collection container (Fig. 1, flow channel 24). Ivosevic discloses wherein the blood collector attachment further comprises a transition path provided between the flow directing attachment portion and the guided flow path (Fig. 19, wherein blood flow channel 120 curves into capillary tube 110).
Bokka discusses the flow directing attachment portion useful as it provides a pillar for the blood to flow in a controlled manner (Paragraph 0063). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ivosevic to incorporate the teachings of Bokka to direct the blood flow in a controlled manner.
Regarding claim 7, Ivosevic as modified further discloses wherein the transition path has a curvature (Fig. 19, wherein blood flow channel 120 curves into capillary tube 110).
Regarding claim 8, Ivosevic as modified further disclose wherein a coating is applied to at least one of the blood collector attachment and the collection container to reduce adhesion of at least part of the blood sample thereto (Paragraph 0092, wherein the collection container 16 includes an anticoagulant to stabilize a blood sample and/or a component of a blood sample).
Regarding claim 9, Ivosevic as modified discloses using an anticoagulant as above and Bokka teaches the flow directing attachment portion as above. In combination, one of ordinary skill would necessarily apply an anticoagulant to the flow directing attachment portion to stabilize the blood sample.
Regarding claim 13, Ivosevic as modified further discloses wherein a bottom edge of the blood collector attachment has a curvature to direct the blood sample from the blood collector attachment to the collection container (Fig. 19, wherein the surface leading blood from the finger 19 to blood flow channel 120 is curved).
Regarding claim 15, Ivosevic as modified further discloses wherein the blood collector attachment defines an open channel flow path between the patient's finger and the collection container (Fig. 19, blood flow channel 120 and capillary tube 110).
Regarding claim 16, Ivosevic as modified further discloses wherein the open channel flow path comprises at least one rib (Paragraph 0074, In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 in the port 26”).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic and Bokka as applied to claim 8 above, and further in view of Taylor (US 20210015413 – cited by Applicant).
Regarding claims 10-11, while modified Ivosevic discloses a coating, modified Ivosevic fails to explicitly disclose wherein the coating is a protein coating or that a protein coating comprises bovine serum albumin.
However, Taylor teaches a method for collecting fluids wherein a portion of the fluid collection device may comprise a treated surface with proteins (Paragraph 0067, bovine serum albumin as an example of protein coating) and discusses this is useful to give the collection device anti-coagulant properties and/or hydrophilic or hydrophobic properties (Paragraph 0067). The substitution of one known anti-coagulant for another yields predictable results to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Ivosevic and Bokka with the protein coating of Taylor.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic and Bokka as applied to claims 8 and 1 above, respectively, and further in view of McHale (US 10856791 – cited by Applicant).
Regarding claim 12, while modified Ivosevic discloses a coating, modified Ivosevic fails to explicitly disclose wherein the coating is EDTA.
However, McHale teaches a bodily fluid sample collection system wherein a channel of the sample collection device includes EDTA (Col 37, lines 30-66). McHale discusses EDTA is useful as it is a non-limiting anti-coagulant (Col 22, lines 25-26). The substitution of one known anti-coagulant for another yields predictable results to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of Ivosevic and Bokka with the EDTA coating of McHale.
Regarding claim 14, Ivosevic as modified fails to explicitly disclose a vent.
However, McHale teaches a bodily fluid sample collection system wherein vents are included (Col 8, lines 24-36; Col 79, lines 1-13; Col 80, lines 47-50) and discusses vents are useful for limiting flow rate (Col 8, lines 24-36) or to allow displaced gas to escape the vessel (Col 81, lines 22-24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ivosevic to incorporate the teachings of vents of McHale.
Response to Arguments
Applicant’s arguments, see page 5, filed 04/20/2026, with respect to the claim objections have been fully considered and are persuasive. Applicant has added the full name of the acronym “EDTA” in claim 12. The objection of the claim has been withdrawn.
Examiner acknowledges Applicant’s amendment to the terms “actuation portion” and “post member” with regard to their 35 U.S.C. §112(f) invocation. In light of the amendment, these terms are no longer interpreted as laid out in the Office Action filed 02/02/2026.
Applicant's arguments, see pages 5-7, filed 04/20/2026, with respect to the 35 U.S.C. §103 rejections have been fully considered but they are not persuasive.
Applicant argues that Bokka does not teach the limitation of “wherein the post is positioned within the blood collector attachment so as not to contact the patient’s finger when the patient’s finger is received in the holder”. Examiner disagrees.
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Applicant concedes in their argument that there is clearance between the first flow directing attachment portion 32 and finger F, shown in Fig. 2 above, and Fig. 2 does not show any contact between the finger F and the first flow directing attachment portion 32. Bokka further discloses that the first flow directing attachment portion 32 “provides a pillar which the first drop of blood 16 attaches to and flows down and into the flow channel 24” (Paragraph 0063). The Examiner interprets this to mean that the pillar only contacts the blood since it is positioned under the finger to attach the first drop of blood (and subsequent blood drops) to the pillar when it bleeds from the finger. Thus, Bokka reads on this claim limitation.
The rejection above has been updated to reflect the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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