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 .
Election/Restrictions
Applicant's election with traverse of Species B in the reply filed on 8/31/2026 is acknowledged. The traversal is on the ground(s) that the only difference between the species is the additional venting feature and search for features of Species B would be discovered for Species A. This is not found persuasive because the additional venting feature is divergent subject matter and would require employing different search terms and queries.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-13 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/31/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 14-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “a capillary blood collection device comprising a body defining an internal chamber and comprising” renders the claim indefinite. The two instances of “comprising” are confusing. The preamble first states that the capillary blood collection device comprises a body that defines a chamber, but the second instance of comprising makes it unclear if the first end, the second end, the port, etc. “comprise” the blood collection device and/or if the “body” and internal chamber “comprise” the blood collection device. For purposes of examination the indefinite limitation has been deemed to claim a blood collection device comprises a body defining an internal chamber, where the body comprises a first end and a second end.
Regarding claim 1, the limitation “the first end of the body” and “the second end of the body” lack proper antecedent basis. The body is never previously claimed as explicitly having a first end and a second end, especially with the confusion of what the first and second ends are part of. For purposes of examination the indefinite limitation has been deemed to claim a blood collection device comprises a body defining an internal chamber, where the body comprises a first end and a second end.
Regarding claim 1, the limitation “and providing access to the internal chamber” renders the claim indefinite because it is unclear if the port, the first end or the second end provide this access. For purposes of examination the indefinite limitation has been deemed to claim that the port provides access.
Regarding claim 1, the limitation “the body opposite from the first end” lacks proper antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim that second end is opposite the first end, relative to the body.
Regrading claim 1, the limitation where “the body defines an opening” and “the body opposite” render the claim indefinite. The preamble appears to set forth that “a body” defines an internal chamber and comprises, later in the claim, “the body”. It is unclear if the body comprises itself, or if this is some other body.
Regarding claim 10, the limitation “the opening in the first end” lacks proper antecedent basis. While claim 1 sets forth that the first end has an opening, the claim never sets forth that the opening is “in” the first end.
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) 1-11, 14-16 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 4323067 A to Adams.
Regarding claim 1, Adams discloses capillary blood collection device (apparatus 10) comprising inter alia a body (conduits 16, 18, squeeze bulb 14, coupling 20, housing 12) defining an internal chamber (interior of conduits 16, 18, squeeze bulb 14, coupling 20, housing 12) and comprising:
a first end (lower end of conduit 18 at coupling 20);
a second end (squeeze bulb 14); and
a port (conduit 16 and housing 12) between the first end and the second end (conduit 16 and housing 12 are located between the first end and second end, see FIG. 1) and providing access to the internal chamber between the first end and the second end (conduit 16 and housing 12 provide access conduit 18, squeeze bulb 14, and coupling, FIG. 1), wherein the first end of the body defines an opening into the internal chamber (coupling 20), and wherein the second end of the body opposite from the first end is compressible (squeeze bulb 14).
Regarding claim 2, Adams discloses the capillary blood collection device of claim 1, wherein the body is self-venting (compression of squeeze bulb 14 expels air from conduits 16, 18 through housing 12, and squeeze bulb 14 returning to its original shape to develop a partial vacuum, especially broadly claimed, is self-venting).
Regarding claim 3, Adams discloses the capillary blood collection device of claim 1, wherein the body comprises a compressible material (col. 6, lines 24-37).
Regarding claim 4, Adams discloses the capillary blood collection device of claim 1, wherein the capillary blood collection device is monolithic (apparatus 10 is a complete, single device, as seen in FIG. 1).
Regarding claim 5, Adams discloses the capillary blood collection device of claim 1, wherein a center axis of the port is perpendicular to a center axis of the internal chamber (the center axis of conduit 16 is perpendicular to center axis of conduit 18, FIG. 1).
Regarding claim 6, Adams discloses capillary blood collection device of claim 1, wherein the capillary blood collection device is adhesive-free (the disclosure of Adams does not address any type of adhesive) and wherein the body comprises a material such that the first end is configured to conform and adhere to a skin surface of a user via vacuum (col. 4, lines 27-42).
Regarding claim 7, Adams discloses the capillary blood collection device of claim 1, wherein the second end is a compressible bulb (squeeze bulb 14).
Regarding claim 8, Adams discloses the capillary blood collection device of claim 1, wherein a transverse dimension of the opening is greater than a transverse dimension of the port (coupling 20 is greater in a transverse dimension than any of the dimensions of conduit 16).
Regarding claim 9, Adams discloses the capillary blood collection device of claim 1, wherein at least one of the first end or the second end further comprises an integrated valve (syringe 40 and plunger 52) (col. 5, lines 46-51).
Regarding claim 10, Adams discloses the capillary blood collection device of claim 1, further comprising a gasket (circular flange 44) on the first end, wherein the gasket defines a gasket opening (space within circular flange 44, opening into syringe barrel 22), and wherein a transverse dimension of the gasket opening is less than a transverse dimension of the opening in the first end (the space within circular flange 44 that defines the opening into syringe barrel 22 is less than the coupling 20).
Regarding claim 11, Adams discloses the capillary blood collection device of claim 10, wherein the gasket further comprises a channel defined in the gasket (threads 46).
Regarding claim 14, Adams discloses the capillary blood collection device of claim 1, further comprising a flange at the first end (rim 22), wherein the flange is configured to engage skin of a user (rim 22 is capable of engaging skin of a user).
Regarding claim 15, Adams discloses the capillary blood collection device of claim 14, further comprising at least one removal tab extending outwards from the flange (bottle 24 which is removable from rim 22 and is capable of “extending outwards from” rim 22).
Regarding claim 16, Adams discloses the capillary blood collection device of claim 1, wherein an inner surface of the body forming the internal chamber is tapered from the opening to the port (the body comprises conduits 16, 18, squeeze bulb 14, coupling 20 and housing 12, and part of the inner surface of the body, specifically the conduit 16 and housing 12, are a tapered element).
Regarding claim 18, Adams discloses a capillary blood collection device comprising a body comprising:
a first end (lower end of conduit 18 at coupling 20) for forming a seal against skin of a user and/or receiving a human finger into the capillary blood collection device;
a compressible second end (squeeze bulb 14) opposite from the first end (FIG. 1); and
a port (conduit 16 and housing 12) between the first end and the compressible second end (conduit 16 and housing 12 are located between the first end and second end, see FIG. 1), wherein the port is configured to receive a collecting accessory device (the space within and defined by conduit 16 and housing 12 are capable of receiving a collecting accessory device).
Regarding claim 19, Adams discloses the capillary blood collection device of claim 18, wherein a center axis of the port is perpendicular to a center axis of an opening at the first end (the center axis of conduit 16 is perpendicular to center axis of conduit 18, FIG. 1).
Regarding claim 20, Adams discloses the capillary blood collection device of claim 18, wherein the body comprises a self-sealing air valve (compression of squeeze bulb 14 expels air from conduits 16, 18 through housing 12, and squeeze bulb 14 returning to its original shape to develop a partial vacuum, especially broadly claimed, is self-venting).
Claim(s) 1, 17 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190216380 A1 to Ivosevic et al. (hereinafter, Ivosevic).
Regarding claim 1, Ivosevic discloses a capillary blood collection device comprising inter alia a body defining an internal chamber (finger receiving portion 20) and comprising:
a first end (stability extension portion 40);
a second end (wings 38); and
a port (port 26) between the first end and the second end (at least a portion of port 26 is located between first opening 22/stability extension portion 40 and wings 38, FIG. 10) and providing access to the internal chamber between the first end and the second end (para. 0061, “The port 26 is in communication with the finger receiving portion 20.”),
wherein the first end of the body defines an opening into the internal chamber (first opening 22), and
wherein the second end of the body opposite from the first end is compressible (para. 0065, “The living hinge portion 42 allows a user to squeeze the wings 38 between a first position (FIG. 2) and a second position (FIG. 3).”).
Regarding claim 17, Ivosevic discloses a capillary blood collection system comprising the capillary blood collection device of claim 1, a collection tube (collection 16), and a lancet (lancet 14), wherein the collection tube is removable from the port (para. 0073, “the collection container 16 and the lancet housing 14 form a single component that is removably connectable to the port 26 of the holder 12”), and wherein the lancet is removable from and/or is not integrated with the capillary blood collection device (para. 0074, “the lancet housing 14 is removably connectable to the port 26 of the holder 12”).
Regarding claim 18, Ivosevic discloses a capillary blood collection device comprising a body comprising inter alia:
a first end for forming a seal against skin of a user and/or receiving a human finger into the capillary blood collection device (stability extension portion 40);
a compressible second end opposite from the first end (wings 38); and
a port (port 26) between the first end and the compressible second end (at least a portion of port 26 is located between first opening 22/stability extension portion 40 and wings 38, FIG. 10), wherein the port is configured to receive a collecting accessory device (para. 0073, “the collection container 16 and the lancet housing 14 form a single component that is removably connectable to the port 26 of the holder 12”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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