DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 01/05/2025. Claims 1-20 are pending and examined below.
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.
Claim 14 is 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 14, the claim recites “the membrane”. However “the membrane” lacks antecedent basis. As such the claim is indefinite.
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.
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.
Claim(s) 1-2, 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20130167768 A1 (hereinafter referred to as “Smith”) in view of US 3814079 A (hereinafter referred to as “Minerovic”).
Regarding claim 1, Smith, a blood sampling tube, teaches a sealing cap for a specimen tube (cap 12; paragraphs [0033]; Figure 1), comprising:
a cylindrical aperture having a top end and a bottom end, and an aperture body disposed between the top end and the bottom end (as shown in Figures 1-4), wherein the bottom end comprises a diameter suited to encompass a threaded end of a specimen tube (as shown in Figures 1-4); and
a compartment defined within the cylindrical aperture (as shown in Figures 1-4).
Smith does not explicitly teach at least one mesh side disposed on the cap, the at least one mesh side sized to prevent passing a solid material while allowing passing of a liquid material.
However, Minerovic teaches at least one mesh side, the at least one mesh side sized to prevent passing a solid material while allowing passing of a liquid material (column 3, lines 10-30). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, to have a filter as taught by Minerovic, because doing so prevents only blood liquid to pass through.
Regarding claim 2, Smith, in view of Minerovic, teaches wherein the liquid material suited to pass through the mesh side comprises human blood (column 3, lines 10-30; as taught by Minerovic).
Regarding claim 4, Smith, in view of MInerovic, teaches wherein the compartment further comprises a cylindrical shape (as shown in Figures 1-4).
Regarding claim 5, Smith, in view of Minerovic, teaches further comprising threads disposed on an inside circumference of the aperture configured to engage the threaded end of a specimen tube (as shown in Figures 1-4).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith, in view of MInerovic, as applied to claim 1 above, and further in view of US 20080241001 A1 (hereinafter referred to as “Haywood”).
Regarding claim 3, Smith, in view of MInerovic, does not explicitly teach wherein the solid material preventing from passing through the mesh side comprises a human blood stabilizer.
However, Haywood teaches wherein the solid material preventing from passing through the mesh side comprises a human blood stabilizer (paragraphs [0023], [0042]-[0043]; Figure 1). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, in view of Minerovic, to have blood stabalizers, as taught by Haywood, because doing so stabilizes blood constituents promptly after collection and preserves analytes during storage and subsequent testing.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Minerovic and Haywood.
Regarding claim 11, Smith teaches a specimen tube system (abstract), comprising:
a specimen tube having a cylindrical body with a specimen tube aperture on a tube end exposing a holding area inside the cylinder (16; paragraphs [0033]; Figure 1); and
a sealing cap engageable with the specimen tube (cap 12; paragraphs [0033]; Figure 1), having:
a cylindrical aperture having a top end and a bottom end, and an aperture body disposed between the top end and the bottom end, wherein the bottom end comprises a diameter suited to engage the specimen tube (as shown in Figures 1-4);
Smith does not explicitly teach at least one mesh side disposed on the cap, the at least one mesh side sized to prevent passing a solid material while allowing passing of a liquid material and a solid blood stabilizer disposed in the compartment sized to be prevented from passing through the at least one mesh side
However, Minerovic teaches at least one mesh side, the at least one mesh side sized to prevent passing a solid material while allowing passing of a liquid material (column 3, lines 10-30). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, to have a filter as taught by Minerovic, because doing so prevents only blood liquid to pass through.
Further, Haywood teaches wherein the solid material preventing from passing through the mesh side comprises a human blood stabilizer (paragraphs [0023], [0042]-[0043]; Figure 1). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, in view of Minerovic, to have blood stabalizers, as taught by Haywood, because doing so stabilizes blood constituents promptly after collection and preserves analytes during storage and subsequent testing.
Regarding claim 12, Smith, in view of Minerovic and Haywood, teaches further comprising: specimen tube threads disposed on an outer circumference of the specimen tube adjacent to the specimen tube aperture (as shown in Figures 1-4); and sealing cap threads disposed on an inside circumference of the sealing cap aperture configured to engage the threads of the specimen tube in a liquid-tight sealed manner (as shown in Figures 1-4).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith, in view of MInerovic and Haywood, as applied to claim 1 above, and further in view of US 20090155123 A1 (hereinafter referred to as “Williams”).
Regarding claim 13, Smith, in view of Minerovic and Haywood, does not explicitly teach further comprising a membrane disposed over the top end of the sealing cap, the membrane configured to be pierced by a pipette such that the piercing pipette may pass through the sealing cap aperture.
However, Williams teaches further comprising a membrane disposed over the top end of the sealing cap, the membrane configured to be pierced by a pipette such that the piercing pipette may pass through the sealing cap aperture (paragraphs [0227]-[0230]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, in view of Minerovic and Haywood, to have a membrane disposed on the top end of the sealing cap, as taught by Williams, because doing so maintains the tube in a sealed condition while allowing an automated pipette access without removing the sealing cap of Smith.
Regarding claim 14, Smith, in view of MInerovic and Haywood, does not explicitly teach further comprising: an automated material dispensing system having at least one pipette configured to penetrate the membrane of the pierceable plugin cap to deliver material into the specimen tube, the pipette comprising a pointed end having a diameter of no more than 7 mm.
However, Williams teaches further comprising: an automated material dispensing system having at least one pipette configured to penetrate the membrane of the pierceable plugin cap to deliver material into the specimen tube, the pipette comprising a pointed end having a diameter of no more than 7 mm (paragraphs [0117], [0120], [0230], [0239]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, in view of Minerovic and Haywood, to have an automated material dispensing system having at least one pipette, as taught by Williams, because doing so allows for the automated processing of a specimen tube.
Regarding claim 15, Smith, in view of MInerovic and Haywood, does not explicitly teach further comprising: at least one pipette configured to dispense material into specimen tubes; and an actuator configured to maneuver the pipette in and out of the specimen tube.
However, Williams teaches further comprising: at least one pipette configured to dispense material into specimen tubes; and an actuator configured to maneuver the pipette in and out of the specimen tube (paragraphs [0110], [0117], [0120], [0230], [0239]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Smith, in view of Minerovic and Haywood, to have a pipette and an actuator, as taught by Williams, because doing so allows for the automated processing of a specimen tube.
Allowable Subject Matter
Claim 16, and claims dependent thereof, are allowed.
Regarding claim 16, US 20160045187 A1 (hereinafter referred to as “Terbrueggen”) teaches a method for collecting blood in a specimen container, the method comprising collecting blood from a human at a location remote from a laboratory (paragraph [0167]); stabilizing the collected blood after collection, wherein the collection device facilitates mixing of the biological sample with additives (paragraph [0170]); and packaging and sending the collected stabilized blood to the laboratory (paragraphs [0167], [0170], [0173]).
Smith, a blood sampling tube, teaches a sealing cap for a specimen tube (cap 12; paragraphs [0033]; Figure 1), comprising: a cylindrical aperture having a top end and a bottom end, and an aperture body disposed between the top end and the bottom end (as shown in Figures 1-4), wherein the bottom end comprises a diameter suited to encompass a threaded end of a specimen tube (as shown in Figures 1-4); and a compartment defined within the cylindrical aperture (as shown in Figures 1-4).
Minerovic teaches at least one mesh side, the at least one mesh side sized to prevent passing a solid material while allowing passing of a liquid material (column 3, lines 10-30).
Haywood teaches wherein the solid material preventing from passing through the mesh side comprises a human blood stabilizer (paragraphs [0023], [0042]-[0043]; Figure 1).
However, the prior art does not teach or suggest “placing a sealing cap over a top end of the specimen tube, the sealing cap having a compartment defined by at least one mesh side disposed within the sealing cap and holding a blood stabilizer in solid form; and inverting the sealed specimen tube to cause the collected blood to permeate the compartment and mix with the stabilizer stored therein” in combination with the other limitations of the claim.
Claim 6, and claims dependent thereof, are 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.
Regarding claim 6, the prior art does not teach or suggest “further comprising a pierceable membrane disposed over the top end to cover the aperture to form a liquid tight seal, the membrane configured to be pierced by a pipette such that the piercing pipette may pass through the aperture” in combination with the other limitations of the claim.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791
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