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 Objections
Claims 17-19 are objected to because of the following informalities: the claims are grammatically incorrect. The Office recommends adding “the method includes” after “wherein”. Appropriate correction is required.
Claims 17 is objected to because of the following informalities: “oxygen” was already previously presented in claim 15. The Office recommends changing it to “the oxygen.” Appropriate correction is required.
Claim 18 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 15. The limitation “treating the modified inner surface with an anticoagulant” is already present in claim 15. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 19 is objected to because of the following informalities: the Specification describes that the anticoagulant may be a coating in [0024], but the claim recites treating the inner surface with both “an anticoagulant” and “a coating.” The Office recommends amending to state that the anticoagulant presented in claim 15 is a coating to properly reflect the present disclosure. Appropriate correction is required.
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, 4-8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6155991 (herein Beat) in view of US 20100209292 (herein Hayashi).
Regarding claim 1, Beat teaches A blood collection device (blood sample collection apparatus 10, Col. 2, Lines 65), comprising:
a plastic tube having a first open end, a second open end opposite the first open end, and a sidewall which together define an elongated collection body (capillary tube 12, Col. 3, Line 3; polycarbonate material, Col. 3, Line 15; Fig. 1),
wherein the interior wall surface area of the elongated collection body is treated with an anticoagulant to enhance capillary action (a coating of sodium heparin or advanced heparin can be formed on surfaces of capillary tube 12, or impregnated in capillary tube 12, to prevent clotting of blood contained in capillary tube 12, Col. 3, Lines 21-24).
Further regarding claim 1, Beat does not teach, “wherein an interior wall surface area of the elongated collection body is treated with a plasma generated from a gas containing oxygen, whereby the plasma-treated interior wall surface area is modified by inducing a low-pressure environment to allow plasma ions to travel a length of the elongated collection body.” However, Hayashi teaches it is known in the art to treat a tubule 1 with plasma from a gas containing oxygen ([0100]), and adjusting pressure inside the tubule to a higher or lower level than outside the tubule ([0080]) to discharge the gas ([0087]).
Regarding claim 2, Hayashi teaches wherein the induced low-pressure is approximately 0.1 mbar or less (internal pressure is set within a range of 100 Pa [1 mbar], external pressure is 1/10 [0.1 mbar] or less, [0081]).
Regarding claim 4, Beat teaches wherein at least one of the first open end or the second open end includes a flared portion that is configured to receive a plug (Fig. 12 teaches tube 12 having end cap 14 with tapered portion 30 received in opening , which corresponds to flared portion of the present invention; and plug 20, see Col. 3, Lines 53-54).
Regarding claim 5, Hayashi teaches wherein the elongated collection body is approximately 75 mm in length ([0023] teaches tubule having a length of 10 cm, which is interpreted as approximately 75 mm). Furthermore, it would be obvious to one of ordinary skill in the art to optimize tube length to suit apparatus usage. Based on MPEP 2144.05 II, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Note that according to § MPEP 2144, “Office personnel may invoke legal precedent as a source of supporting rationale when warranted and appropriately supported.”
Regarding claim 6, Beat teaches wherein the plastic hematocrit tube is made from polycarbonate (tube 12 can be of a known construction and can be formed of a polycarbonate material, Col. 3, Lines 15-16).
Regarding claim 7, Beat teaches A blood collection assembly (blood sample collection apparatus 10, Col. 2, Lines 65), comprising:
a plastic hematocrit tube having a first open end, a second open end opposite the first open end, and a sidewall which together define an elongated collection body (capillary tube 1, Col. 3, Line 3; polycarbonate material, Col. 3, Line 15; Fig. 1),
wherein the interior wall surface area of the elongated collection body is treated with an anticoagulant to enhance capillary action (a coating of sodium heparin or advanced heparin can be formed on surfaces of capillary tube 12, or impregnated in capillary tube 12, to prevent clotting of blood contained in capillary tube 12, Col. 3, Lines 21-24); and
a plug configured to be inserted in one of the first end open end or the second open end (plug 20, Col. 3, Line 30).
Further regarding claim 7, Beat does not teach, “wherein an interior wall surface area of the elongated collection body is treated with a plasma generated from a gas containing oxygen, whereby the plasma-treated interior wall surface area is modified by inducing a low-pressure to allow plasma ions to travel a length of the elongated collection body.” However, Hayashi teaches it is known in the art to treat a tubule 1 with plasma from a gas containing oxygen ([0100]), and adjusting pressure inside the tubule to a higher or lower level than outside the tubule ([0080]) to discharge the gas ([0087]).
Regarding claim 8, Hayashi teaches wherein the applied low-pressure is approximately 0.1 mbar or less (internal pressure is set within a range of 100 Pa [1 mbar], external pressure is 1/10 [0.1 mbar] or less, [0081]).
Regarding claim 10, Beat teaches wherein at least one of the first open end or the second open end includes a flared portion that is configured to receive the plug (Fig. 12 teaches tube 12 having end cap 14 with tapered portion 30 received in opening , which corresponds to flared portion of the present invention; and plug 20, see Col. 3, Lines 53-54).
Regarding claim 11, Hayashi teaches wherein the elongated collection body is approximately 75 mm in length ([0023] teaches tubule having a length of 10 cm, which is interpreted as approximately 75 mm). Furthermore, it would be obvious to one of ordinary skill in the art to optimize tube length to suit apparatus usage. Based on MPEP 2144.05 II, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382. Note that according to § MPEP 2144, “Office personnel may invoke legal precedent as a source of supporting rationale when warranted and appropriately supported.”
Regarding claim 12, Beat teaches wherein the plastic hematocrit tube is made from polycarbonate (tube 12 can be of a known construction and can be formed of a polycarbonate material, Col. 3, Lines 15-16).
For the above claims 1-2, 4-8, and 10-12, it would have been obvious to one of ordinary skill in the art before the time of filing to incorporate the plasma treatment of Hayashi into the blood sample collection apparatus of Beat. One would be motivated to do so for at least the purpose of sterilizing the device and preventing damage to the tube ([0008]).
Claim(s) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beat and Haysashi as applied to claims 1 and 7 above, and further in view of US 20230098565 (herein Arrigo).
Regarding claim 3 and 9, Beat teaches the use of sodium heparin, but does not teach, “wherein the anticoagulant is ammonium heparin.” However, Arrigo teaches it is known in the art to use ammonium heparin as an anticoagulant ([0112]). It would be obvious to one of ordinary skill in the art to simply substitute sodium heparin of Beat with ammonium heparin of Arrigo because both serve as anticoagulant treatment in blood collection tubes ([0112]). The above findings satisfies the Graham factual inquiries stated in MPEP 2143 B regarding simple substitution of one known element for another to obtain predictable results.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beat and Haysashi as applied to claim 7 above, and further in view of Non-Patent Literature titled, “A Model of Individualized Instruction for the Clinical Laboratory Occupations” (herein Taub).
Regarding claim 13, Beat does not teach, “wherein the plug is a clay based self-sealant plug.” However, Taub teaches it is well known in the art to seal a distal end of a capillary tube for blood using a clay plug (p. 24). It would have been obvious to one of ordinary skill in the art to simply substitute the material of plug 20 of Beat with clay taught by Taub because both perform the function of preventing fluid from a capillary tube from escaping. The above findings satisfies the Graham factual inquiries stated in MPEP 2143 B regarding simple substitution of one known element for another to obtain predictable results.
Regarding claim 14, Beat teaches wherein the plug includes at least one channel defining a passageway for extracting vapor contained in the tube (end cap 14 in Col. 3, Line 2 and Fig. 1-2 may correspond to plug of the present invention, which functions to close an end of tube 12 that features has passage 24 that extends therethrough to evacuate contents).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi in view of Beat.
Regarding claims 15 and 18, Hayashi teaches A method for modifying an interior surface of a blood collection device, comprising:
placing a plastic
subjecting the plastic
providing a low-pressure environment within the plasma discharge apparatus, whereby the low-pressure environment allows plasma ions to travel a length of an inner surface of the plastic
Further regarding claims 15 and 18, Hayashi teaches examples of the tubule used for catheters but does not explicitly teach tube is used for hematocrit. However, Beat teaches tubes including those used for blood collection from capillaries (Col. 4, Line 27). Additionally, Hayashi does not teach, “treating the modified inner surface with an anticoagulant for enhanced capillary action.” However, Beat teaches it is known in the art to coat a capillary tube with sodium heparin or advanced heparin to prevent clotting of blood contained in capillary tube (Col. 3, Lines 21-24).
Regarding claim 16, Hayashi teaches wherein the low-pressure is applied at approximately 0.1 mbar or less (internal pressure is set within a range of 100 Pa [1 mbar], external pressure is 1/10 [0.1 mbar] or less, [0081]).
Regarding claim 17, Hayashi teaches wherein subjecting oxygen to the plastic hematocrit tube for approximately 5 min (Discharge was carried out for 5 minutes, [0123]).
Regarding claim 19, Hayashi does not teach, “treating the modified inner surface with a coating for enhanced capillary action.” However, Beat teaches it is known in the art to coat a capillary tube with sodium heparin or advanced heparin to prevent clotting of blood contained in capillary tube (Col. 3, Lines 21-24).
For the above claims 15-19, it would have been obvious to one of ordinary skill in the art before the time of filing to incorporate the coating of Beat into the tubule of Hayashi. One would have been motivated to do so for at least the purpose of preventing blood clotting within the tube (Col. 3, Line 23-24). Additionally, it would have been obvious to one of ordinary skill in the art to simply substitute the tubule 1 of Hayashi with the capillary tube 12 of Beat because both function as blood collection apparatus and would benefit from sterilization. The above findings satisfies the Graham factual inquiries stated in MPEP 2143 B regarding simple substitution of one known element for another to obtain predictable results.
Conclusion
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/WALTER L LINDSAY JR/Supervisory Patent Examiner, Art Unit 2852
/PHILIP T FADUL/Examiner, Art Unit 2852
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