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 .
Status of Claims
Claims 1, 3, and 6-10 are currently pending. Claim 1 is currently amended. Claims 2 and 4-5 are cancelled. No new subject matter is added.
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.
Claims 1, 3, 6-7 and 9-10 are rejected under are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sekisui Chemical (JP 4914115 B2, English translation provided by Applicant in IDS filed on 9/6/2023).
Regarding Claim 1, Sekisui teaches a blood collection container (blood test container 1; see Figures 1 and 2) comprising:
a blood collection container main body (tubular container 2) having an opening at one end thereof (opening 2a) and a closed bottom at an other end thereof (2b);
a serine protease disposed in the blood collection container main body (a blood coagulation promoter containing β-alanine is housed, the blood coagulation promoter contains an enzyme including include serine proteases such as trypsin, thrombin, and snake venom thrombin-like enzymes, see Pg. 4 paragraph 7); and
a heparin neutralizing agent disposed in the blood collection container main body (anticoagulant component neutralizing agent comprising a heparin neutralizing agent such as include amine salts, organic compounds having quaternary nitrogen, protamine sulfate, and the like, and these are particularly suitable as a heparin neutralizing agent that neutralizes heparin, see pg. 7 paragraph 4),
wherein the serine protease is attached onto an inner wall surface of the blood collection container main body (the blood coagulation promotor is applied to an inner surface of the tubular wall, see claim 6),
wherein the heparin neutralizing agent is attached onto the inner wall surface of the blood collection container main body (the anticoagulant component neutralizing agent may be added to the blood coagulation promoter and housed in the tubular container, see pg. 7 paragraph 4; therefore overlapping the entire wall region that serine protease is disposed on the inner wall),
and
wherein, when a first region is a region which the serine protease is disposed (the blood coagulation promotor is applied to an inner surface of the tubular wall, see claim 6; a top half of the inner wall surface), a second region is a region in which the heparin neutralizing agent is disposed (in addition, the anticoagulant component neutralizing agent may be added to the blood coagulation promoter and housed in the tubular container, see pg. 7 paragraph 4; a bottom half of the inner wall surface) and the second region includes a portion arranged on a side of the other end of the blood collection container main body with respect to the first region (it is understood that the first a second region can be completely overlapping and thus the heparin neutralizing agent can also be arranged on the bottom half of the inner wall surface).
Regarding Claim 3, Sekisui further teaches an inorganic powder disposed in the blood collection container main body (It is preferable that an adsorptive inorganic substance is further accommodated in the tubular container, see pg. 6 paragraph 7),
Regarding Claim 6, Sekisui further teaches the inorganic powder being silica powder (silica can be the adsorptive inorganic substance, see pg. 6 paragraph 7).
Regarding Claim 7, Sekisui further teaches the serine protease being thrombin, a thrombin-like enzyme, or a fibrinogen degrading enzyme (examples of the enzymes include serine proteases such as thrombin, see pg. 4 paragraph 7).
Regarding Claim 9, Sekisui further teaches a serum separating composition housed at the bottom in the blood collection container main body (in order to efficiently collect test serum, a serum separating agent or the like may be further accommodated in the tubular container, see pg. 8 line 3).
Regarding Claim 10, Sekisui further teaches wherein the inorganic powder is attached onto the inner wall surface of the blood collection container main body (the adsorptive inorganic substance may be added to the blood coagulation accelerator and accommodated in the tubular container, see pg. 6 paragraph 7; the blood coagulation promotor is applied to an inner surface of the tubular wall, see claim 6).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sekisui Chemical (JP 4914115 B2) in view of Inoue et al. (WO 2010024325 A1), hereinafter referred to as “Inoue”.
Regarding Claim 8, Sekisui teaches all of the limitations of claim 1. However, Sekisui does not explicit disclose an antifoaming agent disposed at least at the bottom in the blood collection container main body.
Inoue teaches a blood collection container (1, see Figures 1a-b) houses a blood coagulation promoter (4) that promotes blood coagulation and an antifoaming agent (antifoaming agent-containing composition 5) disposed at least at the bottom in the blood collection container main body (applied on the entire inner surface 2c of the tubular container 2, see Figure 1a).
Sekisui and Inoue are analogous art because all deal with a blood collection container.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the blood collection container of Sekisui and further include an antifoaming agent disposed at the bottom of the main body, as taught by Inoue. Inoue teaches a blood collection container that can coagulate blood in a short amount of time and can inhibit blood coagulation in a state of containing air bubbles and generation of bubbly blood clots when blood is collected into the blood collection container (see Abstract).
Response to Arguments
Applicant's arguments filed 10/07/2025 have been fully considered but they are not persuasive.
Specifically, Applicant argues that Sekisui fails to disclose “the second region includes a portion arranged on a side of the other end of the blood container main body with respect to the first region”.
The examiner respectfully disagrees with the applicant that Sekisui fails to teach “the second region includes a portion arranged on a side of the other end of the blood container main body with respect to the first region”. Sekisui teaches the heparin neutralizing agent may be added to the serine protease and then applied to the inner wall of the blood collection container. The claim only requires the first region to be “a region” where serine protease is disposed and the second region to be “a region” where heparin neutralizing agent is disposed. Therefore, it would still be reasonable to interpret the first region as a top half of the inner wall surface and the second region as the second bottom half of inner wall surface. The claim limitation does not limit the regions for containing both components and therefor can still be interpreted to have separate regions. Claim 1 would still be rejected in view of Sekisui. Claim 8 would remain rejected for the same reasons.
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 ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (1/29/2025)Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781