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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/04/2025 and 07/21/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election with traverse of invention (I), species (16) and further species (a) drawn to claims 1 and 15-19, and claim 2-14 and 20-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/05/2025.
Response to Arguments
Applicant’s arguments with respect to there is no search burden to examine all inventions and species have been fully considered but are not persuasive, because the different inventions and species are directed to distinct inventions and embodiments having various structural elements that requires different modes of operation that will cause a serious search and/or examination burden.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “positioned to be contacted by blood” in lines 9 should be amended to read –configured to be positioned to be contacted by blood--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “and/or” in line 10 should be amended to read –and--, or –or--, because the phrase “and/or” render the claims indefinite because it is unclear what constitutes the metes and bounds of the invention. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “to be mixed with the blood” in line 11 should be amended to read –configured to be mixed with the blood--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bokka Srinivasa Rao (US 2019/0223772).
As to claim 1, Bokka Srinivasa Rao teaches a sample collection container (container 14, par.57, fig.1 and 11) configured to be removably mounted to a blood collection device (blood collection device, 10, par.57, fig.1 and 11), the sample collection container comprising:
a housing comprising a first end, a second end, a flow channel (housing 12 defines a centerline CL and includes a first end 20, a second end 22, and a flow channel 24, par.58, ffg.1 and 11) having an inlet and an outlet extending at least partially between the first end and the second end of the housing (flow channel 24 includes an inlet 26 and an outlet 28, par.58, fig.1 and 11);
a container body (body of container 14, par.57-58, fig.1 and 11) removably connected to the second end of the housing (collection container 14 of the present disclosure is removably connectable to the housing 1, par.59 and par.79, fig.1 and 11) comprising an open top (open top of container 14 connected to second end 222 of housing 12, par.559, fig.1, 2 and 11), a closed bottom (bottom closed end of container 14, fig.1, 2 and 11), and an interior wall extending between the top and the bottom, which define a collection cavity (interior wall surface 72 defining collection cavity 70, par.59, fig.1, 2 and 11),
wherein, when the housing is connected to the container body, the outlet of the flow channel is in fluid communication with the collection cavity (the container 14 connected to the housing 12, the outlet 28 of the flow channel 24 is in fluid communication with the collection cavity 70 of the container 14, par.59, fig.1, 2 and 11); and
at least one additive dispersing object (sample stabilizer 200, par.107, fig.11-16) positioned to be contacted by blood flowing from the blood collection device through the flow channel and/or into the collection cavity (stabilizer 200 is placed in channel 24 to be contacted with sampled blood flowing into cavity 70, par.107-109, fig.11),
the at least one additive dispersing object comprising an additive composition to be mixed with the blood passing along the flow channel and into the collection cavity (sample stabilizer 200 can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element, par.107-109, fig.11-17).
As to claim 15, Bokka Srinivasa Rao teaches the sample collection container, wherein the at least one additive dispersing object comprises a molded part comprising an exterior surface coated by the additive composition (mold of foamed stabilizer 200 having various shapes, as best seen in fig.12-16, wherein stabilizer 200 comprises a floating anticoagulant coated open cell foam material 220, par.112-114).
Allowable Subject Matter
Claims 16-19 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 5712725596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791