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 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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirao (US 6503210 B1).
Regarding claim 1, Hirao discloses a sample collection device (figs. 24A-25, Abstract) comprising: a sample collection unit (blood-collection position indicator 20, figs. 24A-25) having a contact surface capable of being in contact with a surface having a sample outflow hole of a subject (“outer bottom face of the cylindrical body 241b serves as a surface 241d to be brought into contact with the skin”, col. 15 lines 27-67), a retaining space (first clip part 241b, figs. 24A-25, col. 16 lines 52-65) having an opening on the contact surface (blood collection hole 241c, figs. 24A-25), and an outer surface (as seen in figs. 24A-25, “cylindrical body”, col. 15 lines 27-67), the sample collection device (blood-collection position indicator 20, figs. 24A-25) being configured to retain in the retaining space a predetermined amount of a sample due to surface tension of the sample (“capillary phenomenon ... internal volume of the blood collection hole with consideration to factors such as surface tension and viscosity of blood”; “blood in the range between 3 and 10 μl is to be collected ... pooled inside the first clip part 241b through the blood collection hole 241c”, col. 4 lines 7-18 & col. 5 lines 41-65 & col. 10 lines 30-41 & col. 16 lines 19-26 & 52-65), the predetermined amount of the sample being obtained from the sample flowing out of the sample outflow hole when the contact surface is pressed to the surface around the sample outflow hole (“urged to be closed state ... blood is pooled inside the first clip part 241b ... finger is held by the force applied ... blood can be congested in the blood collection site”, col. 16 lines 37-65).
Regarding claim 2, Hirao discloses the sample collection device according to claim 1, wherein the predetermined amount is determined by at least one of a volume of the retaining space, a shape of the retaining space, a material of the sample collection unit, and a chemical property of a wall defining the retaining space (“provide quantitativity ... setting the size ... blood in the range between 3 and 10 μl ... volume”, col. 4 lines 7-18 & col. 16 lines 6-36).
Regarding claim 3, Hirao discloses the sample collection device according to claim 1, further comprising a grip connected to the outer surface (first grip part 241a, figs. 24A-25).
Regarding claim 4, Hirao discloses the sample collection device according to claim 3, wherein the grip is formed of a hard material (“material ... metal”, col. 9 lines 15-20 & col. 16 lines 1-5).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hirao in view of Perez (US 20020188223 A1).
Regarding claim 5, Hirao discloses the sample collection device according to claim 1. Hirao does not expressly disclose wherein a wall defining the retaining space is hydrophilic.
However, Perez directed to the sampling of a bodily fluid obtained from an incision in the skin discloses a retaining space (capillary passageway 24, para. [0068]), wherein a wall defining the retaining space (“capillary tube 17 .... interior wall”, para. [0068]) is hydrophilic (“interior passageway which is formed of a material that is naturally hydrophilic or has been treated to be hydrophilic”, para. [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirao such that a wall defining the retaining space is hydrophilic, in view of the teachings of Perez, as this would aid in drawing the blood upwardly into the passageway/blood collection hole by enhancing the capillary action/phenomenon.
Regarding claim 6, Hirao discloses the sample collection device according to claim 1. Hirao does not expressly disclose wherein at least a part of the contact surface and/or at least a part of the outer surface are/is hydrophobic.
However, Perez directed to the sampling of a bodily fluid obtained from an incision in the skin discloses a contact surface and an outer surface (“end opening of the capillary passageway ... outer surface 25”, para. [0068], figs. 5-7), wherein at least a part of the contact surface and/or at least a part of the outer surface are/is hydrophobic (“capillary tube may further be treated or constructed to have a hydrophobic outer surface 25”, para. [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirao such that at least a part of the contact surface and/or at least a part of the outer surface are/is hydrophobic, in view of the teachings of Perez, as this would aid in inhibiting attraction of the bodily fluid to the exterior of the capillary/blood-collection position indicator.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hirao in view of Chu (US 5558834 A)
Regarding claim 7, Hirao discloses the sample collection device according to claim 1. Hirao does not expressly disclose wherein at least a part of a surface of the grip is hydrophobic.
However, Chu directed to a method and device to efficiently separate and accurately assay small volumes of whole blood including withdrawing a whole blood sample in a "noninvasive" amount (col. 4 lines 19-42 & col. 12 lines 10-26) discloses a grip (handle 12, fig. 1), wherein at least a part of a surface of the grip is hydrophobic (“handle 12 be manufactured from a hydrophobic material”, col. 21 lines 7-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirao such that at least a part of a surface of the grip is hydrophobic, in view of the teachings of Chu, as this would aid in facilitating the quantitative determination by manufacturing the clip of hydrophobic plastic and inhibit attraction of the bodily fluid to the clip.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hirao in view of Ji (US 20230194389 A1).
Regarding claim 8, Hirao discloses the sample collection device according to claim 1. Hirai further discloses that the size of the blood-collection position indicator 20 is not particularly limited, but for example, its overall length is in the range between 30 and 50 mm and its overall width is in the range between 5 and 30 mm (col. 6 lines 6-18).
Hirao does not expressly disclose a sample processing device comprising: a sample processing container used for processing the sample, the sample collection unit having a size suitable to be housed in the sample processing container.
However, Ji directed to devices, kits, systems, and methods for collecting samples for analytical analysis discloses a sample processing device (Abstract) comprising a sample collection device (swab device (200), fig. 1C) and a sample processing container (extraction tube body (110), fig. 1C) used for processing the sample (“sample processing and analysis”, para. [0019, 0083]), the sample collection unit having a size suitable to be housed in the sample processing container (as seen in figs. 1E-H, “inner diameter ... approximately 9 mm”; “top cap (120) is secured ... the entirety of the swab device (200) ... in the interior space of the extraction tube body (110)”, para. [0076, 0079, 0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirao to incorporate the blood position indicator of Hirao into the devices, kits, systems, and methods for collecting samples for analytical analysis of Ji, as this would aid in providing devices, kits, systems, and methods for collecting samples for analytical analysis and would aid in minimizing and/or eliminating the risk of exposure of a user and/or the environment to a pathogen present in the sample (Ji, para. [0095]).
Regarding claim 9, Hirao discloses the sample collection device according to claim 1. Hirai further discloses that the size of the blood-collection position indicator 20 is not particularly limited, but for example, its overall length is in the range between 30 and 50 mm and its overall width is in the range between 5 and 30 mm (col. 6 lines 6-18).
Hirao does not expressly disclose a sample processing device comprising a sample processing container used for processing the sample, a length of the sample collection device being longer than a length of the sample processing container.
However, Ji directed to devices, kits, systems, and methods for collecting samples for analytical analysis discloses a sample processing device (Abstract) comprising sample collection device (swab device (200), fig. 1C) and a sample processing container (extraction tube body (110), fig. 1C) used for processing the sample (“sample processing and analysis”, para. [0019, 0083]), a length of the sample collection device being longer than a length of the sample processing container (“swab ... length that is longer ... extends from the top”, para. [0074, 0076-0077, 0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirao to incorporate the blood position indicator of Hirao into the devices, kits, systems, and methods for collecting samples for analytical analysis of Ji, as this would aid in providing devices, kits, systems, and methods for collecting samples for analytical analysis and enable swirling of the sample collection device to release a portion of the analyte in the sample (Ji, para. [0090]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kumakura (JP 2010048776 A English Translation) directed to Capillary tube, sample collection device, and sample collection apparatus – see figs. 5-6; Cho (US 20200330013 A1) directed to a unit for collecting blood – see fig. 2; Cho (US 20210100487 A1) directed to a unit for collecting and ejecting blood – see fig. 2; Komiyama (JP 2010048776 A English Translation) directed to a sample collection device, and sample collection kit equipped therewith – see fig. 4; Kim (US 20230264185 A1) directed to a capillary blood pipette tip system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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