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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/25 has been entered.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ivosevic (US 20190216380 A1).
For claim(s) 14, Ivosevic teaches A blood sample guiding instrument [100] used in a blood test kit, the blood sample guiding instrument comprising:
a cylindrical body [12] in which a first opening [opening of 12 nearest 30 and 26] , which is configured on a first side of the cylindrical body, [Fig(s). 22-31]
and a second opening, [opening of 12 opposite 30 and 26] which is configured on a second side of the cylindrical body, the second side of the cylindrical body opposite to the first side of the cylindrical body, communicating with the first opening are defined and which comes into contact with a finger;
and a clamping portion [36] that is attached to an outer circumferential surface of the cylindrical body, clamps a finger, and presses the cylindrical body against the finger, [Fig(s). 22-31]
wherein the clamping portion includes a support member, [20] and at least two binding members [38] that are disposed to be spaced from each other,
the support member is configured to support a palm side of the finger, and extends from one side of the outer circumferential surface of the cylindrical body in a direction away from a center axis of the cylindrical body, [Fig(s). 22-31]
each of the at least two binding members is configured to bind the finger from one side surface of the finger to another side surface of the finger via a back of the finger, and is positioned on and extends from a third side [side nearest / including 38] of the outer circumferential surface of the cylindrical body in the direction away from the center axis of the cylindrical body, [38 extending away from central axis of 20]
the third side of the cylindrical body configured between the first side of the cylindrical body and the second side of the cylindrical body, [e.g., 38 between any two opposing sides of 20]
and in a state where the finger is bound by the at least two binding members, the outer circumferential surface of the cylindrical body comes into contact with the one side surface of the finger. [Fig(s). 22-31]
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.
Claim(s) 1, 4-5, and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Sei (US 20110118568 A1).
For claim 1, Ivosevic teaches A blood sample guiding instrument used in a blood test kit, the blood sample guiding instrument comprising:
a cylindrical body [12] in which a first opening and a second opening communicating with the first opening are defined and which comes into contact with a finger; [Figs. 2-3, Figs. 22-31]
and a clamping portion [36] that is attached to an outer circumferential surface of the cylindrical body, clamps a finger, and presses the cylindrical body against the finger, [Figs. 2-3, Figs. 22-31]
wherein the clamping portion includes a support member, [20] and at least two binding members [38] that are disposed to be spaced from each other,
the support member is configured to support a palm side of the finger, and extends from one side of the outer circumferential surface of the cylindrical body in a direction away from a center axis of the cylindrical body, [Figs. 2-3, Figs. 22-31]
each of the at least two binding members is configured to bind the finger from one side surface of the finger to another side surface of the finger via a back of the finger, and extends from the one side of the outer circumferential surface of the cylindrical body in the direction away from the center axis of the cylindrical body, [Figs. 2-3, Figs. 22-31]
in a state where the finger is bound by the at least two binding members, the outer circumferential surface of the cylindrical body comes into contact with the one side surface of the finger. [Figs. 2-3, Figs. 22-31]
For claim(s) 1, Ivosevic fails to teach cut-out portions and a complimentary bar-shaped member.
Sei teaches a blood sample guiding instrument [abstract] comprising a finger holder [36] forming a cut-out portion [88a17076228] and a bar-shaped member [86a] on a distal end side [Fig(s). 1-2] of binding members [86, 88] which is configured to fit into the cut-out portion such that the holder surrounds the entire finger [F] while in use. [Fig(s). 1]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the device of Ivosevic to incorporate the bar-shaped member and cut-out portions of Sei in order to ensure the device is securely attached to the finger during use. As motivated by Sei ¶8.
For claim 2, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein the first opening of the cylindrical body is larger than the second opening, and at least a part of an inner circumferential surface of the cylindrical body forms a tapered surface. [any one or more of openings as in Figs. 6-7 and Fig. 12]
For claim 4, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein the binding member adjusts a clamping force for the finger. [¶¶65-67]
For claim 5, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein the binding member is provided at a positioning portion provided on the outer circumferential surface of the cylindrical body. [Figs. 1-7]
For claim 10, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein a shape of a part of the cylindrical body which comes into contact with the finger is a curved shape protruding toward a finger side in a top view. [Figs. 2-3, Figs. 22-31]
For claim 11, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein each of the at least two binding members has a thinned portion which is formed by partially thinning a thickness of each of the at least two binding members, and each of the at least two binding members is configured to be deformable starting from the thinned portion. [Figs. 1-7, ¶¶65-67]
For claim 12, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein the support member has a fitting part [40] configured to detachably fit with each of the at least two binding members, on an end part of the support member.
For claim(s) 13, Ivosevic teaches The blood sample guiding instrument according to claim 1,
wherein the clamping portion is configured to clamp the finger where the finger is punctured from a side, when the blood sample guiding instrument is in use. [Figs. 2-3, Figs. 22-31]
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Sei and Ikegami (US 6050956 A).
For claim(s) 6, Ivosevic fails to teach the cylindrical body having water repellency.
Ikegami teaches a blood sampling device with a water repellent cylindrical body. [col. 3 ll. 10-30]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the cylindrical body of Ivosevic to incorporate the water repellency of Ikegami in order to reduce the chance of blood sticking to a surface other than the collection container. As motivated by Ikegami col. 3 ll. 10-30.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Sei and DeVaughn (US 5662127 A).
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims.
For claim(s) 7-8, Ivosevic teaches The blood sample guiding instrument according to claim 1, further comprising, on a second opening side of the cylindrical body, a connecting portion [26] that is connected to an opening of a storing instrument. [16]
For claim(s) 7-8, Ivosevic fails to teach the storing instrument storing a diluent solution. However, Ivosevic does generally suggest ensuring sample sterility in ¶85 and ¶107.
DeVaughn teaches a blood sample storing instrument [29] which stores a diluent solution [col. 10 ll. 10-20].
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the blood collector (storing instrument) of Ivosevic to incorporate the diluent solution (i.e., buffer, pH indicator, enzyme inhibitor) of DeVaughn (i.e., to add the solution of DeVaughn into the storage tube of Ivosevic) in order to aid in blood sample testing and reduce potential contamination of the blood sample. As motivated by Ivosevic ¶85, ¶87, Devaughn col. 10 ll. 10-20.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Sei, DeVaughn and Olson (US 20180353952 A1).
For claim(s) 9, Ivosevic in view of DeVaughn is silent regarding a separating instrument that separates the blood plasma.
Olson teaches that many blood tests require plasma to be separated out of a blood sample and that such an effect can be achieved by centrifugation or filtration. [¶3]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the testing kit of Ivosevic and DeVaughn to incorporate a centrifuge or filter as taught by Olson in order to aid in separating out blood plasma for testing of a blood specimen. As motivated by Olson ¶3.
Response to Arguments
Applicant’s arguments with respect to the prior art have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791