DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on April 15, 2026 were received and fully considered. Claims 1, 8, and 10 were amended. Claims 15-20 are new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 1, 2, 8, 9, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hiroshi et al. (JP2019088391) (hereinafter “Hiroshi”).
Hiroshi was applied in the previous office action1.
With respect to claims 1 and 8, Hiroshi teaches a blood collection system and method used for collecting blood of a subject (par.0021 “blood collection device 1… blood collection tube 114”; see also Fig. 1), the blood collection system comprising: a puncturing and blood collection mechanism configured to puncture a finger of the subject with a puncture needle (par.0021 “blood collection tube 114”; par.0036 “puncture needle… pressed against a finger… punctures the skin and capillaries of the finger”); a cuff configured to be attached to the finger of the subject in a rolling manner (par.0021 “cuff 151 that tightens the periphery of a finger 156”); and a cuff control unit configured to supply pressurized air to the cuff so as to inflate the cuff and apply a predetermined pressure to the finger of the subject (par.0023 “pump 154 for controlling the internal pressure of the cuff 151… the tightening pressure of the finger 156 can be adjusted”; par.0053 “predetermined pressure threshold”).
Although Hiroshi does not explicitly teach a cuff that is a balloon body having a band shape, further modification to incorporate this feature would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, finger cuffs with a balloon body having a band shape are widely known in the art. See prior art cited at the end of the current office action for example teaching. Moreover, the cuff with balloon body formed in a band shape depicted in the instant application (see cuff 20 in Fig. 1, and [0037]) appears similar to Hiroshi’s cuff 151 (see below). As both finger cuff assemblies operate with a pump so as to achieve the same purpose (applying pressure to a subject’s finger via increasing/decreasing internal pressure so as to inflate/deflate the cuff), further modifying Hiroshi’s finger cuff 151 to have a balloon body having a band shape would be obvious to PHOSITA as a simple substitution.
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With respect to claims 2 and 9, Hiroshi teaches wherein the cuff control unit supplies the pressurized air to the cuff in a predetermined pattern such that an internal pressure of the cuff repeatedly increases and decreases (par.0052-53, 61).
With respect to claim 19, Hiroshi does not explicitly teach wherein the cuff control unit applies a control voltage having a rectangular waveform to a pump so as to repeat pressurization and depressurization for the finger of the subject, thereby providing the finger with a same effect as that when a person massages the finger. However, further modification of Hiroshi to incorporate this feature would have been obvious to PHOSITA when the invention was filed for the following reasons. First, applying a control voltage having a rectangular waveform is understood to occur (e.g. when operating Hiroshi’s pump ON/OFF). Examiner also cites prior art references at the end of the current office action, which further set forth the known concept of utilizing a rectangular waveform in a blood pressure cuff assembly. Moreover, repeating pressurization/depressurization for the finger would be obvious to the skilled artisan as it is generally known in the art to repeat medical tests, as desired.
Claims 3-7 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hiroshi, de Roode et al. (US PG Pub. No. 2011/0313294 A1) (hereinafter “de Roode”), and Hsiu-Chen et al. (US PG Pub. No. 2005/0257795 A1) (hereinafter “Hsiu-Chen”).
Regarding claims 3 and 10, Hiroshi discloses a light source configured to irradiate the finger of the subject with light (par.0024, 0026, 0028, 0047); a camera configured to image the light that passes through the finger of the subject (par.0024, 0082).
However, Hiroshi does not explicitly teach a blood collection control unit configured to determine a puncture position for the puncture needle by the puncturing and blood collection mechanism based on a captured video from the camera, wherein the blood collection control unit determines the puncture position by detecting positions on a puncture needle trajectory that intersects with shadows of finger veins of the subject in the captured video for the camera so as to puncture a finger vein of the subject with the puncture needle.
de Roode teaches detecting positions on a puncture needle trajectory in the captured video for the camera so as to puncture a finger vein of the subject with the puncture needle (abstract “determining the position of a vein or artery in a member of a living being… IR light emerging from the member is scanned with a camera and the image is produced on a display adjacent to the camera… used to execute the related treatment to the vein or artery”).
Hsiu-Chen teaches utilizing a light source to locate veins appearing as a shadow under the lateral scattering and illumination effect (abstract “superficial veins capable of absorbing red light spectrum easily and appearing as a located blood vessel shadow under the lateral scattering and illumination effect”; par.0026, 0050-67).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hiroshi’s camera such that the needle is positioned in relation to shadows of finger veins as a result of irradiating the finger of the subject for the purpose of determining proper position of a vein or artery, and thereby allowing for appropriate injection positioning, as suggested by de Roode and Hsiu-Chen. Furthermore, Hiroshi expressly teaches utilizing an imaging unit, camera or a CMOS (par.0024, 0082); assessing positional relationship between a finger and puncturing device (par.0022, 0052, 0057-58, 0074-75); and confirming/checking appropriate finger placement in relation to the blood collection device (par.0037-39, 0047-48). Therefore, PHOSITA would have had predictable success modifying Hiroshi when the invention was filed to determine a puncture position based on images/video from the camera in the manner recited for the purpose of optimizing blood collection conditions in accordance with the physical characteristics and the like for the target person, as evidence by Hiroshi (par.0039). For purposes of compact prosecution, Examiner cites additional references that further establish it is known to determine puncture position, using an imaging device, etc. Please see prior art cited at the end of the current office action for additional example teachings.
Regarding claims 4 and 11, Hiroshi suggests wherein the blood collection control unit determines, as a current puncture position, at least a position different from a previous position on the finger of the subject (par.0049-50).
Regarding claims 5 and 12, Hiroshi suggests wherein the light source irradiates the finger of the subject with near-infrared light as the light (par.0024-28, 0047, 0051, 0059, 0083). Although Hiroshi does not explicitly teach the camera is an infrared night vision camera, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed as a simple substitution. Examiner takes official notice that infrared night vision cameras are widely known, i.e. replacing Hiroshi’s camera (par.0024, 0082) with a well-known night vision camera would merely involve routine skill in the art.
Regarding claims 6 and 13, Hiroshi suggests wherein the blood collection control unit authenticates the subject using the finger vein of the subject imaged by the camera (par.0037-39, 0047-50).
Regarding claims 7 and 14, Hiroshi suggests wherein the blood collection control unit authenticates the subject and determines the puncture position using the finger vein on a fingertip end side with respect to a first joint of the finger of the subject (par.0022, 0047-52, 0057-58, 0074-75).
With respect to claim 16, Hiroshi teaches a finger rest disposed above the puncturing and blood collection mechanism, the finger rest having an opening at a position facing a finger pad portion of the finger of the subject placed on the finger rest, wherein the finger pad portion is exposed through the opening (finger rest lid 101 is above puncturing device 112, as depicted in Figs. 3-4).
With respect to claim 17, de Roode teaches a light source configured to irradiate the finger of the subject with light; and a camera configured to image the light that passes through the finger of the subject, wherein the camera images the light that passes through the finger to capture a fingertip image (abstract “determining the position of a vein or artery in a member of a living being… IR light emerging from the member is scanned with a camera and the image is produced on a display adjacent to the camera… used to execute the related treatment to the vein or artery”); and Hsiu-Chen teaches utilizing shadows of [[finger]] veins of the subject (abstract “superficial veins capable of absorbing red light spectrum easily and appearing as a located blood vessel shadow under the lateral scattering and illumination effect”; par.0026, 0050-67). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hiroshi’s camera such that the needle is positioned in relation to shadows of finger veins as a result of irradiating the finger of the subject for the purpose of determining proper position of a vein or artery, and thereby allowing for appropriate injection positioning, as suggested by de Roode and Hsiu-Chen.
With respect to claim 20, Hiroshi does not explicitly teach a blood collection control unit configured to store puncture needle trajectory coordinate data representing coordinates at positions on a puncture needle trajectory, and to determine a puncture position for the puncture needle based on the puncture needle trajectory coordinate data. However, Hiroshi discloses the importance of assessing positional relationship between a finger and puncturing device (par.0022, 0052, 0057-58, 0074-75); and confirming/checking appropriate finger placement in relation to the blood collection device (par.0037-39, 0047-48). Therefore, PHOSITA would have had predictable success modifying Hiroshi when the invention was filed to store puncture needle trajectory coordinate data in the manner recited for the purpose of optimizing blood collection conditions for future collection and in accordance with the physical characteristics and the like for the target person, as evidence by Hiroshi (par.0039).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hiroshi in view of Otsubo et al. (US PG Pub. No. 2018/0220944 A1) (hereinafter “Otsubo”).
With respect to claim 15, Hiroshi teaches a blood collection system, as established above.
However, Hiroshi does not explicitly teach the limitations further recited in claim 15.
Otsubo teaches wherein the puncturing and blood collection mechanism includes a rotary table provided with a plurality of holders each formed of a cylindrical recess, and a lancet is set by being inserted into the holder of the rotary table (see Figs. 8A-8B; par.0071-73 “blood collecting device 800 includes a disk 501, a negative pressure device 503, a holder supporting body 5011 for supporting the disk… The disk 501 includes an individually rotatable upper disk 504 and a lower disk 505. The upper disk includes at least one puncture hole 102 for pressing a puncture target finger… upper disk 504 has at least one puncture hole 102”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hiroshi to incorporate a rotary table provided with a plurality of holders each formed of a cylindrical recess, and a lancet is set by being inserted into the holder of the rotary table, for the purpose of enabling various positions of the puncture needles, as desired (see par.0071-73; Figs. 8A-8B). Examiner also cites additional references that further demonstrate the known nature of utilizing rotary table provided with a plurality of holders. See art cited at the end of the current office action for further example teachings.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hiroshi in view of Callahan et al. (US Patent No. 5094244) (hereinafter “Callahan”).
With respect to claim 18, Hiroshi teaches wherein the cuff control unit includes a pump, a check valve, and a pressure adjustment valve (par.0023).
However, Hiroshi does not teach an air buffer configured to reduce pain of the subject due to rapid pressure changes in the cuff.
Callahan teaches an air buffer configured to reduce pain of the subject due to rapid pressure changes in the cuff (col. 7, lines 13+ “The buffer tank 13 is provided to reduce turbulence and slow the flow rate to the distal cuff 6a, proximal cuff 6b, distal lifter bladder 14a and the proximal lifter bladder 14b”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hiroshi to incorporate an air buffer in order to reduce turbulence and slow the flow rate to the finger cuff (reduce pain of the subject due to rapid pressure changes in the cuff), as evidence by Callahan (col. 7, lines 13+).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NEWLY CITED:
US PG Pub. No. 2005/0148885 A1 (see Fig. 1; par.0095, 0104-0105, 0108, 0114)
US PG Pub. No. 2012/0116250 A1 (see par.0032; Fig. 1)
US PG Pub. No. 2011/0077554 A1 (see par.0146)
US PG Pub. No. 2015/0038858 A1 (see par.0158)
PREVIOUSLY CITED:
US Patent No. 5029583
US PG Pub. No. 2009/0275860
US PG Pub. No. 2011/0015544
Response to Arguments
Applicant's arguments filed with respect to the prior art rejections raised in the previous office action have been fully considered, but are moot in view of the current obviousness rejections that were necessitated by amendment. While the previous anticipation rejections are withdrawn, Examiner applies new obviousness rejections via Hiroshi (claims 1, 2, 8, 9, and 19), de Roode and Hsiu-Chen (claims 3-7 and 10-14), Otsubo (claim 15), and Callahan (claim 18). Therefore, applicant’s arguments are moot in view of the current obviousness rejections. Please see prior art section above for more detail, updated citations, and updated obviousness rationales.
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 Prior Art Citations are based on English Translation of Hiroshi, attached in file wrapper on February 6, 2026.
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