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 .
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.
Response to Arguments
The applicant's amendments and arguments/remarks have been fully considered but are moot in view of the new grounds of rejections presented herein. Specifically, the examiner has provided the Cottler reference to teach the limitations presented in the newly amended claims.
Response to Amendment
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.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (US 2017/0367729) in view of Cottler (US 2005/0033197).
Regarding claim 1, Ginggen teaches a blood picker adapted to draw blood from a human for blood detection (Abstract; Paragraph 0011), wherein the blood picker comprises:
at least one needle adapted to be inserted into a blood vessel of the human for blood detection (Paragraph 0075; ‘one or more needles’ within tip);
a storage device in communication with the at least one needle, wherein the storage device is adapted to collect the blood and provided with a drawing tube in communication with an inner space of the storage device (‘reservoir’ and ‘tubing’; Paragraphs 0070 and 0079); and
a fluid transmission control system comprising a fluid transmission device, a driving controller, and a power supply (Paragraph 0070; ‘ pressure generating source (e.g., a vacuum pump, suction source, or high pressure fluid jet), tubing and/or cables to couple various components, device control electronics and actuation mechanisms, activation mechanisms, a power supply (e.g., an alternator and/or battery component), and/or a user interface.’), wherein the fluid transmission device is in communication with one end of the drawing tube for drawing the blood in the inner space of the storage device; and the power supply is provided with a power source for the driving controller to enable the fluid transmission device, so that after the fluid transmission device is enabled, the inner space of the storage device is controlled by the fluid transmission device to generate a pressure difference with respect to an outside environment of the storage device, thereby allowing the blood in the blood vessel to be drawn through the at least one needle and stored in the storage device (Paragraph 0070; ‘ pressure generating source (e.g., a vacuum pump, suction source, or high pressure fluid jet), tubing and/or cables to couple various components, device control electronics and actuation mechanisms, activation mechanisms, a power supply (e.g., an alternator and/or battery component), and/or a user interface.’).
Cottler teaches wherein a non-return valve is configured at the connection part between the fluid transmission control system and the drawing tube to prevent the blood reflowing back to the fluid transmission control system (Paragraph 0042).
It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Cottler to aid in the prevention of the removed fluid from flowing out of the tube towards the vacuum source (Paragraph 0042 of Cottler).
Regarding claim 9, Ginggen teaches wherein the needle, the storage device, and the drawing tube are disposable (Paragraphs 0082 and 0061; examiner notes all components would be capable of being disposed).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (US 2017/0367729) in view of Cottler (US 2005/0033197) in further view of Yoon (US Patent No. 5336176).
Regarding claim 2, Ginggen is silent on the needle with hollow and solid portions. Yoon teaches wherein the needle comprises a hollow soft needle portion (34) and a solid needle portion (32); the solid needle portion is received in the hollow soft needle portion, slightly exposed from the hollow soft needle portion, and adapted to penetrate the blood vessel of the human (Column 6, Lines 4-9; Figure 1), so that the hollow soft needle portion is allowed to be inserted into the blood vessel (Column 1, Lines 25-28; exemplary Figures 7-11)); after the solid needle portion is removed from the hollow soft needle portion, the hollow soft needle portion is adapted to be connected to the storage device (chamber 94). It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Yoon because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the needles of Ginggen with those of Yoon.
Regarding claim 3, Ginggen is silent on wherein a length of the hollow soft needle portion is in a range between 1000 pm and 2000 pm, and a hole diameter of the hollow soft needle portion is in a range between 10 pm and 1000 pm. The applicant' s specification provides no specifical reasoning or critical functionality for the use of a length of the hollow soft needle portion is in a range between 1000 pm and 2000 pm, and a hole diameter of the hollow soft needle portion is in a range between 10 pm and 1000 pm, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the length of the hollow soft needle portion in a range between 1000 pm and 2000 pm, and the hole diameter of the hollow soft needle portion in a range between 10 pm and 1000 pm as desired by the user as a matter of routine engineering design choice.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (US 2017/0367729) in view of Cottler (US 2005/0033197) and in further view of Bernstein et al. (US 2011/0105951).
Regarding claim 4, Ginggen is silent on the needle being a microneedle. Bernstein teaches wherein the needle is a microneedle (‘one or more needles, microneedles’; Paragraph 0099). It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Bernstein because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the needles of Ginggen with the microneedles of Bernstein which Bernstein teaches as being alternatives to each other (Paragraph 0099 of Bernstein).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (US 2017/0367729) in view of Cottler (US 2005/0033197) and in further view of Yoon (US Patent No. 5336176) and Zadini et al. (US Patent No. 5312361).
Regarding claim 7, Ginggen is silent on the blood detector being outside the storage device. Zadini teaches wherein a blood detector is disposed outside the storage device (Figure 53; detector 950/952, storage device 928), and Yoon teaches the blood detector (ball 100) is adapted to detect whether blood exists in the storage device so as to determine whether the needle is correctly inserted into the blood vessel (Column 8, Lines 32-36). It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Zadini and Yoon because it serves as an indicator of correct blood draw (Column 8, Lines 32-36 of Yoon) and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 VI-C).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (US 2017/0367729) in view of Cottler (US 2005/0033197) and in further view of Flaherty (US 2005/0027233).
Regarding claim 8, Ginggen is silent on the connection portion. Flaherty teaches wherein a connection portion (21) is provided between the storage device (20 and 26) and the drawing tube (19), and the connection portion is adapted to allow the storage device and the drawing tube to be assembled with or detached from each other (Paragraph 0026). It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Flaherty in order to each disposal of the different parts of the device (Paragraph 0026 of Flaherty).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginggen et al. (US 2017/0367729) in view of Cottler (US 2005/0033197) and in further view of Mou et al. (US 2019/0133455).
Regarding claim 10, Ginggen is silent on the fluid transmission device with a gas pump.
Mou teaches wherein the fluid transmission device of the fluid transmission control system is a gas pump (Paragraphs 0026-0027), and the gas pump comprises:
An inlet plate (221) having at least one inlet hole (221 a), at least one convergence channel (221 b), and a convergence chamber (221 c), wherein the at least one inlet hole is used to introduce the gas into the gas pump (Paragraph 0026), the at least one inlet hole correspondingly penetrates into the at least one convergence channel, and the at least one convergence channel is converged at the convergence chamber, so that the gas introduced from the at least one inlet hole is converged at the convergence chamber (Paragraph 0026; “Moreover, as shown in FIGS. 5 and 6, the gas inlet plate 221 has at least one inlet aperture 221 a, at least one convergence channel 221 b and a convergence chamber 221 c. The at least one inlet aperture 221 a allows gas to flow in. The convergence channel 221 b is disposed correspondingly to the inlet aperture 221 a and guides the gas from the inlet aperture 221 a toward the convergence chamber 221 c.“);
a resonance sheet (222) attached to the inlet plate (Paragraphs 0026-0027), wherein the resonance sheet (222) has a perforation (222a), a movable portion (222b), and a fixed portion (Figures 4-6), wherein the perforation is located at a center portion of the resonance sheet (Figures 4-6) and is corresponding to the convergence chamber of the inlet plate, the movable portion is disposed surrounding the perforation that is corresponding to the convergence chamber, and the fixed portion is disposed at an outer periphery of the resonance sheet and is attached to the inlet plate (Figures 4-6; Paragraph 0026; “The resonance plate 222 has a central aperture 222 a corresponding in position to the convergence chamber 221 c. The resonance plate 222 further includes a movable part 222 b surrounding the central aperture 222 a. The piezoelectric actuator 223 and the resonance plate 222 are disposed facing each other. A gap is formed between the resonance plate 222 and the piezoelectric ceramic plate 223 b of the piezoelectric actuator 223, so that when the piezoelectric actuator 223 is driven, the gas is inhaled through at least one inlet aperture 221 a of the gas inlet plate 221, converged to the convergence chamber 221 c along the convergence channel 221 b and transported into the gap through the central aperture 222 a of the resonance plate 222. Whereby, the gas is further transported through a resonance between the piezoelectric ceramic plate 223 b of the piezoelectric actuator 223 and the movable part 222 b of the resonance plate 222.”); and
a piezoelectric actuator attached and disposed in corresponding to the resonance sheet (Paragraphs 0026-0027), wherein the piezoelectric actuator comprises a suspension plate (223 a), an outer frame, at least one supporting element, and a piezoelectric element; the suspension plate is capable of bending and vibrating; the outer frame is disposed around a periphery of the suspension plate; the at least one supporting element is formed between the suspension plate and the outer frame to provide a flexible support for the suspension plate; the piezoelectric element is attached to a surface of the suspension plate so as to drive the suspension plate to bend and vibrate when the piezoelectric element is applied with a voltage (Paragraphs 0026 and 0027),
wherein a chamber space is formed between the resonance sheet and the piezoelectric actuator, so that when the piezoelectric actuator is driven by the voltage, the gas outside the gas pump is introduced into the gas pump through the at least one inlet hole of the inlet plate, is converged at the convergence chamber through the at least one convergence channel, flows through the perforation of the resonance sheet, and is transmitted by a resonance effect resulting between the piezoelectric actuator and the resonance sheet (Paragraphs 0026-0027).
It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Mou because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the fluid transmission device of Ginggen with that of Mou.
Regarding claim 11, Ginggen is silent on the fluid transmission device with a gas pump. Mou teaches wherein the gas pump further comprises a first insulation sheet (2241), a conductive sheet (225), and a second insulation sheet (2242); and the inlet plate (221), the resonance sheet (222), the piezoelectric actuator (223), the first insulation sheet, the conductive sheet, and the second insulation sheet are sequentially stacked with each other (Paragraph 0026).
It would have been obvious to one of ordinary skill in the art to have modified Ginggen with Mou because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the fluid transmission device of Ginggen with that of Mou.
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 PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791