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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 18 April 2026 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 18 June 2026. Claims 1-6 and 9 are currently pending in the application. Claims 7-8 have been previously canceled. Claims 1-6 and 9 are being examined herein.
Status of Objections and Rejections
The rejection of claims 1, 5-6, and 9 under 35 U.S.C. § 103 in view of Choi et al. (U.S. Pat. Pub. No. 2010/0030110) in view of Matsumoto et. al. (U.S. Pat. Pub. No. 2010/0030037) and further in view of Choi et al. (U.S. Pat. Pub. No. 2017/0128131) are withdrawn in view of arguments and amendments.
The rejection of claims 2-3 under 35 U.S.C. § 103 in view of Choi et al. (US 20100030110 A1) in view of Matsumoto et. al. (US 20100030037 A1) and Choi et al. (US 20170128131 A1) and in further view of Sui, et. al. (US 20190090791 A1 are withdrawn in view of arguments and amendments.
The rejection of claim 4 under 35 U.S.C. § 103 in view of Choi et al. (US 20100030110 A1) in view of Matsumoto et. al. (US 20100030037 A1) and Choi et al. (US 20170128131 A1) and in further view of Cunningham, et. al. (US 20020169393 A1) are withdrawn in view of arguments and amendments.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues against the combination of Choi et al. (US 20100030110 A1) in view of Matsumoto et. al. (US 20100030037 A1) and Choi et al. (US 20170128131 A1), particularly in relation to the amended limitations (Remarks, pg. 4, par. 05 – pg. 7, par. 02).
Examiner presents a rejection for claim 1 below that no longer relies on the above prior art but instead is rejected in view of Choi (KR 20060107187 A; citations made with respect to provided English machine translation and original document) and Gruzdev et. al. (US 20020058953 A1).
Examiner notes the continues use of Matsumoto et. al. (US 20100030037 A1) in the rejection of claim 5 as well as the use of Sui, et. al. (US 20190090791 A1) for the rejection of claims 2-3 and Cunningham, et. al. (US 20020169393 A1) for claim 5 as no argument is presented against the previous rejections of the amended claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "formed on the same connecting structure." in lines 19-20 of the claim. There is insufficient antecedent basis for this limitation in the claim a no connecting structure is previously recited the claim. Examiner recommends amending the claim to recite “formed on a same connecting structure” or an equivalent thereof.
Claims 2-6 and 9 are rejected based on their dependence on claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (KR 20060107187 A; citations made with respect to provided English machine translation and original document) in view of Gruzdev et. al. (US 20020058953 A1).
Regarding claim 1, Choi teaches a blood collection device comprising a blood glucose measurement device and a laser for painless blood collection (Abstract) (a lancing and blood glucose level measuring device). Choi teaches the device comprises an Er:YAG laser system (Fig. 4; pg. 5, par. 06) configured to penetrate the skin to draw blood (pg. 7, par. 01-02). While Choi does not explicitly state a laser oscillation unit, the components of the laser oscillator system such as a gain medium, Er:YAG crystal 6, and an optical resonator, mirror 7 and reflector 23 (Fig. 4; pg. 5, par. 06); therefore, one of ordinary skill in the art will understand the laser system of Choi is a laser oscillator system (a laser oscillation unit that is accommodated within the casing and configured to generate a laser beam for blood sampling).
Choi teaches the second aspect of the device comprises a blood glucose meter; specifically, a connector 12 receives a test strip 24 and blood sugar information is transmitted to blood sugar measuring circuit 13 (blood glucose level measuring unit) (Fig. 4; pg. 9, par. 02) (a blood glucose level measuring unit that is accommodated within the casing and configured to measure a blood glucose level).
While not explicitly disclosed, one of ordinary skill in the art can conclude the above listed parts of the device are enclosed in a housing or casing, see the larger encompassing outline in Figure 4, as well as the fact the device is portable (Abstract) and designed to be a "personal hand-held blood glucose measurement device in which painless blood collection and blood glucose measurement are performed in a single device so that blood glucose can be measured" (pg. 3, par. 06); therefore, one of ordinary skill in the art will understand the blood collection and blood glucose measuring device of Choi comprises a casing wherein the laser oscillation unit and the blood glucose measuring unit are enclosed within said casing.
Choi further teaches adapter 19 (a contact unit) on a side of the casing in line with the laser system comprising focusing lens 8 that focuses the laser in a specific direction of the surface blood is to be collected (Fig. 1, 4; pg. 7, par. 01, 04) and comprising a cap 9 (disposable cap) through adapter 19 configured create an airtight connect between the finger of the user and the device (Fig. 1, 3; pg. 7; par. 06) (a contact unit that is formed on a part of one side of the casing and configured to irradiate the laser beam toward an irradiation target area, wherein the contact unit includes a disposable cap to be in contact with the irradiation target area). Choi additionally teaches cap 9 can be inserted into adapter 19 when pressure is applied by a finger; wherein when sufficient pressure is applied a vacuum is generated by a pressing plate type vacuum control button to improve sample collection (pg. 7, par. 06) (a pressure sensor that directly senses a pressure generated by contact between the irradiation target area and the disposable cap).
Choi teaches the device further comprises a connector 12 (blood glucose strip insertion unit) at a side of the device adjacent to the adapter 19 and cap 9 and is configured to receive a test strip 24 (blood glucose strip) and connected to blood sugar measuring circuit 13 (blood glucose level measuring unit) (Fig. 4; pg. 9, par. 02) (a blood glucose strip insertion unit which is formed on another part of one side of the casing and into which a blood glucose strip including a blood glucose sensor that transmits and receives signals to and from the blood glucose level measuring unit to measure a blood glucose level is to be inserted).
Choi teaches the device and all above mentioned components of the device are electrically connected to and controlled by a printed circuit board (PCB) 16 with a microprocessor (controller) (pg. 5, par. 02-03; pg. 9, par. 04) (a controller configured to control the laser oscillation unit).
Choi teaches adapter 19 (a contact unit) and connector 12 (blood glucose strip insertion unit) are on a shared side of the device (wherein the contact unit and the blood glucose strip insertion unit are formed on the same connecting structure).
While Choi teaches a certain pressure is needed to create a vacuum with a pressing plate type control button upon sample collection, Choi is silent to a pressure sensor that operates by detecting a change in at least one of voltage and current, wherein the pressure sensor includes a pogo pin through which a contact sensing circuit is connected when a predetermined pressure is applied to the disposable cap.
Gruzdev teaches a laser for perforating skin to collect blood samples (Abstract). Gruzdev teaches a device comprising a laser source (pictured in Fig. 1), wherein the laser beam exits the device (to perforate the skin of a user's finger (irradiation target)) through a cup 130 (contact unit) (Fig. 9, par. 0068). The cup 130 further comprises a base 122 with a cavity 126 between engaging segments 124 (cap), wherein the engaging segments comprise a front part 132 for engaging with the skin surface and a rear part 134 configured for slidable movement (Fig. 9; par. 0068). Within inner cavity 126 are contacts 136 configured to be engaged with respective openings 138 wherein the connection between contacts 136 and openings 138 (pressure sensor) must overcome a force requirement generated by biasing member/spring 140 (pogo pin) (Fig. 9;par. 0068). In order to activate the laser source, a sufficient pressure (predetermined pressure) must be applied to engaging segment 124 to overcome biasing member 140 allowing for physical and therefore electrical contact to be made by contacts 136 and openings 138 (par. 0068) (a pressure sensor that directly senses a pressure generated by contact between the irradiation target area and the disposable cap by detecting a change in at least one of voltage and current, wherein the pressure sensor includes a pogo pin through which a contact sensing circuit is connected when a predetermined pressure is applied to the disposable cap). Gruzdev teaches the engaging conductive segments prevents unintentional activation laser perforator (par. 0015, 0068).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the pressure sensor in the contact unit of Choi to be detect a change in at least one of voltage and current, wherein the pressure sensor includes a pogo pin through which a contact sensing circuit is connected when a predetermined pressure is applied to the disposable cap as taught by Gruzdev because the pressure sensor and associated elements prevents accidental discharge of the laser perforation device (Gruzdev, par. 0015, 0068) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 6, modified Choi teaches the device further comprises a microprocessor mounted PCB 16 and program (a communication module) for recording and measuring blood glucose measurement results (Choi, pg. 12, par. 06-07). Wherein the PCB 16 controls output information displayed on an LCD 14 (user device) on the outside casing of the device (Choi, Fig. 4; pg. 9, par. 04) (wherein the casing further includes a communication module that transmits blood glucose level data measured by the blood glucose level measuring unit to a user device connected to the lancing and blood glucose level measuring device).
Regarding claim 9, modified Choi teaches wherein the PCB 16 controls the laser (Choi, pg. 9, par. 04) (the controller operates the laser oscillation unit). Modified Choi in view of Gruzdev teaches in order to activate the laser source, a sufficient pressure (predetermined pressure) must be applied to engaging segment 124 to overcome biasing member 140 allowing for physical and therefore electrical contact to be made by contacts 136 and openings 138 (Gruzdev, par. 0068) (wherein when a pressure value sensed by the pressure sensor is equal to or higher than a predetermined value, the controller operates the laser oscillation unit).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (KR 20060107187 A; citations made with respect to provided English machine translation and original document) and Gruzdev et. al. (US 20020058953 A1) as applied to claim 1 above, and further in view of Sui, et. al. (US 20190090791 A1; previously referenced).
Regarding claim 2, modified Choi teaches the device utilizes blood glucose test strips such as those known in the art (Choi, pg. 2, par. 07). Choi teaches the test strip 24 is inserted in connect 12 located at a side portion of the device (Choi, Fig. 4; pg. 9, par. 02) (wherein the blood glucose strip… [is] exposed at a peripheral portion of the blood glucose sensor).
Modified Choi is silent to wherein the blood glucose strip includes a blood absorbing member formed of a super absorbent polymer to absorb blood remaining.
Sui teaches a sensor for test biological sample (Abstract). Sui teaches the use of a separator (blood absorbing member) made of a superabsorbent polymer (SAP) in tandem with a test pad/strip (par. 0049) (wherein the blood glucose strip includes a blood absorbing member formed of a super absorbent polymer to absorb blood remaining). Sui teaches the superabsorbent polymer controls the amount and flow of liquid on the test strip to ensure accurate readings and prevent any sort of cross-contamination (par. 0049).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the test strip of modified Choi to further include a blood absorbing member from of a super absorbent polymer as taught by Sui because the absorbing member controls liquid flow along the test strip to ensure accurate readings and prevent any sort of cross-contamination (Sui, par. 0049) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 3, modified Choi in view of Sui teaches separator made of a superabsorbent polymer (SAP) that is used with/on the test pad allows for the strip to engage with the sensor when the SAP of the separator is swelled due to liquid (blood) absorption (Sui, par. 0049). In other words, the SAP separator layer 502 swells and allows strip 302 (see Sui, Fig. 5) to seal the strip as a whole within the sealed enclosure 309 against prism 306 (Sui, Fig. 3; par. 0049). Therefore, the SAP separator layer is always spaced apart from the sensor by the height of the strip 302 (wherein the super absorbent polymer is spaced apart from the blood glucose sensor by a predetermined distance).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Choi (KR 20060107187 A; citations made with respect to provided English machine translation and original document) and Gruzdev et. al. (US 20020058953 A1) as applied to claim 1 above, and further in view of Cunningham, et. al. (US 20020169393 A1; previously referenced).
Regarding claim 4, modified Choi teaches the laser is capable of heating the surface of the skin (irradiation target area) (pg. 10, par. 01).
Modified Choi is silent to a heating member that is formed on yet another part of one side of the casing and configured to apply heat around the irradiation target area.
Cunningham teaches a method and apparatus for collecting a blood sample through lancing the skin for diagnostic tests such as glucose monitoring (Abstract). Cunningham teaches the lancing device comprises a heating device (heating member) configured to heat the area of the skin to be pierced (irradiation target area) (par. 0024, 0026). While not explicitly disclosed, one of ordinary skill in the art can conclude the heating element is on a side of the device casing that is in line with the lancing area because the area to be heated is the same as the area to be lanced (par. 0026) (a heating member that is formed on yet another part of one side of the casing and configured to apply heat around the irradiation target area). Cunningham teaches heating the area of skin to be perforated increased blood flow to the area to be perforated (par. 0026, 0066).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the lancing device of modified Choi to further include a heating member that is formed on yet another part of one side of the casing and configured to apply heat around the irradiation target area as taught by Cunningham because a heating member to heat the extraction area allows for increased blood flow and therefore quicker extraction after perforating the skin (Choi, par. 0026, 0066) with reasonable expectation of success. MPEP 2143(I)(G).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Choi (KR 20060107187 A; citations made with respect to provided English machine translation and original document) and Gruzdev et. al. (US 20020058953 A1) as applied to claim 1 above, and further in view of Matsumoto (US 20100030037 A1; previously referenced).
Regarding claim 5, modified Choi teaches the device measures a blood glucose level (pg. 9, par. 02) (wherein the blood glucose level measuring unit… measures at least one of a blood glucose level).
Modified Choi is silent to wherein the blood glucose level measuring unit includes an optical measuring sensor (that measures at least one of a blood glucose level).
Matsumoto teaches a blood inspection device with a sensor unit (Abstract). Matsumoto teaches a device capable of measuring blood glucose levels (par. 0092). Matsumoto teaches an optical reading section 90 with sensor 22 that radiates drops of blood and outputs a detection signal based on reflected light to measure blood sugar levels (par. 0107) (wherein the blood glucose level measuring unit includes an optical measuring sensor that measures at least one of a blood glucose level). Matsumoto teaches this optical measurement sensor and corresponding method allows for unique color matching of blood components reducing false results due to interference (par. 0108).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the blood glucose level measuring unit of modified Chui to be an optical measuring sensor as taught by Matsumoto because the optical measuring sensor and associated method allow for unique color-based analysis based on the blood component, like glucose, to prevent false readings from interfering components (Matsumoto, par. 0108) with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
