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 .
Status of Claims
In the amendments filed December 5, 2025, claims 1 and 9 were amended, and claims 7-8 were cancelled. Claims 1-6 and 9 are pending for examination and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 10, 2026, was filed after the mailing date of the Non-Final Office Action on August 7, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed December 5, 2025, have been fully considered but they are not persuasive.
First, Applicant argued that the cited references fail to teach the contact unit and the blood glucose strip insertion unit formed on the same connecting structure as recited in amended claim 1. However, it is noted that the combination of separate parts into a single, integral piece is merely a matter of obvious engineering choice. See MPEP 2144.01(V)(B) regarding making integral; see also In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (a claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”).
Second, Applicant argued that the cited references fail to teach a pressure sensor that directly senses a pressure generated between the irradiation target area and the disposable cap as recited in amended claim 1. Choi ‘131 teaches a pressure sensor that directly senses a pressure generated between the irradiation target area and the disposable cap as discussed below (slid sensor is a pressure sensor configured to directly sense a backward slide of a mounting plate on which the spacer barrel and the beam barrel are mounted whereby laser resonator 100 generates a laser beam if the pressure measured by the pressure sensor is equal to or higher than a predetermined pressure; ¶¶ [0089]-[0090]; Fig. 4). Applicant further noted that the direct sensing in amended claim 1 is sensed via a change in voltage or current, whereas Choi ‘131 teaches sensing through mechanical displacement. It is noted that the feature upon which applicant relies (i.e., direct sensing via a change in voltage or current) is not recited in amended claim 1. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 5-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (U.S. Pat. Pub. No. 2010/0030110; hereinafter “Choi”) in view of Matsumoto et al. (U.S. Pat. Pub. No. 2010/0030037; hereinafter “Matsumoto”), and further in view of Choi et al. (U.S. Pat. Pub. No. 2017/0128131; hereinafter “Choi ‘131”).
Regarding claim 1, Choi teaches a lancing and blood glucose level measuring device (lancing and blood glucose measuring in a single equipment; ¶¶ [0003], [0014], and [0075]; Fig. 8), comprising:
a casing (case 32; ¶¶ [0016] and [0058]-[0059]; Fig. 5);
a laser unit (Er:YAG laser beam-generating section; ¶¶ [0075] and [0080]; Figs. 1 and 8) that is accommodated within the casing (see ¶¶ [0016] and [0058]-[0059]; Fig. 6) and configured to generate a laser beam for blood sampling (see ¶¶ [0016], [0093]-[0095], and [0112]);
a blood glucose level measuring unit (blood glucose measuring circuit 23; ¶¶ [0075] and [0111]; Fig. 8) configured to measure a blood glucose level (see ¶¶ [0075] and [0111]-[0114]);
a contact unit (collectively interpreted as skin adhesion cap 13, connection device 14, and the interlock sensor; ¶¶ [0059], [0061], [0079], [0100], and [0104]; Figs. 1-4 and 8) that is formed on a part of one side of the casing (skin adhesion cap 13, connection device 14, and the interlock sensor, which is installed at connection device 14, are collectively attached, i.e., formed, on a front side of case 32; ¶¶ [0059], [0061], [0100], and [0104]; Figs. 2-3 and 8) and configured to irradiate the laser beam toward an irradiation target area (wherein the interlock sensor is operated to radiate the laser beam when the finger is pressed on the skin adhesion cap 13 and the irradiated target area is an area of skin on the finger; ¶¶ [0093] and [0104]), wherein the contact unit includes a disposable cap to be in contact with the irradiation target area (wherein skin adhesion cap 13 is disposable and is to be in contact with an area of skin on the finger, which is interpreted as the irradiation target area; ¶¶ [0059], [0061], and [0073]);
a blood glucose strip insertion unit (connector 25 is a construction element to insert a blood glucose sensor strip 24 and is therefore interpreted as the blood glucose strip insertion unit; ¶ [0111]; Fig. 8) into which a blood glucose strip (blood glucose sensor strip 24; ¶ [0111]; Fig. 8) 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 (wherein blood glucose sensor strip 24 includes a strip surface, which is interpreted as the blood glucose sensor, on which electrical chemical reactions take place to provide blood glucose information and the blood glucose information is transferred to blood glucose measuring circuit 23; ¶¶ [0111]-[0112]; Fig. 8) is to be inserted (see ¶ [0111]); and
a controller (laser beam control circuit 28; ¶¶ [0077] and [0109]-[0110]; Fig. 8) configured to control the laser unit (wherein laser beam control circuit 28 controls the Er:YAG laser beam; [0077] and [0109]-[0110]).
However, Choi does not explicitly teach that the laser unit is a laser oscillation unit and that the controller is configured to control the laser oscillation unit. Matsumoto, in the analogous art of blood test devices, teaches a blood test apparatus (blood test apparatus 11; ¶ [0038]; Fig. 3) comprising a laser oscillation unit (laser emitting apparatus 16 comprising an oscillating tube 16a accommodates Er:YAG laser crystal 16c; ¶ [0040]; Fig. 3) accommodated within the casing (laser emitting apparatus 16 is disposed in housing 12; ¶ [0040]; Fig. 3) and configured to generate a laser beam for blood sampling (see ¶ [0043]). Matsumoto further teaches a controller configured to control the laser oscillation unit (controlling section 66; ¶ [0089]).
Accordingly, the prior art references teach that it is known that Er:YAG laser beam units with and without oscillating units and their associated controllers are functional equivalents for producing a laser beam for blood sampling. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the laser unit and controller as taught by Choi with the laser oscillation unit and controller as taught by Matsumoto because both Er:YAG laser beam units with and without explicit oscillating units and their associated controllers were known equivalents for producing a laser beam for blood sampling. See MPEP 2143(I)(B) regarding simple substitution of one known element for another to obtain predictable results. The substitution would have resulted in the predictable result of producing a laser beam for blood sampling.
In addition, while Choi teaches a blood glucose level measuring unit, a blood glucose strip insertion unit, and a laser unit in a single equipment (see ¶ [0075]), Choi does not explicitly teach wherein the blood glucose level measuring unit is formed within the casing, and the blood glucose strip insertion unit is formed on another part of one side of the casing.
Matsumoto, in the analogous art of blood test devices, teaches a blood test apparatus (blood test apparatus 11; ¶ [0038]; Fig. 3) wherein the laser oscillation unit (laser emitting apparatus 16; ¶ [0040]; Fig. 3) is accommodated within the casing (laser emitting apparatus 16 is disposed in housing 12; ¶ [0040]; Fig. 3), the blood glucose level measuring unit (electrical circuit section 18 measures blood sugar level from blood; ¶ [0041]; Fig. 3) is formed within the casing (electrical circuit section 18 is within housing 12; Fig. 3), and the blood glucose strip insertion unit (opening part 12a is an opening that is capable of receiving a blood glucose strip and therefore it is interpreted as the blood glucose strip insertion unit; ¶ [0038]; Fig. 3) (Examiner’s Note — a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; see Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a device does”); see also MPEP 2114(II)) is formed on another part of one side of the casing (opening part 12a is formed on another part of housing 12; Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Choi to position the blood glucose level measuring unit within the casing, and the blood glucose strip insertion unit on another part of one side of the casing as taught by Matsumoto for the benefit of protecting the components of the blood test apparatus from the external environment.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Choi to position the blood glucose level measuring unit within the casing, and the blood glucose strip insertion unit on another part of one side of the casing because such modification merely involves a rearrangement of parts that would not have modified the operation of the device. See MPEP 2144.04(VI)(C) regarding rearrangement of parts; see also In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
However, Choi in view of Matsumoto does not explicitly teach wherein the contact unit further includes a pressure sensor that directly senses a pressure generated by contact between the irradiation target area and the disposable cap. Choi ‘131, in the analogous art of laser irradiating apparatus for collecting blood, teaches a laser apparatus (multi-function laser irradiating apparatus 10; ¶ [0080]) comprising a pressure sensor that directly senses a pressure generated by contact between the irradiation target area and a front end of the laser apparatus wherein when a pressure value sensed by the pressure sensor is equal to or higher than a predetermined value, the controller operates the laser unit (slid sensor is a pressure sensor configured to directly sense a backward slide of a mounting plate on which the spacer barrel and the beam barrel are mounted whereby laser resonator 100 generates a laser beam if the pressure measured by the pressure sensor is equal to or higher than a predetermined pressure; ¶¶ [0089]-[0090]; Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact unit of Choi in view of Matsumoto to incorporate a pressure sensor as taught by Choi ‘131, such that the controller (of Choi in view of Matsumoto) operates the laser oscillation unit (of Choi in view of Matsumoto) when a pressure value sensed by the pressure sensor is equal to or higher than a predetermined value, for the benefit of providing a safety measure when operating the device (Choi ‘131, ¶ [0083]).
The combination of Choi, Matsumoto, and Choi ‘131 does not explicitly teach wherein the contact unit and the blood glucose strip insertion unit are formed on the same connecting structure. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Choi, Matsumoto, and Choi ‘131 wherein the contact unit and the blood glucose strip insertion unit are formed on the same connecting structure because the combination of separate parts into a single, integral piece is merely a matter of obvious engineering choice. See MPEP 2144.01(V)(B) regarding making integral; see also In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (a claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”).
Regarding claim 5, the combination of Choi, Matsumoto, and Choi ‘131 teaches the lancing and blood glucose level measuring device of claim 1 as discussed above. Choi does not explicitly teach wherein the blood glucose level measuring unit includes an optical measuring sensor that measures at least one of a blood glucose level, a blood pressure and a blood oxygen level. However, Matsumoto teaches a blood test apparatus (blood test apparatus 11-2; ¶ [0107]; Fig. 19) comprising an optical measuring sensor (optical reading section 90; ¶ [0107]; Fig. 19) that measures at least one of a blood glucose level, a blood pressure and a blood oxygen level (wherein optical reading section 90 detects the state of a sensor and optically reads blood taken in sensor to measure the blood sugar level based on a detection signal; ¶ [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the blood glucose level measuring unit (of Choi, Matsumoto, and Choi ‘131) to incorporate an optical measuring sensor as taught by Matsumoto for the benefit of using custom-designed reagent to a sensor such that the sensor shows a unique color matching a blood component to be measured and therefore optical measurements are tailored to the grade of color of that specific blood component (see Matsumoto, ¶ [0108]).
Regarding claim 6, the combination of Choi, Matsumoto, and Choi ‘131 teaches the lancing and blood glucose level measuring device of claim 1 as discussed above. Choi does not explicitly teach 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. However, Matsumoto teaches a lancing and blood glucose level measuring device (blood test apparatus 11-2; ¶ [0107]; Fig. 19) comprising a casing (housing 12; ¶ [0107]; Fig. 19) that includes a communication module (communication section 67 which is part of electrical circuit section 18-2 within housing 12; ¶¶ [0109]-[0110]; Figs. 19-20) that transmits blood glucose level data measured by a blood glucose level measuring unit to a user device connected to the lancing and blood glucose level measuring device (wherein communication section 67 transmits a blood sugar measurement result, which is interpreted as blood glucose level data, from an optical reading section, which is interpreted as the blood glucose level measuring unit, to an injection apparatus, which is interpreted as the user device, that is communicatively connected to blood test apparatus 11-2; ¶¶ [0113]-[0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the casing (of Choi, Matsumoto, and Choi ‘131) to further incorporate a communication module as taught by Matsumoto for the benefit of automatically setting an insulin dosage amount in an injection apparatus and therefore reducing the risk of patient error in programming a dosage amount (Matsumoto, ¶ [0097]).
Regarding claim 9, the combination of Choi, Matsumoto, and Choi ‘131 teaches the lancing and blood glucose level measuring device of claim 1 as discussed above. Choi ‘131 further teaches 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 (slid sensor is a pressure sensor configured to sense a backward slide of a mounting plate on which the spacer barrel and the beam barrel are mounted whereby laser resonator 100 generates a laser beam if the pressure measured by the pressure sensor is equal to or higher than a predetermined pressure; ¶¶ [0089]-[0090]; Fig. 4).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Matsumoto and Choi ‘131 as applied to claim 1 above, and further in view of Siu et al. (U.S. Pat. Pub. No. 2019/0090791; hereinafter “Siu”).
Regarding claims 2-3, the combination of Choi, Matsumoto, and Choi ‘131 teaches the lancing and blood glucose level measuring device of claim 1 as discussed above. However, Choi in view of Matsumoto and Choi ‘131 does not explicitly teach wherein the blood glucose strip includes a blood absorbing member formed of a super absorbent polymer to absorb blood remaining and exposed at a peripheral portion of the blood glucose sensor as recited in claim 2, and further wherein the super absorbent polymer is spaced apart from the blood glucose sensor by a predetermined distance as recited in claim 3.
Siu, in the analogous art of sensor devices for testing biological and other liquid samples, teaches a blood absorbing member formed of a super absorbent polymer to absorb blood remaining (separators 602 formed of a superabsorbent polymer – separators 602 are capable of absorbing blood remaining and therefore are interpreted as the blood absorbing member; ¶ [0049]; Fig. 6) and exposed at a peripheral portion of a sensor (separators 602 are positioned between the test pads, i.e., peripheral portions of sensors, on the upper surface of the immunoassay strip 302 to serve as a separation wall; ¶ [0049]; Fig. 6). Siu further teaches wherein the super absorbent polymer is spaced apart from the sensor by a predetermined distance (wherein first separator on the far left of separators 602 is spaced apart from test pad B; ¶ [0049]; Fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood glucose strip (of Choi in view of Matsumoto and Choi ‘131) to incorporate a blood absorbing member as taught by Siu and position the blood absorbing member at a peripheral portion, and spaced apart by a predetermined distance, of the blood glucose sensor (of Choi in view of Matsumoto and Choi ‘131) for the benefit of controlling the amount of liquid analyte to be tested (Siu, ¶ [0049]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Matsumoto and Choi ‘131 as applied to claim 1 above, and further in view of Cunningham et al. (U.S. Pat. Pub. No. 2002/0169393; hereinafter “Cunningham”).
Regarding claim 4, the combination of Choi, Matsumoto, and Choi ‘131 teaches the lancing and blood glucose level measuring device of claim 1 as discussed above. However, Choi in view of Matsumoto and Choi ‘131 does not explicitly teach 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, in the analogous art of apparatus for extracting a sample of blood for glucose monitoring, teaches an apparatus for collecting a sample of body fluid for analysis in a diagnostic test, e.g., blood, (see ¶ [0019]) comprising a heating member configured to apply heat around the irradiation target area (heating element to increase the availability of blood to the area of the skin, i.e., the irradiation target area, from which the sample is to be extracted; ¶¶ [0024] and [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Choi in view of Matsumoto and Choi ‘131 to further incorporate a heating member as taught by Cunningham for the benefit of increasing the availability of blood to the area of the skin from which the sample is to be extracted (Cunningham, ¶ [0026]).
The combination of Choi, Matsumoto, Choi ‘131, and Cunningham does not explicitly teach wherein the heating member is formed on yet another part of one side of the casing. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the heating member on yet another part of one side of the casing as a mere engineering design choice for the benefit of providing access to the heating element to heat the area of the skin from which the sample is to be extracted.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Choi, Matsumoto, Choi ‘131, and Cunningham to position the heating member on yet another part of one side of the casing because such modification merely involves a rearrangement of parts that would not have modified the operation of the device. See MPEP 2144.04(VI)(C) regarding rearrangement of parts; see also In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
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 Steven R. Castaneda whose telephone number is (571)272-0998. The examiner can normally be reached Monday through Friday 10am - 6pm ET.
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/STEVEN RAY CASTANEDA/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797