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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/19/2025 has been entered.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 9/19/2025. Claims 13-16 and 18-25 are pending in the application.
Status of Objections and Rejections
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
Applicant's arguments filed 9/19/2025 have been fully considered but they are not persuasive.
The Applicant remarks that Morita and Takinami in any combination do not teach or suggest "the maximum dimension of the aperture in the width direction is smaller than a minimum dimension of the flow path in the width direction," as recited in amended claim 13.
In response to this argument, the Examiner respectfully disagrees. Takinami teaches a device wherein the measurement position is smaller than the minimum dimension of the flow path so that it fits within the channel, see Fig. 6A and [0086] – [0087], where the use of the smaller measurement portion and widened entry port allows for the deposit of biological fluids in a smooth manner.
Status of Claims
Claims 13-16 and 18-25 are examined in the action below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “light receiving unit” in claim 15, where the unit is configured to receive the measurement light.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. This structure is a photodiode (see [0051] in the Specification).
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 13-22 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Morita et al. (US 2015/0185159), and further in view of Takinami (US 2017/0102336).
Regarding claim 13, Morita et al. teaches a component measurement system (analysis system A, see Fig. 2 and [0057]) comprising:
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Annotated Fig. 2
a test strip that comprises a main body portion for holding a sample (chip for analysis 1 with sheet bodies 10a-c for holding sample 3, see Fig. 4A and [0060]) and a flow path for introducing the sample to a measurement position (the channel 11 moves fluid through and therefore includes reaction chamber 12, see Fig. 4A-B), the flow path extending in a longitudinal direction (11, see Fig. 4A); and
a component measurement device (mobile terminal B and apparatus for analysis C, see Fig. 2 and [0057]) configured to optically measure a component contained in the sample (components of terminal B and apparatus C optically detect an analyte in sample 3, see [0059]), the component measurement device comprising:
a housing (4) defining:
a light emitting unit accommodation space located in an interior of the housing (area below chip mounting plate 23 where light sources 21 are located, see Fig. 2 and [0064]),
a light receiving unit accommodation space located in an interior of the housing (placing section 4a for holding mobile terminal B, see Fig. 2 and [0065]),
an insertion hole in which the test strip (1) is insertable, located between the light emitting unit accommodation space and the light receiving unit accommodation space (insertion port 23c for accepting chip 1 between space for light sources 21 and placing section 4a, see Fig. 2 and [0063]),
a light emitting-side passage opening located between the light emitting unit accommodation space and the insertion hole (see annotated Fig. 2, where the opening is located between the space for the light sources 21 and the insertion port 23c), and a light receiving-side passage opening located between the light receiving unit accommodation space and the insertion hole (light passing section 41 between the placing section 4a and insertion port 23c, see Fig. 2 and [0065]), a light emitting unit located in the light emitting unit accommodation space (light sources 21, see Fig. 2 and [0064]),
and a light receiving unit located in the light receiving unit accommodation space (mobile terminal B, see Fig. 2 and [0061]), wherein:
the light emitting unit is configured to emit measurement light traveling in a thickness direction of the main body portion (light from light sources 21 is transmitted through the chip 1, see Fig. 2 and [0065]),
the light receiving unit being configured to receive measurement light transmitted through the main body portion (light is received by mobile terminal B, see [0061])
the main body portion comprises a light shielding portion (light blocking cover 14 on top later 10a chip 1, see Fig. 4A-B and [0060]- [0061]),
the light shielding portion has an aperture defining a measurement position at which measurement light irradiates a reaction product of a reagent and the sample (reactions occur at opening sections 14a/reaction chambers 12 of cover 14 and light is transmitted through, see Figs. 2, 4A, [0061], and [0065]),
and a maximum dimension of the aperture in a width direction perpendicular to the longitudinal direction is smaller than a minimum dimension of the light emitting-side passage opening and a minimum dimension of the light receiving-side passage opening in a width direction (circular reaction chambers 12 are smaller than the circular light emitting side opening, see Fig. 1 and Annotated Fig. 2, and are smaller than the light transmitting section 41, see Figs. 1-2, [0065], and [0074]); and
However, Morita et al. does not teach that the maximum dimension of the aperture is smaller than a minimum dimension of the flow path in the width direction.
However, while Morita et al. does not explicitly teach an embodiment of the invention wherein the maximum dimension of the aperture in the width direction is smaller than a minimum dimension of the flow path in the width direction, the reference teaches that the aperture can be smaller than the measurement position (the opening 14a is smaller than the reaction chamber 12 of the flow path, see [0061]). The prior art Therefore, the difference between the instant invention and the prior art of Morita et al. was a known variation.
Further, in the analogous art of component measuring devices, Takinami teaches a device wherein the measurement position is smaller than the minimum dimension of the flow path so that it fits within the channel, see Fig. 6A and [0086] – [0087], where the use of the smaller measurement portion and widened entry port allows for the deposit of biological fluids in a smooth manner.
Additionally, there were design incentives for implementing the claimed variation. Specifically, the modification would have provided an outline to the coloring reaction that occurs in the reaction chamber, see [0061] in Morita et al. The modification of the measurement position to be smaller than the flow channel as exemplified by Takinami would have also had the benefit of moving fluid from an inlet to a reagent spot and allowing the photodetector to capture a reagent color change at a specific region along a test strip. Therefore, the modification of the aperture to be smaller than the reaction chamber would have been recognized as predictable to one of ordinary skill in the art.
Additionally, Morita et al. does not teach or suggest a light receiving unit accommodation space located in an interior of the housing.
However, in the analogous art of component measuring devices, Takinami teaches a device comprising a light receiving unit accommodation space located in an interior of the housing (storage space 74 holding a light receiving unit 72, see Fig. 4A and [0060]- [0061]). Modifying a component measuring device to include a light detector on the interior of the housing was known in the art before the effective filing date.
Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the device of Morita et al. to include the light receiving unit accommodation space within the housing as exemplified by Takinami for the benefit of enclosing the light detection means to prevent outside light interference in the spectral readings of the test strip (referred to as the measurement chip of Takinami). The modification of the device of Morita et al. to include the light receiving unit accommodation space of Takinami would have yielded the reasonable expectation of successfully facilitating the transmission of optical signals through a test strip and to a light detecting means.
Regarding claim 14, modified Morita et al. teaches the component measurement system according to claim 13, wherein: in a state in which the test strip (1) is attached to the component measurement device, the aperture is disposed inside the light emitting-side passage opening in a plan view (when inserted, light from the light sources 21 illuminates the reaction chambers 12 through the light emitting side opening, see annotated Fig. 2, [0073]- [0074]).
Regarding claim 15, modified Morita et al. teaches the component measurement system according to claim 13, wherein: in a state in which the test strip is attached to the component measurement device, the aperture is disposed inside the light receiving-side passage opening in a plan view, the light receiving unit being configured to receive the measurement light transmitted through the main body portion (when inserted, the reaction chambers 12 of chip 1 are located in line with the light passing section 41 where the light passes through the reaction chambers 12 and to the mobile terminal, see Fig. 2 and [0065]).
Regarding claim 16, modified Morita et al. teaches the component measurement system according to claim 13, wherein: the flow path (channels 11 including reaction chamber 12, see Fig. 4A-B and [0060]) comprises a cavity (reservoir 15, see Fig. 4A and [0060]) having an intake portion at one end of the test strip (reservoir 15 supplies sample from channels to reaction chambers 12, see Fig. 4A and [0060]).
Regarding claim 18, modified Morita et al. teaches the component measurement system according to claim 13, wherein: the light shielding portion is located on a planar surface portion of the test strip, and defines at least both sides of the measurement position in the width direction (light blocking cover 14 is on top sheet 10a of chip 1 and surrounds all sides of the reaction chamber 12, see Fig. 4A and [0061]).
Regarding claim 19, Morita et al. teaches the component measurement system according to claim 13, wherein: in a plan view, the aperture (14a) is located at a position overlapping a reagent portion of the test strip carrying the reagent (the opening 14a overlaps the reagent 13 on the chip 1, see Fig. 4B).
Regarding claim 20, modified Morita et al. teaches the component measurement system according to claim 13, wherein: the light shielding portion of the test strip is formed of a black film member having a light shielding ratio of 90% or more (light blocking cover 14 is a non-transmissive black film, which implies that no light reaches the next layer of the substrate which would have a light shielding ration of >90%, see [0061]).
Regarding claim 21, modified Morita et al. teaches the component measurement system according to claim 13, wherein: the reagent is adapted to react with blood such that the reagent is colored in accordance with an amount of glucose in the blood (the reagent reacts with a blood sample 3 and produces a response corresponding to an analyte in a sample, see [0057]- [0059]).
Inclusion of the material or article worked upon by a structure, in this case being blood and the glucose concentration therein, being claimed does not impart patentability to the claims. In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 22, modified Morita et al. teaches the component measurement system according to claim 13, wherein: the main body portion (sheets 10a-c) of the test strip comprises:
a spacer layer that has the flow path comprising a cavity (reservoir 15), the flow path having an intake portion located at one end of the test strip (sheet 10b with channels 11 outlined therein with reservoir at one end, see Fig. 4B and [0060]), and
a first cover layer and a second cover layer that cover upper and lower surfaces of the spacer layer (sheets 10a and 10c that enclose channels 11 of sheet 10b, see Fig. 4B and [0060]).
Regarding claim 24, modified Morita et al. teaches the component measurement system according to claim 22, wherein: a ratio of a length of the intake portion along a minor axis direction of the main body portion to a width of the flow path is 0.45 or more and 1.82 or less (the width along the channel 11 is consistent prior to branching, and therefore has a ratio of 1 which falls within the instant range, see Fig. 4A-B and [0060]).
Regarding claim 25, modified Morita et al. teaches the component measurement system according to claim 22, wherein :the a light shielding layer (14), the spacer layer (10b), the first cover layer (10a), and the second cover layer (10c) are stacked so as to define, in the main body portion, an air vent portion that is open in at least one surface of the test strip and that is configured to allow air from the flow path to be vented (light blocking cover 14 and sheets 10a-c are stacked and accommodate air vents 11a to vent air from channels 11, see Fig. 4A-B and [0060]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Morita et al. (US 2015/0185159), and further in view of Takinami (US 2017/0102336)as applied to claim 22 above, and further in view of Cai et al (US 6,767,441).
Regarding claim 23, modified Morita et al. teaches the component measurement system according to claim 22, wherein: in a plan view, the intake portion has a quadrangular shape (the reservoir has the shape of a trapezoid, which is a quadrangle, see Fig. 4B), but does not teach that a ratio of a length of the intake portion along a minor axis direction of the main body portion to a length of the intake portion along a major axis direction of the main body portion is 0.5 or more and 3 or less.
However, in the analogous art of sensors for detecting analytes in a biological sample, Cai et al. teaches a ratio of a length of the intake portion (U-shaped cutout 42, see Fig. 2 and Col. 16, Lines 20-25) along a minor axis direction of the main body portion to a length of the intake portion along a major axis direction of the main body portion is 0.5 or more and 3 or less (the length of the fluid channel 112 is 5.2mm (major axis) where the width is 1.65mm (minor axis), see Col. 16, Lines 26-47, the ratio is equal to 3.12, or 3, which falls within the Instant Application's range).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the reservoir 15 of Morita et al. to have a ratio between the minor and major axes of the main body portion (sheet bodies of Morita) to match the ratio of Cai et al. for the benefit of providing a predetermined amount of sample to a chamber, or measurement position, of the sensor (see Col. 16 and Lines 18-25 in Cai et al.). The modification of the sheet bodies (main body portion) of Morita et al. to have the dimensions of Cai et al. would have a reasonable expectation of successfully facilitating capillary flow from one end of a channel to the other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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/A.N.M./Examiner, Art Unit 1758
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758