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 .
Response to Amendment
Applicant’s amendment and remark filed on 05/18/26 have been entered. Claims 1, 3-8, 10-14, and 16-24 remain pending. Claims 2, 9, and 15 have been canceled, and new claims 18-24 have been added. Claims 8 and 10-14 have been withdrawn. Claims 1, 3-7, and 16-24 are examined herein.
Status of Rejection
The 103 rejection of claims 1, 3-7, and 16-17 is maintained.
Claims 21-24 are withdrawn by election of original presentation.
Election/Restrictions
Newly submitted claims 21-24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1, 3-7, and 16-20 drawn to an optical test strip comprising at least one carrier foil, wherein the carrier foil is bonded to the test strip carrier and has at least one wavelength filter component.
Group II, claim(s) 8 and 10-13, drawn to a method of using the optical test strip of Group I.
Group III, claim(s) 14, drawn to a test kit comprising the test strip of Group I.
Group IV, claim(s) 21-24, drawn to an optical test strip comprising layered carrier foil applied to the test strip carrier and have at least two filter layers configured to block light in two transmission spectra.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of:
an optical test strip for measuring the concentration of an analyte in a sample of blood, comprising:
a test strip carrier having at least one transparent area;
a test field, wherein the test field:
comprises at least one carrier foil; wherein the at least one carrier foil is applied to the test strip carrier and covers the at least one transparent area of the test strip carrier;
comprises at least one test chemical comprising glucose oxidase and/or glucose dehydrogenase applied to the carrier foil, the at least one test chemical being configured for performing an optical detectable detection reaction with the analyte, wherein the one test chemical is further configured for at least partially absorbing light having at least one absorption wavelength
λ
a
b
s
in the range 650 nm <
λ
a
b
s
<1100 nm.; and
comprises at least one porous material for at least partially filtering out solid components contained in the sample (A mesh 240, which allows a blood sample pass through) (Paragraph 59; Figure 4B);
wherein the at least one carrier foil has at least one wavelength filter component which is adapted to essentially block light having wavelengths
λ
b
l
c
of 10 nm <
λ
b
l
c
< WLlow, with 550 nm
≤
WLlow
≤
650 nm;
this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kwak (U.S. Pub. No. 2017/0343480 A1) in view of Ismail (U.S. Pat. No. 5,116,729) and evidential reference by Drozd (Pitfalls and capabilities of various hydrogen donors in evaluation of peroxidase-like activity of gold nanoparticles. 2016) as cited in previous Office Action.
Kwak discloses an optical test strip for measuring the concentration of an analyte in a sample of blood (A method for measuring blood glucose levels by a portable terminal using a strip module is provided) (Abstract), comprising:
a test strip carrier (cover case 500, Figure 5A) having at least one transparent area (hole for camera lens; see annotated Figure) (Figure 5A);
a test field, wherein the test field:
comprises at least one carrier foil); (transparent strip 220) (Figure 2), wherein the at least one carrier foil is applied to the test strip carrier and covers the at least one transparent area of the test strip carrier (Figure 7B);
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514
621
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Greyscale
comprises at least one test chemical (the chemical in the dye pad 210 that produces a color change) applied to the carrier foil, the at least one test chemical being configured for performing an optical detectable detection reaction with the analyte (The strip module includes a dye pad having a color that changes in response to a sample applied to the dye pad) (Abstract); and
comprises at least one porous material for at least partially filtering out solid components contained in the sample (A mesh 240, which allows a blood sample pass through) (Paragraph 59; Figure 4B);
wherein the at least one carrier foil has at least one wavelength filter component which is adapted to essentially block light having wavelengths
λ
b
l
c
of 10 nm <
λ
b
l
c
< WLlow, with 550 nm
≤
WLlow
≤
650 nm (the transparent strip 220 can function as a filter through which light source of a red wave area can pass) (Paragraph 61) (Wavelength of color red is 645-650 nm) (also interpreted as the wavelength filter component located within the carrier foil).
Kwak alone does not explicitly disclose the test chemical comprising glucose oxidase and/or glucose dehydrogenase and is further configured for at least partially absorbing light having at least one absorption wavelength
λ
a
b
s
in the range 650 nm <
λ
a
b
s
<1100 nm.
In an analogous art, Ismail discloses a test strip for detecting glucose comprising:
a reagent test pad and a reagent composition embedded in the reagent test pad, wherein the composition comprises glucose oxidase; 3,3',5,5'-tetramethylbenzidine indicator dye; a peroxidase; and a buffer (Claim 11). Furthermore, evidential reference Drozd discloses TMB products have a maximum absorption wavelength at 652 nm (Figure 4), and TMB oxidation product is typically measured at the absorption wavelength 652 nm (thus read on the limitation of “wavelength
λ
a
b
s
in the range 650 nm <
λ
a
b
s
<1100 nm”). As Kwak’s carrier foil already have the capability of selectively allowing wavelength of red (645-650 nm) to pass, it would have been obvious to one of ordinary skill in the art to have substituted the reagent composition of Ismail to the test field of the device of Kwak to derive the claimed invention. Ismail’s reagent composition prevents unwanted oxidation and mitigates adverse effect of atmospheric oxygen, moisture, and light, and enable the test strip to be stored for an extended period of time (Ismail, Col. 9, Line 59-Col. 10, Line 3) while also allowing for characterizing glucose concentration at absorption wavelength at 650 nm.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-24 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
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.
Claim(s) 1, 3, and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak (U.S. Pub. No. 2017/0343480 A1; cited in previous OA) in view of Ismail (U.S. Pat. No. 5,116,729), as evidenced by Drozd (Pitfalls and capabilities of various hydrogen donors in evaluation of peroxidase-like activity of gold nanoparticles. 2016) as cited in previous Office Action.
Regarding claim 1 and 3, Kwak discloses an optical test strip for measuring the concentration of an analyte in a sample of blood (A method for measuring blood glucose levels by a portable terminal using a strip module is provided) (Abstract), comprising:
a test strip carrier (cover case 500, Figure 5A) having at least one transparent area (hole for camera lens; see annotated Figure) (Figure 5A);
a test field, wherein the test field:
comprises at least one carrier foil); (transparent strip 220) (Figure 2), wherein the at least one carrier foil is bonded to the test strip carrier and covers the at least one transparent area of the test strip carrier (Figure 7B);
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514
621
media_image1.png
Greyscale
comprises at least one test chemical (the chemical in the dye pad 210 that produces a color change) applied to the carrier foil, the at least one test chemical being configured for performing an optical detectable detection reaction with the analyte (The strip module includes a dye pad having a color that changes in response to a sample applied to the dye pad) (Abstract); and
comprises at least one porous material for at least partially filtering out solid components contained in the sample (A mesh 240, which allows a blood sample pass through) (Paragraph 59; Figure 4B);
wherein the at least one carrier foil has at least one wavelength filter component which is adapted to essentially block light having wavelengths
λ
b
l
c
of 10 nm <
λ
b
l
c
< WLlow, with 550 nm
≤
WLlow
≤
650 nm (the transparent strip 220 can function as a filter through which light source of a red wave area can pass) (Paragraph 61) (Wavelength of color red is 645-650 nm) (also interpreted as the wavelength filter component located within the carrier foil).
Kwak alone does not explicitly disclose the test chemical comprising glucose oxidase and/or glucose dehydrogenase and is further configured for at least partially absorbing light having at least one absorption wavelength
λ
a
b
s
in the range 650 nm <
λ
a
b
s
<1100 nm.
In an analogous art, Ismail discloses a test strip for detecting glucose comprising:
a reagent test pad and a reagent composition embedded in the reagent test pad, wherein the composition comprises glucose oxidase; 3,3',5,5'-tetramethylbenzidine indicator dye; a peroxidase; and a buffer (Claim 11). Furthermore, evidential reference Drozd discloses TMB products have a maximum absorption wavelength at 652 nm (Figure 4), and TMB oxidation product is typically measured at the absorption wavelength 652 nm (thus read on the limitation of “wavelength
λ
a
b
s
in the range 650 nm <
λ
a
b
s
<1100 nm”). As Kwak’s carrier foil already has the capability of selectively allowing wavelength of red (645-650 nm) to pass, it would have been obvious to one of ordinary skill in the art to have substituted the reagent composition of Ismail to the test field of the device of Kwak to derive the claimed invention. Ismail’s reagent composition prevents unwanted oxidation and mitigates adverse effect of atmospheric oxygen, moisture, and light, and enable the test strip to be stored for an extended period (Ismail, Col. 9, Line 59-Col. 10, Line 3) while also allowing for characterizing glucose concentration at absorption wavelength at 650 nm.
Regarding claim 4, Kwak discloses the claimed invention as discussed above in claim 1. Kwak discloses the filter is a longpass filter (Kwak does not explicitly state the filter is longpass filter but the filter only allows red light to pass). Kwak discloses the light source used can be fluorescent light (…and the light source 310 of the mobile terminal 300 can be embodied as a fluorescent light) (Paragraph 52).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak in view of Ismail as discussed in claim 1 above, and as evidenced by GlobalSpec (Long Pass Filters and Short Pass Filters Information, February 2018) cited in previous OA.
Regarding claim 5, Kwak discloses the claimed invention as discussed above in claim 1. Kwak discloses the filter is a longpass filter (Kwak does not explicitly state the filter is longpass filter but the filter only allows red light to pass). Kwak discloses the light source used can be fluorescent light (…and the light source 310 of the mobile terminal 300 can be embodied as a fluorescent light) (Paragraph 52).
The limitation of “wherein the longpass filter has a transmission edge rising with wavelength of the light, wherein the long pass filter further has a characteristic wavelength…of a maximum transmission of the longpass filter” are interpreted to be functional limitation. In general, longpass filter has transmission edge rising with the wavelength of light and a specific characteristic wavelength. See Picture from GlobalSpec below.
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276
411
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Claim(s) 6, 7, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak in view of Ismail as discussed in claim 1 above, and further in view of Lundin (U.S. Pub. No. 2018/0246306 A1; as cited in previous OA).
Regarding claims 6, 7, 16, and 17 Modified Kwak discloses the claimed invention as discussed above in claim 1. Neither Kwak nor Ismail discloses the wavelength filter component comprises an interference filter or the carrier foil comprises at least one further filter component wherein the at least one further filter component comprises a shortpass filter.
In an analogous art, Lundin discloses a mobile microscopic device under fluorescent or LED light using a mobile phone (Paragraph 52-53). Lundin discloses a common/conventional problem relating to polymer lenses of the camera is auto fluorescence of polymer materials, which is disturbing at visible wavelengths (Paragraph 28). To correct the problem, Lundin discloses incorporating a low-pass (absorption) or an interference filter (LED used for excitation requires efficient low pass filters in order to block wave lengths at fluorescent emission spectrum. This excitation filter may be either based on dielectric interference filters or absorption filters) (Paragraph 85 and 87).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have alter the filter component to be an interference filter or including additional shortpass filter to account for auto fluorescence effect from polymeric camera lens of phone camera by blocking/eliminating undesired light transmission outside of the specified range as claimed.
Regarding claim 16 and 17, Modified Kwak discloses the claimed invention as discussed above in claim 6 and 7 respectively. The modification of claim 6 and 7 was done within the wavelength filter component (which is a part of the carrier foil) and therefore would have satisfied the limitation, “interference filter is located on at least one surface of the carrier foil” or “the carrier foil comprises the at least one further filter component.
Regarding claim 18, Modified Kwak discloses the claimed invention as discussed above. Kwak discloses the carrier foil carried foil comprises a layered structure including the at least one further filter component (see rejection of claim 15 above) and at least one layer of transparent matrix material (transparent film 140, Fig. 1B).
Regarding claim 19, Modified Kwak discloses the claimed invention as discussed above in claim 17. Kwak discloses the structure including an adhesive layer (guide 515, Fig. 5B) configured to bond the carrier foil to the test strip carrier (guiding rail 505, Fig. 5B; Fig. 5C).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwak in view of Ismail as discussed in claim 1 above, and further in view of Chou (U.S. Pub. No. 2020/0025686 A1).
Regarding claim 20, Modified Kwak discloses the claimed invention as discussed above in claim 1. Neither Kwak nor Ismail explicitly discloses the thickness of the carrier foil.
In an analogous art, Chou discloses a colorimetric device for blood (claim 25) glucose (para. [0092]) analysis, wherein the device is to be used with phone camera (Fig. 2C-2D). The sample is sandwiched between two plates, a first plate and a second plate (Fig. 3; analogous to Kwak’s device in which the sample pad is covered by a transparent film), wherein the second plate is a transparent flat film with thickness around 1 to 1000 microns (para. [0342]) with 10 to 300 microns to be preferable thickness so long the transparent film does not distort the sample (para. [0344]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated the thickness of 10 to 300 microns for the transparent film of Kwak’s device based on the teaching of Chou to derive the claimed invention. The selection is made to ensure the film dimension does not interfere with the absorption of color indicator/dye while ensuring the film does not distort the sample (The second plate is a transparent thin film with smooth surface. It is necessary that the absorption of second plate does not interfere with the absorption of color indicator. Depends on the flexibility of the material, thickness from 10 um˜300 um can be used as second plate, as long as no distortion of sample chamber will happen after second plate is pressed onto the sample. Para. [0344], Chou).
Response to Arguments
Applicant's arguments filed 05/18/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument with newly amended claim 1, the applicant amended the language such that the carrier foil is being “bonded” instead of “applied” to the test strip carrier. Applicant argues that this limitation would have further distinguished the invention over Kwak.
Examiner respectfully disagrees. Under broadest reasonable interpretation, the term “bonded” involves having two materials joined together. As long as the objects are firmly connected or joined, they would have been considered to be “bonded”. In this instance, the transparent strip 220 (interpreted to be the carrier foil) being slotted into the phone cover as shown in Fig. 5 would have been considered as being “bonded” (or detachably “bonded”). The intended definition of “bonded” according to the applicant with support from the specification is to be joined by adhesive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Something being “bonded” without explicitly reciting how the bonding happen (i.e. adhesive layer) is not sufficient to overcome the rejection of record. 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). For the reason above, the rejection of claims 1, 3-7, and 16-17 are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Pub. No. 2013/0052748 A1 discloses a test strip device with a first and second optical filter (para. [0034]-para. [0036] and Fig. 2) (the second optical filter will allow transmission of light of a shorter wavelength range than that of the first optical filter, for example the second optical filter may be a blue filter while the first optical filter may be a green filter. Especially the filters will be such that together they will block light in substantially the entire visible light range.). However, one optical filter is placed on top cover 8 and another optical filter is placed on the bottom transparent cover 6 (Fig. 3).
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 MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./ Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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