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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-14, in the reply filed on 10/08/2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious burden on the examiner if restriction is not required and that it would be more efficient to examine all claims at once. This is not found persuasive because the issue as to the meaning and intent regarding “independent and distinct” as used in 35 U.S.C 121 and 37 CFR 1.41 has been adequately addressed in MPEP §802.01. Therein, it is stated that the legislative intent was to maintain the substantive law on the subject of restriction practice prior to enactment of 35 USC 121. Such practice permitted restriction between distinct, albeit dependent inventions. If the intent had been otherwise, then only the term “independent” would have been used. Thus, restriction between the distinct inventions set forth in this application is proper even though these inventions are clearly related.
With regard to applicants allegation that joinder of these distinct inventions would not present a serious burden to the U. S. Patent and Trademark Office, such allegations relied on the unsupported assumption that the search and the examination of both the invention would be coextensive. Further, while there may be some overlap in the searches of the two inventions, there is no reason to believe that the searches would be identical. Please see the restriction mailed 08/27/2025 page 3 which sets forth the burden. Therefore, based on the additional work involved in searching and examining both distinct inventions together, restriction of the distinct inventions is clearly proper and is therefore made FINAL.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/08/2025.
Status of Claims
Claims 1-16 remain pending in the application, with claims 1-14 being examined and claims 15-16 being withdrawn pursuant to the election filed 10/08/2025.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “to the top surface by an angle of from 5
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° to 25°.” on lines 1-2, where it sounds like there is a word or phrase missing. Should it be “to the top surface by an angle of
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° to 25°.”?
Appropriate correction is required.
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 1-14 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 “a body fluid sample” on line 5, where it is unclear if this body fluid sample is the same or different from the body fluid recited on line 2.
For examination, it will be interpreted that they are the same body fluid sample.
It is suggested to amend line 5 to recite “[[a]] the body fluid sample”
Claims 2-14 are rejected by virtue of being dependent on a rejected claim.
Claim 4 recites “towards a central region of the test strip fixation device, a central region of the test strip fixation device provides a maximum height of the test strip fixation device, and the central region has a planar surface.” on lines 5-7. It is unclear if the first and second “central region” are the same or not. If they are different from one another, then it is also unclear which of the two “the central region” is referring to.
For examination, it will be interpreted that they are all the same central region.
It is suggested to amend line 5 to recite “towards a central region of the test strip fixation device, [[a]] the central region of the test strip fixation device”
Claim 11 recites “said optical test strip comprising a carrier and a reagent test region” on lines 2-3. Even though the optical test strip is not positively recited in claim 1, claim 11 is now positively reciting the optical test strip. It is unclear if the reagent test region is the same or different from the one described in claim 1.
For examination, it will be interpreted that is the same.
It is suggested to amend claim 11 to recite “said optical test strip comprising a carrier and [[a]] the reagent test region”
Claims 12-14 are rejected by virtue of being dependent on a rejected claim.
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) 1-3, 5-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Ko (KR-102094780-B1) in view of Adiri (US-2020/0126226-A1) and Maher (US-2008/0081341-A1).
Regarding claim 1, Ko teaches a test strip fixation device (urine test kit 210) for use in a method for determining concentration of an analyte in a body fluid using a mobile device with a camera, said test strip fixation device (210) comprising ([0043], Figure 2):
a) a top surface and a bottom surface and having an essentially planar shape (see Figure 2 where the top surface is the surface that includes colorimetric cells 221 and the bottom surface is the bottom surface of the sample rod mounting groove H. Both of these surfaces are essentially planar);
b) a cut-out portion (mounting groove H) configured for application of a body fluid sample ([0047] see the sample mounting groove H is formed to be long in the vertical direction open at the lower end and shielded at the upper end by urine examination kit 210, and where biochemical sample rod 220 is inserted while being fixed to the top of the sample rod mounting groove H. Therefore, the mounting groove H is a cut-out portion of the urine examination kit 210 that will have the bottom surface. In Figure 2 there is a dashed rectangle surrounding the mounting groove H);
c) the top surface comprising a plurality of color reference (colorimetric cells 221) fields having known reference color values, including non-grey reference fields ([0047], [0053] see color of the colorimetric cell obtains the RGB value from the color extraction point 610, and since there is standard data with a set color, correction for color changes according to the surrounding environment is possible so the latent color extracted from the center of the colorimetric cell can be used as is without additional work); and
The limitations “a test strip fixation device for use in a method for determining concentration of an analyte in a body fluid using a mobile device with a camera” and “a cut-out portion configured for application of a body fluid sample” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Ko and the apparatus of Ko is capable of being used with a mobile device with a camera, and the mounting groove is capable of having a body fluid sample applied to it. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Ko (see MPEP §2114).
Further, please note that the mobile device with a camera and the body fluid sample have not been positively recited in the claim, and are therefore not part of the claimed test strip fixation device.
While Ko does describe a white balancing step that compensates for color variations in the image, this is by using a color constancy algorithm so the image has constant color expression independent of external factors (Ko; [0019]), Ko does not teach grey reference fields. Additionally, Ko does not teach position detection code elements.
In the same problem solving area of analyzing visible chemical reactions, Adiri teaches grey elements and position markers (Adiri; abstract, [0080], [0089]).
Specifically, Adiri teaches where a colorized surface 132 includes a plurality of calibration elements that include grey elements 465 and colored reference elements 470 (Adiri; [0080], Figure 4B). The grey elements 465 exhibit various shades of grey for improved gamma correction, where it is seen in Figure 4B that the grey elements 465 have three sides each having a different shade of grey (Adiri; [0081], [0082]). Additionally, Adiri teaches where a color board includes a unique QR code 515 that may reflect specific chromatic properties associated with at least some of the plurality of colored reference elements at a time of printing, where it is further seen in Figure 5A that there are position markers in each of the corners (Adiri; [0089] see position markers 474 and 475 in Figure 4B that are understood to also be in Figure 5A, [0091]).
It would have been obvious to one skilled in the art to modify the colorimetric cells of Ko such that they also include grey elements of various shades as taught by Adiri because Adiri teaches that the grey elements allow for improved gamma correction (Adiri; [0081]). Additionally, it would have been obvious to one skilled in the art to modify the urine test kit of Ko to include the position markers and the QR code (together making up position detection code elements) as taught by Adiri because Adiri teaches that the position markers allows for the determination that a reagent pad is in a desired orientation or not and because the QR code provides information on the color board, geographical region, production line, creator of the color board, health care provider, type of desired medical test, attributes of a user, specific chromatic properties, and a range of chromatic properties (Adiri; [0103], [0120]).
The colorimetric cells 221 will still be aligned with the plurality of pad cells 211 formed on the biochemical sample rod 220 as seen in Figure 2 of Ko, where the grey elements of Adiri will be between each row of colorimetric cells 221 similar to how they are arranged in Figure 4B of Adiri. Thus, the grey elements will be symmetrically arranged around the sample rod mounting groove (cut-out portion) and they will also be around the colorimetric cells 221. The position markers and QR code of Adiri will also be placed on the urine test kit 210 similar to how they are placed in Figure 5A of Adiri.
Ko does teach that the biochemical sample rod is inserted and fixed to the top of the sample rod mounting groove, but does not teach how it is fixed specifically (Ko; [0047]).
In the same problem solving area of holders for a test strip, Maher teaches retention features (Maher; [0016]).
Specifically, Maher teaches a holder 2 of a device 1 used to hold a lateral flow test strip 4, where the holder 2 is shaped to provide support structure for the test strip 4 (Maher; [0054], Figures 1, 2). The holder 2 is seen to have lower retention features 8 best seen in Figure 3 to secure absorbent pads (Maher; [0058]).
It would have been obvious to one skilled in the art to modify the sample rod mounting groove of Ko such that it includes the retention features as taught by Maher because Maher teaches that the retention features hold and secure absorbent pads (Maher; [0054], [0058]).
The limitation “a connector configured for detachable connection of an optical test strip to the test strip fixation device and for alignment of a reagent test region of the test strip with the cut-out portion.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Maher and the retention elements of Maher are capable of detachably connecting an optical test strip and aligning a reagent test region of the test strip with the cut-out portion. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Maher (see MPEP §2114).
Further, the optical test strip has not been positively recited in the claim, and is therefore not a part of the test strip fixation device.
Regarding claim 2, modified Ko teaches the test strip fixation device according to claim 1. Ko further teaches wherein:
the test strip fixation device (210) comprises first and second pairs of outer edges arranged essentially parallel to one another (Ko; see Figure 2); and
the test strip fixation device (210) has an essentially rectangular shape and the outer edges of the first pair are longer than the outer edges of the second pair (Ko; see Figure 2 where the urine test kit 210 is rectangular in shape with a first and second pair of outer edges that are essentially parallel to one another).
Regarding claim 3, modified Ko teaches the test strip fixation device according to claim 2. Ko further teaches wherein:
the cut-out portion (sample rod mounting groove H) is located in a central area of the test strip fixation device (210) relative to the first and second pair of outer edges (Ko; see Figure 2 where the dashed rectangle defining the sample rod mounting groove H is in a central area of the device relative to the edges of the urine test kit);
Regarding claim 5, modified Ko teaches the test strip fixation device according to claim 1. The bottom surface of the sample rod mounting groove of Ko is a planar surface of a central region of the urine test kit 210. The central surface is the bottom surface, and this would deviate from the top surface since it is a groove.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to determine, through routine experimentation, the optimum deviation of the bottom surface relative to the top surface to a range of 5
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° to 25° which would ensure that the groove would be recessed below the top surface (MPEP § 2144.05 (II)).
Additionally, one of ordinary skill in the art would find it obvious to change the shape of the test strip fixation device such that planar surface of a central region of the test strip fixation device deviates from a parallel orientation relative to the top surface by an angle of from 5
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° to 25° because the change in shape is a matter of choice a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration is significant, please see MPEP 2144.04 IV B.
Regarding claim 6, modified Ko teaches the test strip fixation device according to claim 1. Ko has been modified with Adiri to include the grey elements, position markers and QR code as seen in Figure 5A of Adiri. The position markers and QR code are seen to be located essentially at the outer edges of the device seen in Figure 5A of Adiri, and will be placed similarly on the urine test kit of Ko.
Regarding claim 7, modified Ko teaches the test strip fixation device according to claim 1. Adiri further teaches wherein:
the position detection code elements comprise information specific to the test strip fixation device, said information comprising at least lot-specific information and/or calibration information relating to the color reference fields (Adiri; [0120] see where QR code is unique to the color board, geographical region, production line, creator of the color board, health care provider, a type of desired medical test, attributes of a user of the color board, specific chromatic properties, a range of chromatic properties. Where the QR code is a part of the position detection code elements).
Regarding claim 8, modified Ko teaches the test strip fixation device according to claim 1. Adiri further teaches wherein the grey reference fields comprise at least three different grey shades (Adiri; [0082] see cube-like grey elements 465 have three sides each having a different shade of grey).
The grey elements of Adiri will be arranged locally around the sample rod mounting groove H of Ko, and will also be arranged locally around some of the colorimetric cells similar to how they are arranged seen in Figure 4B of Adiri.
Regarding claim 9, modified Ko teaches the test strip fixation device according to claim 1. Maher further teaches wherein the connector comprises one or more guides (Maher; see Figure 2 where the retention elements 8 are guides that make up the connector. The retention elements are guides because they guide a user to properly insert a test strip, where proper insertion would have the strip engaged with all the retention elements).
Regarding claim 10, modified Ko teaches the test strip fixation device according to claim 1. The method of the top surface and the bottom surface, including the connector, are formed as a one-piece injection molded part, wherein the color reference fields and the position detection code elements are applied to the top surface by a printing process, or wherein the color reference fields and the position detection code elements are printed onto a label which is applied to the top surface is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by modified Ko (MPEP § 2113). Here, the limitations as to the top surface, bottom surface, and connector being formed as a one piece injection molded part and the color reference filed and position detection code elements being applied by a printing process or the color reference fields and position detection code elements are printed on a label which is then applied to the top surface are process limitations in an apparatus/product claim. The burden is on applicants to show product differences in product-by-process claims.
Regarding claim 11, modified Ko teaches the test strip fixation device according to claim 1. Ko further teaches further comprising the optical test strip (biochemical sample rod 220), said optical test strip (220) comprising a carrier and a reagent test region (plurality of pad cells 211) for application of the sample of body fluid, said reagent test region (220) being arranged on said carrier and said carrier having a transparent zone at the location of said reagent test region (220) (Ko; [0046] where the sample rod 220 is the optical test strip, the rod itself is a carrier that carries the plurality of pad cells 211 seen in Figure 2. Further, as the color of the plurality of pad cells 211 is being observed there are transparent zones at each of the pad cells 211).
The limitation “which is adapted to be detachably connected to the connector” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Ko and the biochemical sample rod of Ko is capable of being detachably connected to the retention elements of Maher. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Ko (see MPEP §2114).
Further, the sample of body fluid has not been positively recited in the claim, and is therefore not a part of the test strip fixation device.
Regarding claim 12, modified Ko teaches the test strip fixation device according to claim 11. Ko further teaches wherein the cut-out portion (sample rod mounting groove H) of the test strip fixation device (210) has a size no smaller than the reagent test region (pad of cells 211) (Ko; see Figure 2 where the sample rod mounting groove H will be larger than one of the pads of cells 211).
Regarding claim 13, modified Ko teaches the test strip fixation device according to claim 12. Ko has been modified to include the retention elements of Maher. The sample rod mounting groove H is seen in Figure 2 of Ko defined by the dashed rectangle. When the biochemical sample rod 220 is inserted into the sample rod mounting groove H and is retained by the retention elements of Maher, the whole sample rod 220 (including the rod itself) will be observable.
Regarding claim 14, modified Ko teaches the test strip fixation device according to claim 11. Ko further teaches wherein:
the test strip fixation device (210) comprises first and second pairs of outer edges arranged essentially parallel to one another (Ko; see Figure 2);
Ko has been modified by Maher to include the retention elements best seen in Figure 2. The retention elements will extend inward perpendicularly relative to the long side of the urine test kit 210 of Ko.
It is seen in Figure 2 of Ko that the sample rod 220 extends beyond the lower edge of the urine test kit 210, however Ko does not teach how far the rod extends.
It would have been obvious to one skilled in the art at the time the invention was filed, to determine, through routine experimentation, the optimum amount that the sample rod extends beyond the lower edge to a range of at least 5 mm which would allow for the user to properly hold the sample rod 220 while inserting and removing the sample rod from the urine test kit (MPEP § 2144.05 (II)).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated Ko (KR-102094780-B1), Adiri (US-2020/0126226-A1) and Maher (US-2008/0081341-A1), and in further view of Martin (US-2009/0197296-A1).
Regarding claim 4, modified Ko teaches the test strip fixation device according to claim 1. Ko does not teach wherein:
the test strip fixation device has a height of no more than 10 mm, including the top surface, the bottom surface and the connector; and/or
In the analogous art of assay devices that include a sample contact zone and a detection zone with a colorant indicator, Martin teaches a support substrate adjacent to a porous membrane (Martin; abstract, [0029]).
Specifically, Martin teaches where a panel 13 includes a color reference 15 and data interpretation guide 17 that helps a user compare colors when reading the test results, where these components are on support substrate 11 as seen in Figure 2A (Martin; [0021], [0029]). It is further described by [0030] that porous membrane 21 is set onto support 11, and [0029] describes that the support 11 has a certain minimum thickness to provide sufficient structural backing for porous membrane 21, for example a thickness of about 100 to about 5000 micrometers.
It would have been obvious to one skilled in the art to modify the urine test kit of Ko such that it has a thickness of about 100 to 5000 micrometers as taught by Martin because Martin teaches that this thickness is sufficient to provide sufficient structural backing for a porous membrane placed onto it (Martin; [0029], [0030]).
The overall thickness of the urine test kit, including the top and bottom surface, will be between 100 and 5000 micrometers. The retention elements are within the sample rod mounting groove H and will be within the defined thickness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796