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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/25/2025 has been entered.
Response to Amendment
Applicant amendments filed 09/25/2025 have been entered.
Status of Claims
Claims 1-21 remain pending in the application, with claims 12-21 being examined and claims 1-11 being withdrawn pursuant to the election filed 09/23/2024.
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.
Claim 14 is 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 14 recites “defines an opening” on line 2, where it is unclear if this opening is the same or different from the test strip opening recited on line 6 of claim 12.
For examination it will be interpreted that they are the same opening.
It is suggested to amend claim 14 to recite “wherein one of the upper part and the lower part defines [[an]] the test strip opening”
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 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) 12-16, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenkranz (US-2013/0273528-A1) in view of Pitesky (US-5931794-A).
Regarding claim 12, Ehrenkranz teaches an accessory for a mobile device to measure characteristics of a test strip, the accessory comprising:
a test strip adapter comprising a sheath (assay housing 320) and a first interlock (see annotated Figure 5A below) ([0059], Figure 5A); and
a phone adapter (main body housing 310) ([0059], Figure 5A).
Annotated Figure 5A appears below showing the assay housing 320 specifically, where the two dashed arrows are pointing to elongated flanges which are the first interlock.
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[0061] of Ehrenkranz describes that the assay housing 320 is fixedly coupled to the main body housing 310, however Ehrenkranz does not teach how these two components are fixed.
In the same problem solving area of fastening two components together, Pitesky teaches where two or more trays can be fastened together by male and female portions (Pitesky; column 4 lines 3-10).
Specifically, Pitesky describes that these male and female portions are such that one tray can be slip fit into another in tongue-and-groove fashion (Pitesky; column 4 lines 5-10). As seen in Figure 3 two trays are coupled together by sliding the tongue 72 of one tray into the open end of the dovetail groove 74 of the adjacent tray to ensure longitudinal alignment (Pitesky; column 8 lines 13-18).
It would have been obvious to one skilled in the art to modify the main body housing of Ehrenkranz such that it has a corresponding groove as taught by Pitesky because Pitesky teaches that matching tongue-and-grooves enable two components to be coupled together and ensures longitudinal alignment (Pitesky; column 8 lines 13-18).
The flanges (tongues) of the assay housing 320 seen above in annotated Figure 5A will slide into corresponding grooves of the main body housing 310, and this will frictionally lock the two components together. Further, as seen in Figure 5A of Ehrenkranz there is an opening provided that has optical fiber device/light pipe 340 being inserted into it, and therefore when the assay housing 320 and main body housing 310 are joined the test strip (lateral flow immunoassay cassette 105) will be viewed via this opening which is within the flanges (first interlock).
The limitation “wherein in response to the first interlock being frictionally locked to the second interlock, the test strip is viewed via a test strip opening within the first interlock.” 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 Ehrenkranz and the apparatus of modified Ehrenkranz is capable of frictionally fitting the first and second interlocks and capable of viewing the test strip via a test strip opening. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Ehrenkranz (see MPEP §2114).
Additionally, it is noted that the mobile device and the test strip have not been positively recited by the claim, and are therefore not a part of the accessory.
Regarding claim 13, modified Ehrenkranz teaches the accessory of claim 12. Ehrenkranz further teaches wherein the sheath (320) comprises an upper part and a lower part and is configured to receive the test strip in any of the upper part and the lower part (Ehrenkranz; the surface of the assay housing 320 that directly connects to the flanges as seen in annotated Figure 5A supra is a lower part, and the upper part is the rest of the assay housing 320. As described by [0061] the assay housing 320 includes a cassette port 270 that is configured such that a lateral flow immunoassay cassette 105 can be inserted into the assay housing. The cassette port 270 is on the upper part of the assay housing 320).
The limitation “is configured to receive the test strip in any of the upper part and the lower part.” 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 Ehrenkranz and the apparatus of Ehrenkranz is capable of receiving the test strip in either upper or lower part. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Ehrenkranz (see MPEP §2114).
Further, the test strip has not been positively claimed, and is therefore not a part of the accessory.
Regarding claim 14, modified Ehrenkranz teaches the accessory of claim 13. Ehrenkranz further teaches wherein the lower part defines an opening to expose a portion of the test strip under a light transmitted from a portion of a screen of the mobile device (Ehrenkranz; see claim 13 supra where the lower part is the surface of the assay housing 320 that directly connects to the flanges as seen in annotated Figure 5A supra, the flanges have the opening within them and the opening is in the lower part).
The limitation “an opening to expose a portion of the test strip under a light transmitted from a portion of a screen of the mobile device.” 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 Ehrenkranz and the apparatus of Ehrenkranz is capable of exposing a portion of the test strip under a light transmitted from a portion of a screen of the mobile device. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Ehrenkranz (see MPEP §2114).
Further, the test strip nor the mobile device have been positively recited in the claim, and are therefore not a part of the accessory.
Regarding claim 15, modified Ehrenkranz teaches the accessory of claim 12. Ehrenkranz has been modified such that the main body housing has a corresponding groove for which the flanges of the assay housing may be inserted (see annotated Figure 5A for the flanges). The flanges are an insert.
Regarding claim 16, modified Ehrenkranz teaches the accessory of claim 12. Ehrenkranz further teaches wherein the phone adapter (310) comprises (Ehrenkranz; Figure 5A):
a base (see annotated Figure 5A below which shows the main body housing 310 specifically, where the surface that the back of the phone rests defines a base, the dashed arrow on the left is pointing to this area);
a lid (see annotated Figure 5A below showing the main body housing 310 specifically, where the opposite surface to the one that the phone rests on is a lid, the dashed arrow on the right is pointing to this surface); and
a light guide disposed between the base and the lid (Ehrenkranz; [0062] describes where the hand held device’s 250 light source can be used to illuminate the lateral flow immunoassay cassette 105, therefore there would need to be a channel between the base to the lid to allow light to pass through).
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Regarding claim 19, modified Ehrenkranz teaches the accessory of claim 16. Ehrenkranz further teaches wherein the base comprises a fastener that dimensionally fits over the mobile device to secure the phone adapter on the mobile device (Ehrenkranz; [0060] describes the main body housing 310 is shaped such that handheld device 250 is slid into the main body housing 310 such that device 250 clicks into or otherwise securely mates with the housing 310. See Figure 6 which shows housing 310 fitting over device 250, the part that goes over the front face of the phone is part of the base).
Further, please note that the mobile device has not been positively recited and is therefore not a part of the claimed accessory.
Regarding claim 20, modified Ehrenkranz teaches the accessory of claim 16. Ehrenkranz has been modified by Pitesky such that the main body 310 has corresponding grooves that allow the assay housing’s 320 flanges to be slid into. These grooves are ports.
Regarding claim 21, modified Ehrenkranz teaches the accessory of claim 12. Ehrenkranz further teaches wherein the test strip adapter includes a cover (sealing gasket 350), the cover (350) defining a slot (port 270) to receive the test strip (Ehrenkranz; the assay housing 320 and the flanges make up the test strip adapter, where it is seen in Figure 5B that the assay housing 320 includes cassette port 270 and gasket 350, [0066], Figures 5A-B).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenkranz (US-2013/0273528-A1) and Pitesky (US-5931794-A) and in further view of Cong (US-2016/0381265-A1).
Regarding claim 17, modified Ehrenkranz teaches the accessory of claim 16. Ehrenkranz further teaches wherein the base defines a light port located over a portion of a screen of the mobile device (Ehrenkranz; [0062] describes where the hand held device’s 250 light source can be used to illuminate the lateral flow immunoassay cassette 105, therefore there would need to be a channel between the base to the lid to allow light to pass through. Furthermore, the channel would need ports at either end to allow light to travel through the channel to the other side. Therefore there is a light port on the base).
Please note that the mobile device has not been positively recited and is therefore not part of the claimed accessory.
Ehrenkranz does not teach a camera hole over a camera of the mobile device.
In the analogous art of cassette attachment devices for measuring band intensities of test strip cassettes, Cong teaches where the attachment device includes windows (Cong; [0010], [0014], [0017]).
Specifically, Cong teaches a cassette attachment device 100 that includes a camera window 120 that fits a camera component of a mobile device as well as a flash window 124 so that the flash component of a mobile device can flash light into the window such that the mobile device can be the light source (Cong; [0014], [0017], Figures 1-4).
Ehrenkranz is silent with regards to specific configuration of the openings in the main body housing, therefore, it would have been necessary and thus obvious to look to the prior art for conventional main bodies that work with phones to image a test strip. Cong provides this conventional teaching showing that it is known in the art for an attachment device to include both a camera hole and a separate hole for the flash (light source). Therefore, it would have been obvious to one having ordinary skill in the art to make the main body housing of Ehrenkranz have separate ports for the camera and the light source as it is taught by Cong that this configuration is effective for attachment devices that use a phone to analyze a test strip.
The base of the main body housing 310 will have a camera hole.
Please note that the mobile device has not been positively recited in the claim, and therefore the mobile device is not a part of the claimed accessory.
Regarding claim 18, modified Ehrenkranz teaches the accessory of claim 17. Ehrenkranz has been modified with Cong such that now the main body housing will have separate windows for the light source and the camera. Therefore, the light path will be: handheld device’s 250 light source, through the light port, through the channel that connects the two sides of the main body housing 310, to the test strip, back through via the separate hole for the camera. [0063] of Ehrenkranz describes that there is at least one wavelength filter interposed between the light source and the lateral-flow chromatographic immunoassay cassette 105.
Response to Arguments
Applicant’s arguments, see page 6, filed 09/25/2025, with respect to the rejection(s) of claim(s) 12-15 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ehrenkranz (US-2013/0273528-A1) in view of Pitesky (US-5931794-A).
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