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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/24/2026 has been entered.
Response to Amendment
The Amendment filed 03/24/2026 has been entered. Claims 1-3 and 5-23 remain pending in the application. Claims 14-21 are withdrawn. Claims 1-3, 5-13 and 22-23 are being examined herein.
Status of Objections and Rejections
The claim objection of claim 3 is being withdrawn in view of Applicant’s amendment.
The rejection of claim 22 under 35 U.S.C 112(b) is being withdrawn in view of Applicant’s amendment.
New grounds for rejection under 35 U.S.C. 112(a) are necessitated by Applicant’s amendments.
The rejections under 35 USC 102 and 35 U.S.C. 103 are being withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 102 and U.S.C 103 are necessitated by the amendments
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 -3, 5-13 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glattstein et al. (US 20040202572 A1).
Regarding claim 1, Glattstein teaches test device comprising a housing (21 and 41 assembled together)(Figs. 2a -d, 4a and 4b and para. 0056) and a test element (reaction chamber 44) disposed within the housing, the test element comprising a sample application zone (45), an analyte detection zone (bottom 3/4 of lower part 34), and a sample flow path (top 1/4 of lower part 34)(see annotated Fig. A below), the housing comprising an analyte detection zone window (29) exposing the analyte detection zone therethrough (Fig. 4a and 4b and para. 0062), the test device further comprising a sample applicator (50) and at least one retaining member (the structure on the exterior side of 41 as shown in Fig. 2d. See also Fig. 4a) for removably retaining the sample applicator in a retained position (the position where the sample probe is retained, or kept in place, in the casing but not locked into casing. In this position, protrusion 56 of sample probe 50 is immediately above ramp 43)(para. 0062 and Fig. 5), the at least one retaining member comprising a recess (48) formed in the housing (Fig. 2d, 4a and 5), wherein an end of the sample applicator is removably retained by the recess (removably retained before the probe is pushed down to where is 56 is below 43, Fig. 5, para. 0063) and wherein
the at least one retaining member does not extend substantially beyond the housing of the test device (Fig. 4a, 4b and 5), and
wherein, in the retained position, the sample applicator does not extend substantially beyond one or more boundaries of the housing of the test device (Fig. 4a, 4b and 5; 56 of sample probe is retained on top of 43, but does not extend substantially beyond any of the housing boundaries), and wherein, in the retained position, the sample applicator at least partially obscures the analyte detection zone (annotated Figs A and B. In the retained position, tip 61 of sample applicator 50 is within the detection zone, and thus the sample applicator obscures the left side of the detection zone from the right side of the detection zone as shown in Fig. 5/annotated Fig. B. Furthermore, when looking in through window 29, the part of the analyte detection zone behind sample probe 50 is obscured by the sample probe 50 as shown in Fig. 5/annotated Fig. B. See In re Mraz, 173 USPQ 25 (CCPA 1972).
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Figure A. Annotated Fig. 2b of Glattstein.
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Figure B. Annotated Fig. 5 of Glattstein.
Regarding claim 2, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further teaches wherein the at least one retaining member (the structure on the exterior side of 41 as shown in Fig. 2d) comprises a pair of retaining members (43 and the recess immediately above 48)(para. 0062) at opposing ends of the housing (Fig. 2d).
Regarding claim 3, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further wherein the at least one retaining member further comprises:
a second recess (the recess above 43) configured to retain a second end (51) of the sample applicator (Fig. 4a).
Regarding claim 5, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further teaches wherein the housing comprises a base (27a, 28a, 59a, 49a) (Fig. 4b and para. 0064), a top surface (the surface of the casing shown in Fig. 6) and a side wall (exterior surface of 41) substantially perpendicular to the base and/or the top surface.
Regarding claim 6, (Glattstein teaches all of the elements of the current invention as stated above with respect to claim 5. Glattstein further teaches wherein the at least one retaining member (the recess of exterior side of 41 as shown in Fig. 2d) is in the side wall and/or top surface (it is in the side wall).
Regarding claim 7, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 6, wherein the at least one retaining member and the sample applicator engage by press fit (Fig. 4a and para. 0035, sample applicator can be locked in casing by press fitting).
Regarding claim 8, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. wherein the test device has a horizontal (y) axis (the axis parallel to the segment connecting from 27a to 28a), a horizontal (x) axis (the axis parallel to the segment connecting from 28a to 29a ) shorter than the horizontal (y) axis, and a vertical (z) axis and wherein the press fit is operated in the direction of the vertical (z) axis (the axis from top to bottom of the device)(Fig. 4b).
Regarding claim 9, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further wherein in the retained position, the sample applicator does not extend substantially, or at all, beyond one or more of the following:
a boundary of the device housing defined by a first plane extending in a vertical direction at a proximal end of the device located along the horizontal y axis of the device (Fig. 4a);
a boundary of the device housing defined by a second plane extending in a vertical direction at a distal end of the device located along the horizontal y axis of the device (Fig. 4a);
a boundary of the device housing defined by a third plane extending in the vertical direction at a proximal end of the device located along a horizontal x axis of the device (Fig. 4a);
a boundary of the device housing defined by a fourth plane extending in the vertical direction at a distal end of the device located along a horizontal x axis of the device (Fig. 4a);
a boundary of the device housing defined by a fifth plane extending in a horizontal direction from the uppermost point of the housing (Fig. 4a and 5, in the retaining position, 56 is above 43, but the sample probe still does not extend substantially beyond this boundary).
Regarding claim 10, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further teaches wherein the at least one retaining member comprises a projection and/or a clip (43 is a projection, Fig. 2d).
Regarding claim 11, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further teaches wherein when the test device is in a horizontal test position (the position when the test device rotate 90o to the left in Fig. 5, where in 23a is lying on a surface), and the sample applicator is in the retained position, the sample applicator is located substantially above at least one of the sample flow path, the analyte detection zone, and the sample application zone (Fig. 5, when test device is rotated to the horizontal position stated above, the sample probe is above the analyte detection zone).
Regarding claim 12, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1, Glattstein further teaches wherein
a) when the sample applicator is in a retained position, less than 50% of the volume of the sample applicator extends beyond one or more boundaries of the housing of the test device (Fig. 4a and 5, in the retaining position, 56 of the sample probe is position just above 43, the sample probe extends only beyond the top of the housing by a in substantiable amount and thus meets the limitation)(While patent drawings are not to scale, relationships clearly shown in the drawings of a reference patent cannot be disregarded in determining the patentability of claims. See In re Mraz, 173 USPQ 25 (CCPA 1972), and
b) 0% of the volume of the retaining member (the structure on the exterior side of 41 as shown in Fig. 2d) extends beyond one or more boundaries of the housing of the test device (Fig. 2d, the retaining member is within the boundaries of housing).
Regarding claim 13, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further teaches when the sample applicator is in a retained position, the sample applicator at least partially obscures the sample application (Fig. 5, and annotated Figs. A and B).
Regarding claim 23, Glattstein teaches all of the elements of the current invention as stated above with respect to claim 1. Glattstein further teaches wherein the test device comprises a sample application well (22)(“sample application” is interpreted as an intended use. 22 meets the structural limitation of the intended use) in communication with the sample application zone (45)(Fig. 2b and 2c, para. 57 and 61), and wherein when the sample applicator is in a retained position, the sample applicator at least partially obscures the sample application well and/or the analyte detection zone window (Figs. 4a and 5).
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Glattstein et al. (US 20040202572 A1) in view of Le et al. (US 20170036203 A1).
Regarding claim 22, Glattstein teaches a kit comprising a test device according to claim 3 (see above.
Glattstein teaches sampling probe 50 comprise wide body 51 (the second end) connected to removable extension 53 or 53. Glattstein teaches the removable extension can be designed according to the requirement of different test from a selection of various shapes and lengths (para. 0033 and 0063). Glattstein further teaches sample probe can be designed for collecting liquid samples e.g. syringe-like means comprising a miniature piston and a hollow edge, a spongy material edge, or any other means for collecting liquids as known in the art (para. 0033).
Glattstein does not explicitly teach that sample applicator 50 comprises a pipette, the pipette comprising a tip, a barrel, a bulb, and wherein the bulb comprises a retaining lug (See 35 U.S.C. 112a section above).
However, Le teaches a pipette for collecting liquid sample (abstract and para. 0003). Le further teaches the pipette comprises a tip (14), a barrel (16), a bulb (20), wherein the bulb comprises a retaining lug(fin 36)(Fig. 1A).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified to the removable extension (53/53a) of sampling probe 50 to a pipette comprising a tip, a barrel, a bulb, wherein the bulb comprises retaining lug (fin 36) as taught by Le in order to collect liquid sample with a reasonable expectation of success (Le, abstract and para. 0003 and Glattstein, para. 0066) (MPEP 2143)(I)(G).
The teachings of Glattstein as modified by Le would yield that sample applicator 50 comprises a pipette, the pipette comprising a tip, a barrel, a bulb, and wherein the bulb comprises a retaining lug (fin 36 which is connected to wide body 51).
Response to Arguments
Applicant’s arguments, see p. 8, filed 03/24/2026, with respect to the claim objection have been fully considered and are persuasive. The claim objection of 01/26/2026 has been withdrawn.
Applicant’s arguments, see p. 9, filed 03/24/2026, with respect to the rejection under 35 U.S.C. 112(b) have been fully considered and are persuasive. The under 35 U.S.C. 112(b) rejection of 01/26/2026 has been withdrawn in view of Applicant’s amendment of claim 22. However, upon further consideration, new grounds of rejection 35 U.S.C. under 112(a) is necessitated in view of the amendment. See the 35 U.S.C. 112(a) section above.
Applicant’s arguments, see p. 10-12, filed 03/24/2026, with respect to rejections under 35 U.S.C. 102 have been fully considered and are not persuasive.
Applicant’s argument on p. 10 relating to the “removably retaining” limitation is addressed in the Advisory Action of 04/09/2026 and shown again below for convenience
From the Advisory Action of 04/09/2026
“The Applicant also argues that Glattstein does not teach the claimed "removably retaining" limitation, which requires that the sample applicator be capable of removal from the retained position. In particular, the Applicant argues that "Even assuming arguendo that such an intermediate position exists before the probe locks into the casing, the probe cannot be "removably retained" there because the device is designed such that the probe must proceed to its irreversibly locked position for the device to be operative. " The examiner respectfully disagrees. As states in the OA of 01/26/2026, Glattstein teaches a "retaining position", and it is where protrusion 56 of sample probe 50 is immediately above ramp 43 (para. 0062 and Fig. 5), and at this position, the sample applicator/probe is removably retained. At this position, the sample probe is retained (held in place) by the casing but not irreversibly locked as Glattstein teaches that an application of force is required for the probe be locked into the casing (para. 0035), and hence the sample probe 50 can still be removed from casing at this position. This interpretation is further supported by the way the device is packaged. The device is packaged such that the sample probe is removably retained in the casing (in the retained position), and can be removed to collect sample as shown in this YouTube video, https://www.youtube.com/watch?v=21kC8tCL-os "Touch&Know® A Moment of Doubt , Happy End " posted by IDentacorp on July 21, 2015, Accessed 4/3/2026). Therefore, this argument is not persuasive.”
Applicant further argues, on pp. 10-11, “Glattstein still fails to disclose a sample applicator that at least partially obscures the analyte detection zone when in the retained position” because sampling probe 50 does not obscure the viewing window.
The examiner respectfully disagrees. It is first noted that claim 1 requires the sample applicator at least partially obscures the analyte detection zone not the viewing window. In the retained position, tip 61 of sample applicator 50 is situated within the analyte detection zone (the bottom 3/4 portion of lower part 34; see Fig. 5/annotated Fig. B), and thus the sample applicator does partially obscures, or conceal, the analyte detection zone. For example, looking in from window 29, the part of the analyte detection zone behind sample probe 50 is obscure by the sample probe 50 as shown in Fig. 5/annotated Fig. B above. Therefore, this argument is unpersuasive.
Applicant further argues that the dependent claims are allowable based on the alleged allowability of claim 1. The argument does not provide any specific supposed errors in the examiner's action, and since claim 1 is not allowable as discussed above, this argument is unpersuasive.
Applicant’s arguments, see p. 12, filed 03/24/2026, with respect to rejections of claim 22 under 35 U.S.C. 103 have been fully considered and are not persuasive.
Applicant further argues that claim 22 is allowable based on the alleged allowability of claim 1. The argument does not provide any specific supposed errors in the examiner's action, and since claim 1 is not allowable as discussed above, this argument is unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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