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 .
Response to Amendment
The Amendment filed 07/09/2026 has been entered. Claims 1-2, 6-7, 9, 12-14 and 16-20 are pending in the application and being examined herein.
Status of Objections and Rejections
All rejections of claims 3-5, 8, 10-11 and 15 are obviated by Applicant’s cancellation.
The provisional nonstatutory double patenting rejections are withdrawn in view of the terminal disclaimer.
The rejections under 35 U.S.C 112(b) are withdrawn in view of Applicant’s amendment.
The rejections of under 35 U.S.C. 102 and 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendment.
New grounds for rejection under 35 U.S.C. 103 are necessitated by Applicant’s amendments.
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.
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.
Claims 1-2, 6-7, 9, 12-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Katz et al. (US 20180339292 A1) in view of Gould et al. (US 20060292034 A1).
Regarding claim 1, Katz teaches a device (Figs. 1 -8) for testing an analyte in a liquid sample, comprising a cover body (actuating lid 2),
Katz teaches the device comprises chambers 11 and 12 with openable seal 21 and 22 at the bottom (para. 0044). Katz teaches chambers 11 and 12 are for accommodating liquids (para. 0044). Katz teaches chambers 11 and 12 locate above puncturing means 15 and 16, such that seals 21 and 22 are punctured when actuating lid 2 is actuated (para. 0047) and move downward (para. 0046, Figs. 10A and 10B) for the release of liquid within the chambers. Katz teaches chambers 11 and 12 are integrated in actuating lid 2 and not standalone chamber/containers, and thus Katz fails to teach the device comprise a liquid chamber.
However, Katz teaches in another embodiment (Fig. 9) the chambers 11 and 12 can be standalone liquid storage containers that can be removably inserted (para. 0063). In addition, Gould teaches an analyte testing device comprising a chamber for accommodating a standalone liquid storage container (Gould, buffer cup 22). Gould further teaches buffer cup 22 has rupturable bottom and is placed in a chamber above a piercing member 26, such that buffer cup 22 can be depressed downward with its bottom being pierced by piercing member 26 and consequently release the liquid being stored.
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 substituted the integrated chambers 11 and 12 with a standalone liquid storage container with rupturable bottom being removably inserted in each of chamber 11 and 12 as taught by para. 0063 of Katz and Gould (Fig. 3 and para. 0034) because it was recognized that a standalone container was an alternative to an integrated liquid chamber for liquid storage and would provide for a means for easy replacement of reagent, and simple substitution of one known element (integrated chamber) for another element (standalone liquid storage container that is to be disposed in the integrated chamber) is likely to be obvious when predictable results (providing sealed storage for liquid above a puncturable means, wherein the liquid can be released by piercing) are achieved. See MPEP 2143(I)(B).
The teachings of modified Katz yields the device comprises a liquid chamber (Katz’s standalone liquid storage container/Gould’s buffer cup 22 in chamber 12, hereinafter “Gould, buffer cup”), and the liquid chamber (Gould, buffer cup) is configured to contain a sample treatment liquid (interpreted as a functional limitation. Sample treatment liquid is not positively recited. para. 0044, buffer cup is structurally capable of containing a sample treatment liquid);
Katz teaches wherein the testing chamber (the structure of Fig. 7 and liquid receiving unit 20) has a testing element (5) therein (Fig. 7), the cover body covers an opening of the testing chamber (Fig. 2), and the sample chamber (3) and the liquid chamber (Gould, buffer cup, which is in chamber 12) are located in the testing chamber (Fig. 6A);
wherein the cover body (lid 2) comprises a docking area (the area above the top of lid 2 and within chamber 12, Fig. 2), and the locking element (6) is located in the docking area (Fig. 1), wherein when the liquid chamber (Gould, buffer cup) is located at a locking position (the position of buffer cup when lid 2 is not actuated, and buffer cup is in chamber 12 sitting above and not punctured by the puncturing means 16) relative to the cover body, the liquid chamber is hidden in the docking area and locked on the cover body by the locking element (buffer cup is hidden in chamber 12 and held in place by cover 6), and the sample treatment liquid in the liquid chamber is not released (liquid is sealed in buffer cup)(Katz, para. 0044); and when the liquid chamber is located at an unlocking position (when buffer cup is not fully inserted into chamber 12) relative to the cover body, the locking element (cover 6) departs from the docking area, the liquid chamber is exposed (buffer cup is partially outside of chamber 12), and the sample treatment liquid in the liquid chamber is capable of being released (liquid in the buffer cup can be puncture by a syringe needle and be released)(The examiner notes that this is an apparatus claim and sample treatment liquid is not positively recited. The prior art teaches structures that meet the above limitations).
Regarding claim 2, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further teaches wherein the liquid chamber (Gould, buffer cup) containing the sample treatment liquid is movable relative to the cover body (buffer cup can be removably inserted).
Regarding claim 6, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further teaches wherein the locking element comprises a limiting structure (cover) capable of limiting movement of the liquid chamber; and when the limiting structure is detached from the liquid chamber, the liquid chamber changes from a locking state (the state of buffer cup when cover 6 covers lid 2, buffer cup is not accessible from the outside) to an unlocking state (the state of buffer cup when cover 6 is removed, buffer cup from the outside).
Regarding claim 7, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 6, modified Katz further teaches wherein the liquid chamber in the unlocking state is movable relative to the cover body (when cover 6 is removed, the buffer cup can be removed from chamber 12).
Regarding claim 9, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further teaches wherein the liquid chamber (Gould, buffer cup) comprises a pierceable sealing film (Gould, pierceable material, para. 0034); and when the liquid chamber moves downward relative to the sealing film, the sealing film is pierced by a piercing element, whereby releasing the liquid in the liquid chamber (Katz, para. 0046).
Regarding claim 12, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further teaches wherein the docking area comprises a platform (the top surface of lid 2), a hole (chamber 12) is provided in the platform; and the liquid chamber (Gould, buffer cup) penetrates through the hole (chamber 12) and is located at the locking position (the positive of buffer cup when lid 2 is not actuated, and buffer cup is in chamber 12 is sitting above and not punctured by the puncturing means 16).
Modified Katz teaches the liquid chamber (Gould, buffer cup) is in chamber 12, but does not explicitly teach whether the top surface of the liquid chamber (Gould, buffer) is above, flush with or below the top opening of chamber 12, and thus modified Katz fails to teach at the liquid chamber is located at the locking position distal to the platform.
However, Gould teaches the top of the buffer cup locates below the opening of the chamber, and the cover (button 24) comprise a structure that extends into the chamber in contact with the top surface with the buffer cup (Fig. 4), such that the structure holds in place the buffer cup when a downward force is applied to pierce the bottom of buffer cup (para. 0034).
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 substituted the buffer cup and cover 6 taught by modified Katz with a buffer cup wherein its top surface locates below the opening of the chamber 12 and a cover with a structure that extends into chamber 12 and in contact with the top surface of the buffer cup as taught by Gould (Fig. 4) because it was recognized that the buffer cup wherein its top locates below the opening of the chamber 12 and the cover with a structure that extends into chamber 12 and in contact with the top surface of the buffer cup was an alternative to the buffer cup of Gould and cover 6 of Katz and would provide accommodation for a buffer cup that is lower in height than of chamber 12 to be used in the device, and simple substitution of one known element (the buffer cup wherein its top locates below the opening of the chamber 12 and cover with a structure that extends into chamber 12) for another element (buffer cup of Gould and cover 6 of Katz) is likely to be obvious when predictable results (a standalone container being pierced when a downward force is applied to it) are achieved. See MPEP 2143(I)(B).
The teachings of modified Katz would yield the liquid chamber is located at the locking position distal to the platform (below the opening of chamber 12), and the liquid chamber at the locking position distal to the platform is locked by the locking element (buffer cup in is in chamber 12 hold in place by modified cover 6).
Regarding claim 13, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 12. Modified Katz further wherein when the locking element (cover 6) is away from or detached from the docking area, the liquid chamber is capable of moving from the locking position distal to the platform the unlocking position (the buffer cup is not fully inserted in chamber 12) proximal to the platform (closer to the platform).
Regarding claim 14, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Katz further teaches wherein a channel (the channel in 3 that connects to 14, Fig. 6A) is provided in the sample chamber; when the sample collector is inserted into the channel of the sample chamber, an absorption element of the sample collector is squeezed (interpreted as an intended use. The sample collector is not positively recited. The channel meets the structural limitation of the intended use), whereby releasing the liquid sample into the sample chamber; and then the liquid flows out of the sample chamber along the channel (interpreted as an intended use. the channel meets the structural limitation of the intended use)(Fig. 6A).
Regarding claim 16, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further teaches wherein the sample chamber (3) and the liquid chamber (Gould, buffer cup, which is in chamber 12) extend outward from the cover body (2) in a same direction (Fig. 6A).
Regarding claim 17, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further teaches wherein the testing chamber comprises a piercing element (16) capable of piercing the liquid chamber (Katz, Figs. 2, 3, 10A and 10B, paras. 46-49; Gould, Fig. 4).
Modified Katz teaches the buffer cup (liquid chamber) is disposed in the chamber 12 of actuating lid 2 (cover body), and cover 6 covers the top surface of actuating lid 2 where the opening of chamber 12 (Figs. 1 and 2). Modified Katz teaches the liquid chamber (buffer cup) moves downward together with the cover body (lid 2) for the liquid chamber to be pierced (Katz, para. 0046), and thus fails to teach when the liquid chamber moves inward the testing chamber relative to the cover body, the piercing element pierces the liquid chamber and enters therein, such that the liquid in the liquid chamber is forced to flow into the testing chamber (Katz, Figs. 2, 3, 10A and 10B, paras. 46-49; Gould, Fig. 4).
However, Gould teaches an analyte testing device as discussed above (claim 1). Gould teaches buffer cup 22 (liquid chamber) is disposed in cylinder 20 of upper portion 17 (cover body), and cover 13 covers the opening of cylinder 20 (Figs. 1 and 2, para. 0034). Gould teaches cover 13 comprises a hole where button 24 fits (Fig. 1), and button 24 is used to actuate the downward movement of the buffer cup for the buffer cup to be pierced (para. 0034).
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 cover 6 taught by Katz with a hole and a depressible button that fit in the hole for chamber 12 as taught by Gound (Figs. 1 and 4) because such a modification would allow chamber 12 to be actuated individually, and the claimed limitation are obvious because all the claimed elements (a cover and a cover with a hole that fits depressible button) were known in the prior art and a POSITA could have combined the elements as claimed by known methods with no change in their respective functions and the combination yielded nothing more than predicable results (actuating a downward force for the piercing of buffer cup). See MPEP 2143 (I)(A).
The teachings of modified Katz would yield when the liquid chamber moves inward the testing chamber relative to the cover body (Gould, buffer cup being depressed by the button), the piercing element pierces the liquid chamber and enters therein, such that the liquid in the liquid chamber is forced to flow into the testing chamber (Katz, Figs. 2, 3, 10A and 10B, paras. 46-49; Gould, Fig. 4).
Regarding claim 18, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 17. Modified Katz teach the piercing element (opening means 16) is provided with a sharp piercing needle (para. 0047, opening means 16 form a sharp point) and a base connected with the piercing needle (Figs. 4-5)
Modified Katz does not explicitly teach a diameter of the base is equivalent to that of the liquid chamber.
However, Gould teaches an analyte testing device as discussed above. Gould further teaches the device comprises piercing member 26 for rupturing buffer cup 22 (liquid chamber) when a downward force is applied to buffer cup 22. Gould teaches piercing member 26 is provided with a sharp piercing needle (Fig. 4) and a base (29) connected with the piercing needle (Fig. 4). Gould further teaches a diameter of the base is equivalent to that of the liquid chamber (Fig. 4).
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 the base of 16 taught by Katz with the base with a diameter of the base is equivalent to that of the liquid chamber taught by Gould because was recognized that base 29 of taught was an alternative to the base of 16 (Fig. 4) and would provide a base for opening means 16, and simple substitution of one known element (base of 16, Fig. 4 of Katz) for another element (base 29 of Gould) is likely to be obvious when predictable results (a base for a piercing element) are achieved. See MPEP 2143(I)(B). Furthermore, it has been held that a mere change in shape or size without affecting the functioning of the part been within the level of a POSITA (MPEP 2144.04 (IV, A and B)). A POSTIA would have been motivated to select the shape and size of base taught by Gould for the purpose of ease of manufacturing.
Regarding claim 19, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Katz further wherein the testing chamber (the structure of Fig. 7 and liquid receiving unit 20) comprises a carrier (the structure that holds the end of 5 at the right) for carrying the testing element (assay means 5), and the carrier is provided with a groove (the structure has groove where the right end of 5 is disposed) for fixing the testing element (Fig. 7).
Regarding claim 20, modified Katz teaches all of the elements of the current invention as stated above with respect to claim 19. Modified Katz teaches wherein a hole (the top opening of chamber 11) communicating with atmosphere is provided in the cover body, and a channel (chamber 11) extending towards the testing chamber is provided in the hole.
Response to Arguments
Applicant’s arguments, see pp. 5-6, filed 7/9/2026, with respect to the provisional non statutory double patenting rejections have been fully considered and are persuasive. The provisional rejections of 04/09/2026 have been withdrawn.
Applicant’s arguments, see p. 6, filed 7/9/2026, with respect to the rejection under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections of 04/09/2026 have been withdrawn.
Applicant’s arguments, see pp. 6-9, filed 7/9/2026, with respect to the rejections under 35 U.S.C. 102 and 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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