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 .
Status of Claims
Applicant’s reply filed 8/5/25 is acknowledged. Claims 13-19 were added. Claims 1-19 are pending and are under examination.
Response to Reply
Claim Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
Prior Art Rejections
In light of applicant’s claim amendments, the prior art rejection is modified, and a new rejection follows.
Claim Rejections - 35 USC § 102
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 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.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chatelier et al. (“Chatelier,” US Pub. No. 2011/0155585, previously cited).
As to claim 1, Chatelier discloses a test strip in e.g., [0077] et seq., comprising: a main body portion defining a flow path (e.g., detection chamber 120); a reagent portion (e.g., liquid reagents 130, 132, [0089] et seq.) located in the flow path; and an intake portion (e.g., fill chamber 122) located at a starting end of the flow path and configured to allow introduction of a sample into the flow path; wherein: the main body portion comprises: a buffer space (e.g., air hole 124) communicating with a terminal end of the flow path, and a vent hole (e.g., [0009] et seq.) opened at an outer surface of the main body portion and communicating with the buffer space; the vent hole being uncovered and open directly to a space outside the test strip ([0102] vent hole is uncovered and open directly to a space outside the test strip when “piercing instrument can be configured to pierce at least one of the first and second sealing components at a desired time so that air can flow out of the vent hole and liquid can flow from the reaction chamber into the detection chamber”) and in a region where the buffer space and the flow path are connected, a cross-sectional area of the buffer space is larger than a cross-sectional area of the flow path (e.g., [0089] et seq., and fig. 6).
With regard to claim 1, in an alternative embodiment(s), vent hole is uncovered and open directly to a space outside the test strip in figs. 4A-5D, As disclosed in e.g., [0082], “where two openings 70 are present one can act as a sample receiving port for delivery of a fluid sample while the other can act as a vent. One skilled in the art will appreciate that sample can be delivered to sample reaction chamber 61 using alternative structures including sample receiving ports and/or vents positioned at different locations in test strip body 59, such as, for example, sample receiving ports and/or vents positioned in first and/or second electrically conductive layers 66, 64.” It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have a vent hole being uncovered and open directly to a space outside the test strip because the sample can be delivered to sample reaction chamber using alternative structures including vents positioned at different locations in test strip body (e.g., [0082] of Chatelier).
As to claim 2, see fig. 4A-6.
As to claim 3, see fig. 6 and [0089] et seq.
As to claims 4-6, see e.g., [0074] et seq.
As to claims 7-9, for the maximum displacement amounts, see e.g., [0073] et seq. Alternatively, it would appear that such dimensions are result-effective variables. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to determine, through routine experimentation, the claimed dimensions because discovering the optimum or workable ranges involves only routine skill in the art.
Claims 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chatelier in view of Cai et al. (“Cai,” US Pub. No. 2015/0233861, newly cited).
As to claims 13-16, while Chatelier discloses a vent hole connected to a buffer space in figs. 4A-6, Chatelier does not specifically disclose the vent hole is smaller than a cross-sectional area of the buffer space. Cai discloses in figs. 1a-10d and [0022] et seq., a second upper layer 500 has several small openings 74 (“vent holes”) at the sampling end 20, and in [0039] et seq., electrode cutouts 31, 32, 33 may comprise a mixture of a polymer, an enzyme, a surfactant, an electron acceptor, an electron donor, a buffer, a stabilizer and a binder. As shown in fig. 3, for example, vent holes (74) are smaller than a cross-sectional area of the buffer space (31, 32 or 33). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, for the vent hole to be smaller than a cross-sectional area of the buffer space because having multiple small vent openings instead of a large vent opening can effectively eliminate over-flow issues often encountered in conventional sensors (e.g., [0031] of Cai).
As to claims 10-12 and 17-19, while Chatelier discloses an end of the reagent portion on a buffer space side and an end of the buffer space on a flow path side in the arrangement direction of the flow path and the buffer space in figs. 4A-6 and [0073] et seq., Chatelier does not specifically disclose a maximum displacement amount is less than 0.24 mm, or is in the range of 0.02 mm to 0.26 mm. Cai discloses dimensions of the test sensor in e.g., [0025] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have a particular maximum displacement range because such dimensions are result-effective variables, and it would be beneficial to determine, through routine experimentation, the claimed dimensions because discovering the optimum or workable ranges involves only routine skill in the art.
Response to Arguments
Applicant's arguments filed 8/5/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments on p. 6-7 of the reply, the Office respectfully disagrees. As explained above, Chatelier’s vent hole is uncovered and open directly to a space outside the test strip because Chatelier discloses in e.g., [0102], “piercing instrument can be configured to pierce at least one of the first and second sealing components at a desired time so that air can flow out of the vent hole and liquid can flow from the reaction chamber into the detection chamber”. In addition, Chatelier discloses in e.g., [0082], “where two openings 70 are present one can act as a sample receiving port for delivery of a fluid sample while the other can act as a vent. One skilled in the art will appreciate that sample can be delivered to sample reaction chamber 61 using alternative structures including sample receiving ports and/or vents positioned at different locations in test strip body 59, such as, for example, sample receiving ports and/or vents positioned in first and/or second electrically conductive layers 66, 64.” Thus, Chatelier properly discloses a vent hole being uncovered and open directly to a space outside the test strip.
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 LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
11/15/2025