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 .
Applicant’s filing of claims 1-6, 8-10, 12, 14-16 and 18-21 on 12/1/23 is acknowledged. Claims 7, 11, 13 and 17 were canceled. Claims 1-6, 8-10, 12, 14-16 and 18-21 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/11/24 was acknowledged. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the test pad (claim 14) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-6, 8-10, 12, 14-16 and 18-21 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 the limitation "the positioning hole". There is insufficient antecedent basis for this limitation in the claim. Also, the structural relationship of the positioning hole and the detection device is unclear.
Claims 8 and 9 are rejected because “said two transverse limiting columns” raises an antecedent basis issue. The Office recommends amending to “said at least two transverse limiting columns”.
Claims 9 and 10 are rejected because each claim depends on canceled claim 7. For examination purposes, the Office will interpret claims 9 and 10 to depend on claim
Claim 10 is rejected because “the transverse limiting columns” raises an antecedent basis issue. The Office recommends amending to “said at least two transverse limiting columns”.
Claims 12 and 19 are rejected because “the positioning hole passes through the water absorbing pad” is unclear. The Office recommends amending “passes through” to “the positioning hole is disposed in the water absorbing pad”.
Claim 14 is rejected because the scope of the preamble is unclear. To clearly define the scope of the preamble, the Office recommends including a colon after “comprising”.
Claim 14 is rejected because it claims a process, e.g., “used to” in a test strip claim, which is an apparatus-type of claim. Thus, it is unclear how the “used to” step structurally further defines the claimed system. For examination purposes, the claim language will be given the appropriate weight and interpreted as functional claim language.
Claims 14 and 15 are rejected because it is unclear whether the positioning column and the structural elements associated with the positioning column are being positively claimed. In light of applicant’s specification, because the claimed invention is directed to the test strip, the positioning column and the structural elements associated with the positioning column are beyond the scope of the claimed invention. Thus, the positioning column and the structural elements associated with the positioning column will be considered intended use and/or functional claim language.
Claim 18 is rejected because “a supporting pad” raises an antecedent basis issue. Because claim 14 already claims “a supporting pad”, it is unclear whether this is referring to another supporting pad.
Claim Interpretation
The Office asserts that 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.
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.
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 1-6, 8-10, 12, 14-16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over YUE TAO (“YUE,” CN 207352021 U, cited in IDS, English translation was used for rejection below) in view of LIU HAI et al. (“LIU,” CN 210690594 U, cited in IDS, English translation was used for rejection below).
As to claims 1, 2, 15, 20 and 21, YUE discloses a detection device, comprising a test cassette (card body) and test strip (test paper), the test cassette comprising an upper cover (4 or 5) and a bottom plate (4 or 5), the test strip being mounted between the upper cover and the bottom plate (fig. 3), a positioning column (6 or 7) being disposed in the test cassette, said positioning column being inserted into the positioning hole (6 or 7).
Regarding claims 1, 2, 15, 20 and 21, YUE does not specifically disclose the positioning hole and the positioning column are in clamping fit in the longitudinal direction, and the positioning hole and the positioning column are in loose fit in the transverse direction. LIU discloses in in figs. 1-6 and claim 4, a locking structure comprises a boss (42) is integrally formed on the lower end face of the bracket (4), the lower end of the boss (42) is integrally formed with a clamping table (43) with an outer diameter larger than the boss (42), a through hole (23), which can be passed by the clamping table (43) is arranged in the sliding table (2), a clamping hole (24) communicated with the through hole (23) is arranged in the sliding table (2) on the left side of the through hole (23), and after the boss (42) slides into the clamping hole (24), the upper end face of the sliding table (2). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the positioning hole and the positioning column in a clamping fit in the longitudinal direction, and the positioning hole and the positioning column in a loose fit in the transverse direction because it would enhance the degree of accuracy of detection (abstract of LIU).
As to claims 3, 4 and 16, the shape of the positioning column is round, and the shape of the positioning hole is oval (figs. 1-4 of YUE).
As to claims 5 and 6, the combination of YUE and LIU disclose the positioning column is located on the longitudinal axis of the test cassette, and the center point of said positioning hole is located near by the central axis of the test strip (figs. 1-4 of YUE and figs. 1-6 of LIU). See motivation statement above.
As to claims 8-10, YUE discloses the test cassette further comprises at least two transverse limiting columns, said two transverse limiting columns being located on two sides of the longitudinal central axis of the test cassette (see 5 or 8 in figs. 1-4 of YUE).
As to claims 12, 14, 18 and 19, the combination of YUE and LIU disclose the test strip (test paper of YUE) comprises a supporting pad (11 of YUE), and a sample addition pad (or test pad, 10 of YUE), a label pad (12 of YUE), a detection pad (13 of YUE) and a water absorbing pad (14 of YUE) which are placed on the supporting pad in a manner of being superimposed on each other in sequence from upstream to downstream (fig. 3 of YUE), wherein the positioning hole passes through the water absorbing pad (fig. 3 of YUE), wherein the positioning hole is used to accommodate a positioning column (fig. 3 of YUE), the positioning hole and the positioning column are in clamping fit in the longitudinal direction, and the positioning hole and the positioning column are in loose fit in the transverse direction (see figs. 1-6 and claim 4 of LIU). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the positioning hole and the positioning column in a clamping fit in the longitudinal direction, and the positioning hole and the positioning column in a loose fit in the transverse direction because it would enhance the degree of accuracy of detection (abstract of LIU).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
11/15/2025