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 4/1/26 is acknowledged. Claims 7, 10-11, 13 and 17 were canceled. Claims 1-6, 8-9, 12, 14-16 and 18-21 are pending and are under examination.
Response to Reply
Drawings
In light of applicant’s claim amendments, the prior drawing objection is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-9, 12, 14-16 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 1, the claim language, “the length of the second dimension” does not appear to be supported by the originally filed disclosure because the length direction is associated with the longitudinal direction, as described in e.g., [0045] of Applicant’s PG Pub., which recites, “when the test strip in the manner of lateral flow is used, the length direction of said test strip is defined as the longitudinal direction, i.e., the direction of liquid flowing on the test strip from the sample addition pad to the water absorbing pad is the longitudinal direction, and the direction perpendicular to the liquid flow direction is the transverse direction.”
For claim 14, the claim language, “test element” in the preamble does not appear to be supported by the originally filed disclosure. Because a “test element” is known in the art to refer to a test strip, the test cassette, positioning column and the structural elements associated with the positioning column appear to be beyond the scope of the claimed invention.
In light of applicant’s claim amendments, the prior rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn, except for the following below, and new rejections follow.
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, 8-9, 12, 15-16 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 length of the second dimension". There is insufficient antecedent basis for “the length” limitation in the claim. What is the length of the second dimension referring to? The longitudinal axis or the transverse axis?
Claims 3 and 16 are rejected because “the shape” raises an antecedent basis issue.
Claim 5 is rejected because “the longitudinal central axis” raises an antecedent basis issue.
The prior rejection of claim 9 is maintained because “at least two of the transverse limiting columns” raises an antecedent basis issue. The Office recommends amending the rejected claim language to “at least two transverse limiting columns”.
Claims 15, 16, 18 and 19 is rejected because “The test strip” raises an antecedent basis issue.
Claim 20 is rejected because “the longitudinal central axis” raises an antecedent basis issue.
Claim 21 is rejected because “the longitudinal central axis” raises an antecedent basis issue.
Claim Interpretation
The Office asserts that terms and phrases like “configured and adapted to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured and adapted 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 Rejection
In light of applicant’s claim amendments, the prior art rejection is modified.
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, 8-9, 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, previously cited) in view of LIU HAI et al. (“LIU,” CN 210690594 U, cited in IDS, English translation was used for rejection below, previously cited).
As to claims 1, 2, 15, 20 and 21, YUE discloses a detection device, comprising: a test cassette (card body) comprising an upper cover (4 or 5) and a bottom plate (4 or 5); a test strip (test paper) mounted between the upper cover and the bottom plate (fig. 3), wherein the test strip comprises a first dimension along a longitudinal axis (fig. 3) and a second dimension along a transverse axis, wherein the first dimension is greater than the length of the second dimension and a positioning hole (6 or 7 in figs. 3-4) extending through the test strip (test paper), wherein the test cassette comprises a positioning column 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 configured and adapted to provide a clamping fit along the longitudinal axis of the test strip, and a loose fit along the transverse axis of the test strip. 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 configured and adapted to provide a clamping fit along the longitudinal axis of the test strip, and a loose fit along the transverse axis of the test strip because it would provide structural stability of the test strip inside the test cassette and thus, enhance the degree of accuracy of detection (see after drawing descriptions of YUE, and abstract of LIU).
As to claims 3, 4 and 16, the combination of YUE and LIU disclose 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 on 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 8-9, the combination of YUE and LIU disclose the test cassette further comprises at least two transverse limiting columns, said at least two transverse limiting columns being located on two sides of the longitudinal central axis of the test cassette and configured and adapted to position the test strip between the at least two transverse limiting columns (see 5 or 8 in figs. 1-4 of YUE). See motivation statement above.
As to claims 12, 14, 18 and 19, YUE discloses a test element comprising: a test cassette (card body) comprising an upper cover (4 or 5) and a bottom plate (4 or 5); a test strip (test paper) mounted between the upper cover and the bottom plate (fig. 3), wherein the test strip comprises a first dimension along a longitudinal axis (fig. 3) and a second dimension along a transverse axis, wherein the first dimension is greater than the length of the second dimension and a positioning hole (6 or 7 in figs. 3-4) extending through the test strip (test paper), wherein the test cassette comprises a positioning column inserted into the positioning hole (6 or 7). YUE further discloses 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 is disposed in the water absorbing pad (fig. 3 of YUE).
Regarding claims 12, 14, 18 and 19, YUE does not specifically disclose the positioning hole and the positioning column are configured and adapted to provide a clamping fit along the longitudinal axis of the test strip, and a loose fit along the transverse axis of the test strip. 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 configured and adapted to provide a clamping fit along the longitudinal axis of the test strip, and a loose fit along the transverse axis of the test strip because it would provide structural stability of the test strip inside the test cassette and thus, enhance the degree of accuracy of detection (see after drawing descriptions of YUE, and abstract of LIU).
Response to Arguments
Applicant's arguments filed 4/1/26 have been fully considered but they are not persuasive.
In response to applicant's argument on p. 7-9 of the reply that the locking structure of LIU has nothing to do with mating a test strip to a card holder in the manner of the primary YUE reference, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, in response to applicant's argument that on p. 7-9 of the reply regarding the locking structure of LIU, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the intended use claim language is “configured and adapted to provide a clamping fit along the longitudinal axis of the test strip, and a loose fit along the transverse axis of the test strip”. Because the combination of YUE and LIU disclose the positively claimed structural limitations, which are capable of providing a clamping fit along the longitudinal axis of the test strip, and a loose fit along the transverse axis of the test strip, then the combination of YUE and LIU properly read on the rejected claim language.
In response to applicant's argument on p. 7-9 of the reply regarding the locking structure of LIU, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here, even though Applicant and the combination of YUE and LIU use the same structural arrangement for different purposes, this difference does not make the claimed invention patentable.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
6/12/2026
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