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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 05/27/2026 is acknowledged. The traversal is on the ground(s) that claims 1-21 should be examined on the merits. The claims identified under Group II ultimately depend from claim 1. This is not found persuasive because Inventions I and II as claimed have materially different designs. For example, claim 20 requires the test device of claim 5, whereas claim 1 does not. As noted in the 03/27/2026 Requirement for Restriction, there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; and (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of Species A. 3. Figs. 6-7; and Species B. 3. Fig. 11 in the reply filed on 05/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-19 are being examined.
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 1-19 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 housing" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the outer end" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the cartridge" in L2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the phrase “if present” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 15, the phrase “if present” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claims 3-5, 7, 8, 16, 17, 19 the wherein clause renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 8 and 10-19 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Katz et al. (US 2018/0339292 A1).
Regarding claim 1, Katz et al. teach:
1. A test device (e.g., assay device 1) comprising:
a receiving area (e.g., 60) for receiving a sample collection stick (e.g., 17; see Figs. 6A, 6B for example);
a liquid reservoir forming a separated area within a housing and filled with a reaction solution (see Claim 1 a, b for example); and
an analysis area integrated into the housing (see Claim 1 d for example).
Regarding claim 1, Katz et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “for carrying out a test directed to the detection of an organic structure, with a housing”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claims 1, 9, 10, 11, 16, 17, 18, 19 (e.g., [...] for receiving a sample collection stick; [...] for stripping the sample collection stick; [...] for analyzing a sample solution; [...] for reading a test result of the analysis element, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 2, 3, 7, 8, 10-19, Katz et al. teach:
2. The test device according to claim 1, wherein the housing is configured as a one-piece component (see Figs. 3-6 for example).
3. The test device according to claim 1, wherein an extraction area (e.g., 14) is further provided in the housing (see Fig. 6A for example).
7. The test device according to claim 2, wherein an extraction area (e.g., 14) is provided (see Fig. 6A for example).
8. The test device according to claim 2, wherein an extraction area (e.g., 14) is tapered in a funnel shape (see Fig. 6A for example).
10. The test device according to claim 1, wherein the analysis area comprises: an analysis element (e.g., 5); and a window (e.g., 10) for reading a test result of the analysis element (see ¶ 0059-0060 for example).
11. The test device of claim 10, wherein the analysis element is a test strip (e.g., 5) according to the lateral flow principle (see ¶ 0059 for example).
12. The test device of claim 10, wherein the analysis element is an electronic or chip-based analysis element (a chip based is sufficiently broad to have read on the assay means 5).
13. The test device according to claim 1, wherein the receiving area, the fluid reservoir, the analysis area are arranged one behind the other in a longitudinal direction of the housing (see Figs. 1-6A for example).
14. The test device according to claim 1, wherein the housing comprises a laterally outwardly projecting area in which the analysis element is received (see Fig. 1 for example).
15. The test device according to claim 14, wherein the analysis element is connected via an area adjacent to a separation layer of the fluid reservoir (see Fig. 6A & Claim 1 d for example).
16. The test device according to claim 1, wherein a cover (e.g., 2) is provided on an opening of the housing, which cover is movable on the housing by means of a two-stage or multi-stage locking mechanism (see ¶ 0053 & Figs. 10A-10B for example).
17. The test device according to claim 1, wherein a cover (e.g., 2) is provided on an opening of the housing, which cover is movable on the housing by means of a two-stage click mechanism or by means of a two-stage screw mechanism or by means of a two-stage combined click-screw or screw-click mechanism (see ¶ 0053 & Figs. 10A-10B for example).
18. The test device according to claim 16, wherein the sample collection stick is capable of being retained in the housing and secured by the cover (see ¶ 0052, 0054 & Figs. 6A-6B for example).
19. The test device according to claim 16, wherein the sample collection stick is movable by movement of the cover into the housing against a first separation layer of the liquid reservoir for opening thereof (see ¶ 0052, 0054 for example).
Claim(s) 1-4, 7, 8 and 10-19 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Bernstein (US 4,770,853).
Regarding claim 1, Bernstein teaches:
1. A test device (Abstract+) comprising:
a receiving area (e.g., 13) for receiving a sample collection stick (e.g., 2; see Fig. 1 for example);
a liquid reservoir (e.g., 15, 20) forming a separated area within a housing and filled with a reaction solution (e.g., reagents; see Claim 1 d, e & Fig. 1 for example); and
an analysis area (e.g., 10) integrated into the housing (see Claim 1 g-i & Fig. 1 for example).
Regarding claim 1, Bernstein meets all the structural limitations recited by the instant invention. Applicants’ preamble recites “for carrying out a test directed to the detection of an organic structure, with a housing”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claims 1, 9, 10, 11, 16, 17, 18, 19 (e.g., [...] for receiving a sample collection stick; [...] for stripping the sample collection stick; [...] for analyzing a sample solution; [...] for reading a test result of the analysis element, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 2-4, 7, 8, 10-19, Bernstein teaches:
2. The test device according to claim 1, wherein the housing is configured as a one-piece component (see Fig. 1 for example).
3. The test device according to claim 1, wherein an extraction area is further provided in the housing (see Claim 8 for example).
4. The test device according to claim 1, wherein a plurality of liquid reservoirs (e.g., 15, 20) is provided in the housing with reaction solutions received therein (see Fig. 1 for example), each of which is delimited from one another and from the outside by separation layers (see Claim 1 c-e & Fig. 4 for example).
7. The test device according to claim 2, wherein an extraction area is provided (see Claim 8 for example).
8. The test device according to claim 2, wherein an extraction area is tapered in a funnel shape (see Fig. 5 for example).
10. The test device according to claim 1, wherein the analysis area comprises: an analysis element (Claim 1 g); and a window (e.g., 11) for reading a test result of the analysis element.
11. The test device of claim 10, wherein the analysis element is a test strip (see Fig. 6 for example).
12. The test device of claim 10, wherein the analysis element is an electronic or chip-based analysis element (a chip based is sufficiently broad to have read on small elements shown in Fig. 6).
13. The test device according to claim 1, wherein the receiving area, the fluid reservoir, the analysis area are arranged one behind the other in a longitudinal direction of the housing (see Fig. 1 for example).
14. The test device according to claim 1, wherein the housing comprises a laterally outwardly projecting area in which the analysis element is received (see Fig. 1 for example).
15. The test device according to claim 14, wherein the analysis element is connected via an area adjacent to a separation layer of the fluid reservoir (see Fig. 1 for example).
16. The test device according to claim 1, wherein a cover (e.g., 14) is provided on an opening of the housing, which cover is movable on the housing by means of a two-stage or multi-stage locking mechanism (see C4/L40-46 for example).
17. The test device according to claim 1, wherein a cover (e.g., 14) is provided on an opening of the housing, which cover is movable on the housing by means of a two-stage click mechanism or by means of a two-stage screw mechanism or by means of a two-stage combined click-screw or screw-click mechanism (see C4/L40-46 for example).
18. The test device according to claim 16, wherein the sample collection stick is retained in the housing and secured by the cover (see Fig. 1 for example).
19. The test device according to claim 16, wherein the sample collection stick is movable by movement of the cover into the housing against a first separation layer of the liquid reservoir for opening thereof, and is movable against any further separation layer for release of the liquid from the liquid reservoir or a further liquid reservoir towards the analysis area (see C4/L40-59+ for example).
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(s) 5, 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein (US 4,770,853).
Regarding claim 5, Bernstein teaches: 5. The test device according to claim 1, wherein a cartridge containing at least one liquid reservoir is received in the housing (see Figs. 3-4 for example), wherein each liquid reservoir is delimited by seals (e.g., 7). Bernstein further teaches the use of membranes, see Claim 1 g. However, Bernstein does not explicitly teach wherein each liquid reservoir is delimited by membranes.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the seals with membranes, so that membranes may be coated with antigen or antibody or other complementary ligands or receptors and can be used to determine the presence of different antigens or antibodies (C5/L40-44).
Regarding claims 6 & 9, modified Bernstein teaches:
6. The test device according to claim 5, in which the cartridge is fixed in the housing by means of a clamp or click connection (see C4/L40-46 for example).
9. The test device according to claim 5, wherein the cartridge comprises a stripping element capable of stripping the sample collection stick (see side wall in Figs. 1, 5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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