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 .
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.
(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.
1. Claims 1, 2 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2019/0153552 to Walther-Antonio et al. (cited by applicant).
Walther-Antonio et al. discloses an elongate support (a glass vial, [0007]) comprising a first surface (a first interior surface, [0007]), a first nucleic acid reversibly attached on the first surface (a first nucleic acid reversibly attached to a first interior surface, Para. (0007)), and a second nucleic acid immobilized to the first surface or to a second surface (a second nucleic acid immobilized to a second interior surface, [0007]), wherein the first surface is silanized (silanized clear glass vials, [0042]), wherein the first nucleic acid is complementary to a first segment of a selected nucleic acid marker, and wherein the second nucleic acid is complementary to a second segment of the selected nucleic acid marker (wherein the first nucleic acid is complementary to a first nucleic acid sequence of a selected marker, and wherein the second nucleic acid is complementary to a second nucleic acid sequence of the marker, (0007]).
I.) Regarding applicant’s claim 1, as noted above, Walther-Antonio et al. teaches all the elements of claim 1.
Therefore, Walther-Antonio et al. anticipates claim 1.
II.) Regarding applicant’s claim 2, as noted above Walther-Antonio et al. anticipates claim 1 from which claim 2 depends.
Claim 2 recites that the elongate support comprises glass.
As noted above, Walther-Antonio et al. teaches an elongate support that is a glass vial.
Therefore, Walther-Antonio et al. anticipates claim 2.
III.) Regarding applicant’s claim 9, as noted above Walther-Antonio et al. anticipates claim 1 from which claim 9 depends.
Claim 9 recites that the marker is from one or more high-risk human papillomavirus (HPV) strains or from an infectious agent.
Walther-Antonio et al. teaches that the marker can be from one or more high-risk human papillomavirus (HPV) strains (e.g., one or more of HPV 16, HPV 18, HPV 31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 56, HPV 58, HPV 59, and HPV 68). [0007]
Therefore, Walther-Antonio et al. anticipates claim 9.
7. Claims 17 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walther-Antonio et al.
Walther-Antonio et al. discloses an elongate support (a glass vial, [0007]) comprising a silanized surface with a nucleic acid immobilized thereon (a first nucleic acid reversibly attached to a first interior surface and a second nucleic acid immobilized on a second interior surface, [0007]; silanized clear glass vials, [0042]), wherein the nucleic acid is complementary to a first segment of a selected nucleic acid marker (wherein the first nucleic acid is complementary to a first nucleic acid sequence of a
selected marker, and wherein the second nucleic acid is complementary to a second nucleic acid sequence of the marker, [0007)).
I.) Regarding applicant’s claim 17, as noted above, Walther-Antonio et al. teaches all the elements of claim 17.
Therefore, Walther-Antonio et al. anticipates claim 17.
II.) Regarding applicant’s claim 22, as noted above Walther-Antonio et al. anticipates claim 17 from which claim 22 depends.
Claim 22 recites that the marker is from one or more high-risk human papillomavirus (HPV) strains or from an infectious agent.
As noted above, Walther-Antonio et al. teaches that the marker can be from one or more high-risk human papillomavirus (HPV) strains (e.g., one or more of HPV 16, HPV 18, HPV 31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 56, HPV 58, HPV 59, and HPV 68). [0007]
Therefore, Walther-Antonio et al. anticipates claim 22.
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.
2. Claim 7 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al.
I.) Regarding applicant’s claim 7, as noted above, Walther-Antonio et al. anticipates claim 1 from which claim 15 depends.
Claim 7 recites that the second nucleic acid is coupled to a means for visual detection.
Walther-Antonio et al. teaches that the first nucleic acid complementary to a nucleic acid sequence of the marker is labeled with a means for visual detection, and where the second nucleic acid is complementary to a second nucleic acid sequence of the marker and that HRP is the means for visual detection. [0009]
It would have been obvious to modify Walther-Antonio et al. and couple the second nucleic with a means for visual detection for detecting the same.
Alternatively, the terms “first” and “second” in relationship to the nucleic acids can be interchanged.
Therefore, Walther-Antonio et al. renders claim 7 obvious.
3. Claim 4 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 1 and further in view of U.S. Patent Application Publication No. 2004/0209267 to Beyer et al.
I.) Regarding applicant’s claim 4, as noted above, over Walther-Antonio et al. anticipates claim 1 from which claim 4 depends.
Claim 4 recites that the elongated support is a glass capillary tube.
Walther-Antonio et al. does not teach that the elongated support is a glass capillary tube.
Beyer et al. teaches binding of nucleic acids to support materials and that capillary tubes can be used as functionalized supports. [0035]
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to conduct HPV screening using a capillary tube as a supporting structure as taught by Beyer et al. and include the first and second nucleic acids on or in the capillary tube for contacting the same with a test fluid for screening.
Therefore, Walther-Antonio et al. in view of Beyer et al. renders claim 4 obvious.
4. Claim 5 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 1 and further in view of U.S. Patent Application Publication No. 2019/0242030 to Jackson et al.
I.) Regarding applicant’s claim 5, as noted above, Walther-Antonio et al. anticipates claim 1 from which claim 5 depends.
Claim 5 recites that the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling, and wherein the second nucleic acid is dry-stored on the first surface or the second surface.
Walther-Antonio et al. teaches dry-stored nucleic acids ([0007]) but does not teach that the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling.
Jackson et al. teaches streptavidin-biotin coupling of functional ligands or indicator molecules to substrates. [[0058], [0071]
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to have the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling, in view of Jackson et al. teaching biotin-streptavidin coupling, and have the second nucleic acid dry-stored on the first surface or the second surface.
Alternatively, the terms “first” and “second” in relationship to the nucleic acids can be interchanged.
Therefore, Walther-Antonio et al. in view of Jackson et al. renders claim 5 obvious.
5. Claim 15 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 1 and further in view of U.S. Patent No. 5,800,992 to Fodor et al.
I.) Regarding applicant’s claim 15, as noted above, Walther-Antonio et al. anticipates claim 1 from which claim 15 depends.
Claim 15 recites that the silanized first surface comprises functional groups derived from (3- aminopropyl)triethoxysilane (APTES), N-(2-amionethyl)-3-aminopropyltriethoxysilane (AEAPTES), N-(2-aminoethyl)-3-aminopropyltrimethoxysilane (AEAPTMS), or N-(6- aminohexyl)amionmethyltriethoxysilane (AHAMTES).
Walther-Antonio et al. does not teach how the surface is silanized.
Fodor et al. teaches the use of aminopropyltriethoxysilane to allow silane compounds to polymerize on substrate surfaces. (column 46, lines 4-9)
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to silanized the surface using a functional group derived from (3- aminopropyl)triethoxysilane (APTES) in view of Fodor et al. teaching the use of aminopropyltriethoxysilane to allow silane compounds to polymerize on substrate surfaces.
Therefore, Walther-Antonio et al. in view of Fordor et al. renders claim 15 obvious.
6. Claim 16 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 1 and further in view of Chinese Patent Application Publication No. CN 103304721 to Chen et al.
I.) Regarding applicant’s claim 16, as noted above, Walther-Antonio et al. anticipates claim 1 from which claim 16 depends.
Claim 16 recites that silanized surface comprises benzaldehyde-protected silane groups.
Walther-Antonio et al. does not teach that silanized surface comprises benzaldehyde-protected silane groups.
Chen et al. teaches protecting silane with amino benzaldehyde.
It would have been obvious to modify Walther-Antonio et al. to provide the silanized surface comprises benzaldehyde-protected silane groups as taught by Chen et al. for protection purposes.
Therefore. Walther-Antonio et al. in view of Chen et al. renders claim 16 obvious.
8. Claim 20 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 17 and further in view of Beyer et al.
I.) Regarding applicant’s claim 20, as noted above, over Walther-Antonio et al. anticipates claim 17 from which claim 20 depends.
Claim 20 recites that the elongated support is a glass capillary tube.
Walther-Antonio et al. does not teach that the elongated support is a glass capillary tube.
As noted above, Beyer et al. teaches binding nucleic acids to support materials and that capillary tubes can be used as functionalized supports. [0035]
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to conduct HPV screening using a capillary tube as a supporting structure as taught by Beyer et al. and include the first and second nucleic acids on or in the capillary tube for contacting the same with a test fluid for screening.
Therefore, Walther-Antonio et al. in view of Beyer et al. renders claim 20 obvious.
9. Claim 21 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 17 and further in view of Jackson et al.
I.) Regarding applicant’s claim 21, as noted above, Walther-Antonio et al. anticipates claim 17 from which claim 21 depends.
Claim 21 recites that the nucleic acid is immobilized on the silanized surface via biotin-streptavidin coupling.
Walther-Antonio et al. teaches dry-stored nucleic acids ([0007]) but does not teach that the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling.
As noted above, Jackson et al. teaches streptavidin-biotin coupling of functional ligands or indicator molecules to substrates. [[0058], [0071]
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to have the nucleic acid immobilized on the silanized surface via biotin-streptavidin coupling in view of Jackson et al. teaching biotin-streptavidin coupling.
Therefore, Walther-Antonio et al. in view of Jackson et al. renders claim 21 obvious.
10. Claim 28 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 17 and further in view Fodor et al.
I.) Regarding applicant’s claim 28, as noted above, Walther-Antonio et al. anticipates claim 17 from which claim 28 depends.
Claim 28 recites that the silanized surface comprises functional groups derived APTES, AEAPTES, AEAPTMS or AHAMTES.
Walther-Antonio et al. does not teach how the surface is silanized.
As noted above, Fodor et al. teaches the use of aminopropyltriethoxysilane to allow silane compounds to polymerize on substrate surfaces. (column 46, lines 4-9)
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to silanized the surface using a functional group derived from (3- aminopropyl)triethoxysilane (APTES) in view of Fodor et al. teaching the use of aminopropyltriethoxysilane to allow silane compounds to polymerize on substrate surfaces.
Therefore, Walther-Antonio et al. in view of Fordor et al. renders claim 28 obvious.
11. Claim 29 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 17 and further in view of Chen et al.
I.) Regarding applicant’s claim 29, as noted above, Walther-Antonio et al. anticipates claim 17 from which claim 29 depends.
Claim 29 recites that silanized surface comprises benzaldehyde-protected silane groups.
Walther-Antonio et al. does not teach that silanized surface comprises benzaldehyde-protected silane groups.
As noted above, Chen et al. teaches protecting silane with amino benzaldehyde.
It would have been obvious to modify Walther-Antonio et al. to provide the silanized surface comprises benzaldehyde-protected silane groups as taught by Chen et al. for protection purposes.
Therefore. Walther-Antonio et al. in view of Chen et al. renders claim 29 obvious.
12. Claim 30 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. Walther-Antonio et al. discloses kit that includes an elongate support (a glass vial, [0007]) comprising a first surface (a first interior surface, [0007]), a first nucleic acid immobilized on the first surface (a first nucleic acid reversibly attached to a first interior surface, Para. (0007)), and a second nucleic acid reversibly attached to the first surface or to a second surface (a first nucleic acid reversibly attached to a first interior surface and a second nucleic acid immobilized on a second interior surface, [0007]), wherein the first surface is silanized (silanized clear glass vials, [0042]), wherein the first nucleic acid is complementary to a first segment of a selected nucleic acid marker, and wherein the second nucleic acid is complementary to a second segment of the selected nucleic acid marker (wherein the first nucleic acid is complementary to a first nucleic acid sequence of a selected marker, and wherein the second nucleic acid is complementary to a second nucleic acid sequence of the marker, (0007]).
Walther-Antonio et al. teaches that the first nucleic acid is complementary to a nucleic acid sequence of the marker and is labeled with a means for visual detection, and where the second nucleic acid is complementary to a second nucleic acid sequence of the marker and that HRP is the means for visual detection. [0009]
Alternatively, the terms “first” and “second” in relationship to the nucleic acids can be interchanged.
Walther-Antonio, et al. does not specifically teach a separate vessel containing the substrate which reacts with HRP (means for visual detection).
It would have been obvious to provide the elongate support (glass vial) in kit for at home testing with the vial reading on both the elongate support and receptacle for receiving a biological fluid sample. Walther-Antonio et al. teaches paper strip substrate that interacts with HRP for visual detection as shown in Fig. 1.
I.) Regarding applicant’s claim 30, as noted above Walther-Antonio et al. renders all the elements of claim 30 obvious.
Therefore, Walther-Antonio et al. renders claim 30 obvious.
II.) Regarding applicant’s claim 34, as noted above Walther-Antonio et al. renders claim 30 obvious from which claim 34 depends.
Claim 34 recites that the marker is from one or more high-risk human papillomavirus (HPV) strains or from an infectious agent.
As noted above, Walther-Antonio et al. teaches that the marker can be from one or more high-risk human papillomavirus (HPV) strains (e.g., one or more of HPV 16, HPV 18, HPV 31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 56, HPV 58, HPV 59, and HPV 68). [0007]
Therefore, Walther-Antonio et al. anticipates claim 34.
13. Claim 31 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 1 and further in view of Jackson et al.
I.) Regarding applicant’s claim 31, as noted above, Walther-Antonio et al. render claim 30 obvious from which claim 31 depends.
Claim 31 recites that the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling, and wherein the second nucleic acid is dry-stored on the first surface or the second surface.
Walther-Antonio et al. teaches dry-stored nucleic acids ([0007]) but does not teach that the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling.
As noted above, Jackson et al. teaches streptavidin-biotin coupling of functional ligands or indicator molecules to substrates. [[0058], [0071]
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to have the first nucleic acid is immobilized on the first surface via biotin-streptavidin coupling, in view of Jackson et al. teaching biotin-streptavidin coupling, and have the second nucleic acid dry-stored on the first surface or the second surface.
Alternatively, the terms “first” and “second” in relationship to the nucleic acids can be interchanged.
Therefore, Walther-Antonio et al. in view of Jackson et al. renders claim 31 obvious.
14. Claim 41 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 30 and further in view of Fodor et al.
I.) Regarding applicant’s claim 41, as noted above, Walther-Antonio et al. renders claim 30 obvious from which claim 41 depends.
Claim 41 recites that the silanized first surface comprises functional groups derived from (3- aminopropyl)triethoxysilane (APTES), N-(2-amionethyl)-3-aminopropyltriethoxysilane (AEAPTES), N-(2-aminoethyl)-3-aminopropyltrimethoxysilane (AEAPTMS), or N-(6- aminohexyl)amionmethyltriethoxysilane (AHAMTES).
Walther-Antonio et al. does not teach how the surface is silanized.
As noted above, Fodor et al. teaches the use of aminopropyltriethoxysilane to allow silane compounds to polymerize on substrate surfaces. (column 46, lines 4-9)
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to silanized the surface using a functional group derived from (3- aminopropyl)triethoxysilane (APTES) in view of Fodor et al. teaching the use of aminopropyltriethoxysilane to allow silane compounds to polymerize on substrate surfaces.
Therefore, Walther-Antonio et al. in view of Fordor et al. renders claim 41 obvious.
15. Claim 42 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 30 and further in view of Chinese Patent Application Publication No. CN 103304721 to Chen et al.
I.) Regarding applicant’s claim 42, as noted above, Walther-Antonio et al. renders claim 30 from which claim 42 depends.
Claim 42 recites that silanized surface comprises benzaldehyde-protected silane groups.
Walther-Antonio et al. does not teach that silanized surface comprises benzaldehyde-protected silane groups.
As noted above, Chen et al. teaches protecting silane with amino benzaldehyde.
It would have been obvious to modify Walther-Antonio et al. to provide the silanized surface comprises benzaldehyde-protected silane groups as taught by Chen et al. for protection purposes.
Therefore. Walther-Antonio et al. in view of Chen et al. renders claim 42 obvious.
16. Claim 45 is rejected under 35 USC 103 as being unpatentable over Walther-Antonio et al. as applied to claim 30 and further in view of U.S. Patent Application Publication No. 2004/0209267 to Beyer et al.
I.) Regarding applicant’s claim 45, as noted above, over Walther-Antonio et al. renders claim 30 obvious from which claim 45 depends.
Claim 45 recites that the elongated support is a glass capillary tube.
Walther-Antonio et al. does not teach that the elongated support is a glass capillary tube.
As noted above, Beyer et al. teaches binding nucleic acids to support materials and that capillary tubes can be used as functionalized supports. [0035]
It would have been obvious to one of ordinary skill in the art to modify Walther-Antonio et al. to conduct HPV screening using a capillary tube as a supporting structure as taught by Beyer et al. and include the first and second nucleic acids on or in the capillary tube for contacting the same with a test fluid for screening.
Therefore, Walther-Antonio et al. in view of Beyer et al. renders claim 45 obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2018/0045716 to Lin et al. teaches that solid supports for attachment of binding pair members for the detection of target analytes may be in the form of a bead, particle, fiber, film, membrane, tube, well, a strip, rod, a planar surface such as a plate, and the like. [0027]
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798