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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/08/2024, 10/13/2025 were filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because in Figure 19, the text at the top of the page is unreadable due to the size.
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 1-19 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 “a sample containing or suspected of containing” in line 3. The expression “suspected of” renders the limitation indefinite since the meaning of the expression depends solely on the subjective opinion of a person. See MPEP 273.05(b)(III). For the purpose of examination, the limitation will be interpreted as “a sample containing or capable of containing” for clarity.
Claim 1 recites “a target-permeable structural material associated with the aqueous phase/layer or the gaseous or oil/wax phase/layer or both” and is unclear if the target-permeable structural material is a positively recited element of the claimed device because “associated with” does not require the target-permeable structural material to be present in the device.
Further it is unclear whether “a target-permeable structural material” is referring to a material that is permeable to the previously recited target molecule, or a different target.
For prosecution, the limitation will be interpreted as the aqueous phase/layer or the gaseous or oil/wax phase/layer is capable of being used with a permeable material.
Claims 2-19 and 22 depended on claim 1 are also rejected for said dependency.
Claims 2 and 4 recite the limitation “a SIFT composition, system or device” and is unclear because there is no definition of “stabilized interface system” in the specifications and there is also no accepted meaning of SIFT in the art. Therefore, it would not be possible for one of ordinary skills in the art to determine the metes and bounds of claims. For prosecution, the limitation SIFT will be interpreted to mean a system comprising an interface between a fluid and a surface.
Claims 3 and 4 recite the limitation “a MIFT composition, system or device” and is unclear because there is no definition of “miscible interface system” in the specifications and there is also no accepted meaning of MIFT in the art. Therefore, it would not be possible for one of ordinary skills in the art to determine the metes and bounds of claims. For prosecution, the limitation MIFT will be interpreted to mean a system comprising a fluid miscible with a surface.
Claim 5 recites “such as a plate or tube or substance having a high susceptibility to magnetization”. The expression “such as” renders whether or not the plate or tube or substance is a required structural element. For prosecution, the limitation will be interpreted as exemplary language and does not positively recite plate or tube or substance.
Claim 5 recites “the strength of which depends on that of the applied magnetizing field, and which desists after removal of the applied field” and is unclear because “the strength of which” and “the applied magnetizing field” lacks antecedent basis. For prosecution, the limitation the limitation is deemed to be exemplary language, because the claim does not positively recite “plate or tube or substance”.
Claim 5 recites “high susceptibility to magnetization”. The term “high” is a relative term which renders the claim indefinite. The expression “high susceptibility” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the limitation will be interpreted as “susceptibility to magnetization” for clarity.
Claim 7 recites “the presence or amount of a target molecule” and lacks antecedent basis. For the purpose of examination, the limitation will be interpreted as “a presence or an amount of the target molecule” for clarity.
Claim 11 recites “the presence or amount of a target molecule” and lacks antecedent basis. For the purpose of examination, the limitation will be interpreted as “a presence or an amount of the target molecule” for clarity.
Claim 16 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations.
First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “selected from the group consisting of nucleic acids, proteins and cells” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: cells do not share a single structural similarity or a common use with nucleic acids and proteins.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claims 1-13, 16-19, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (US20130264287A1 published 10/10/2013; hereinafter Zhang).
Regarding claim 1, Zhang teaches a device for isolating, collecting and/or transferring target molecules to an area for assay, said transfer device (Poly(2-vinyl pyridine-b-dimethylsiloxane) Modified Substrate – Figs. 5a-f and Example 3)(materials and substrates with modified surfaces and/or switchable oleophilicity and oleophobicity in aqueous media – paragraph 3) comprising:
(a) a top portion configured for introduction of a sample containing a target molecule or target molecules (a top portion of a beaker for introducing a sample – Fig. 5a)
(b) a bottom portion with an area comprising one or more reagents for carrying out an assay or assays (a bottom portion of the beaker with a P2VP-b-PDMS modified surface – Figs. 5c-f and paragraph 104),
(c) an enclosure (a beaker – Figs. 5a-f and paragraph 104) comprising a central hollow body portion suitable for receiving a magnet magnetic force (the beaker comprising a central hollow portion and is capable of receiving a magnet magnetic force – Figs. 5a-f) (“suitable for receiving a magnet magnetic force” is an intended use of the enclosure and deem to read on a hollow enclosure capable of receive a magnetic force),
(d) at least one aqueous phase or layer (neutral water layer – Figs. 5a-f and paragraph 104) and at least one oil/wax or gaseous phase or layer (oil such as DCE – paragraph 104 and Fig. 5d) stabilized in proximity to one another with a target-permeable structural material (oil stabilized on the P2VP-b-PDMS modified surface – paragraph 104 and Fig. 5d) associated with the aqueous phase/layer or the gaseous or oil/wax phase/layer or both (a textile associated with the oil layer – Figs. 5a-f and paragraph 107).
Regarding claim 2, Zhang teaches the device according to claim 1, wherein the target-permeable structural material comprises or consists essentially of a SIFT composition, system or device (the device comprises an interface between the oil layer and the substrate – Figs. 5d-f and paragraph 104) (As shown in FIG. 5d, the DCE contact angle was 165.3˚ in the acidic water, indicating the oleophobicity of the block copolymer grafted textile – paragraph 107)(see 112b above).
Regarding claim 3, Zhang teaches the device according to claim 1, wherein the target-permeable structural material comprises or consists essentially of a MIFT composition, system or device (the device comprises oil that is miscible with the substrate – Figs. 5a-c and paragraph 104) (As shown in FIG. 5a, as soon as the DCE droplet touched the surface of the block copolymer grafted textile, which was immersed in water of pH 6.5 – paragraph 104)(see 112b above).
Regarding claim 4, Zhang teaches the device according to claim 1, wherein the target-permeable structural material comprises or consists essentially of a SIFT composition, system or device (the device comprises an interface between the oil layer and the substrate – Figs. 5d-f and paragraph 104) (As shown in FIG. 5d, the DCE contact angle was 165.3˚ in the acidic water, indicating the oleophobicity of the block copolymer grafted textile – paragraph 107)(see 112b above) and a MIFT composition, system or device (the device comprises oil that is miscible with the substrate – Figs. 5a-c and paragraph 104) (As shown in FIG. 5a, as soon as the DCE droplet touched the surface of the block copolymer grafted textile, which was immersed in water of pH 6.5 – paragraph 104)(see 112b above).
Regarding claim 5, Zhang teaches the device according to claim 1, wherein a portion of the device enclosure comprises at least one ferromagnetic body (the substrate may contain the nanostructures comprising a magnetic core and a shell – paragraph 17), such as a plate or tube or substance having a high susceptibility to magnetization, the strength of which depends on that of the applied magnetizing field, and which desists after removal of the applied field (see 112b for exemplary language).
Regarding claim 6, Zhang teaches the device according to claim 1, wherein a magnet is movable (“magnet is movable” is a intended use recitation of the enclosure and is deemed to read on an enclosure capable of being used with a magnet) in relation to the central hollow body portion of the enclosure (a magnet is capable of being used with the beaker – Figs. 5a-f) so that, when target molecules are to be collected, the magnet may be moved partially or completely inside the central hollow body portion and (the beaker is capable of containing a magnet – Figs. 5a-f), when the particles are to be released, the magnet may be moved partially or completely outside the device (the beaker is capable of not containing a magnet – Figs. 5a-f).
Regarding claim 7, Zhang teaches the device according to claim 1, wherein reagents for determining the presence or amount of a target molecule are within the device (“reagents for determining the presence or amount of a target molecule” is an intended use of the device and is deemed to read on an enclosure capable of holding reagents for determining the presence or amount of a target molecule) (the beaker is capable of holding reagents for determining the presence or amount of a target molecule – Figs. 5a-f and paragraph 104).
Regarding claim 8, Zhang teaches the device according to claim 7, wherein the reagents are lyophilized (“the reagents” is not positively recited in claim 7 and is deemed to read on an enclosure capable of holding lyophilized reagents) (the beaker is capable of holding lyophilized reagents – Figs. 5a-f and paragraph 104).
Regarding claim 9, Zhang teaches the device according to claim 7, wherein the reagents comprise one or more reagents for carrying out a loop mediated isothermal amplification assay, or a reverse transcriptase loop mediated isothermal amplification assay (“the reagents” is not positively recited in claim 7 and is deemed to read on an enclosure capable of holding reagents for carrying out a loop mediated isothermal amplification assay, or a reverse transcriptase loop mediated isothermal amplification assay) (the beaker is capable of holding reagents for carrying out a loop mediated isothermal amplification assay, or a reverse transcriptase loop mediated isothermal amplification assay – Figs. 5a-f and paragraph 104).
Regarding claim 10, Zhang teaches the device according to claim 7, wherein the reagents comprise one or more reagents for carrying out an assay selected from the group consisting of PCR, RT-PCR qPCR, qtPCR, multiplex PCR, assembly PCR and asymmetric PCR (“the reagents” is not positively recited in claim 7 and is deemed to read on an enclosure capable of holding reagents for carrying out an assay selected from the group consisting of PCR, RT-PCR qPCR, qtPCR, multiplex PCR, assembly PCR and asymmetric PCR) (the beaker is capable of holding reagents for carrying out an assay selected from the group consisting of PCR, RT-PCR qPCR, qtPCR, multiplex PCR, assembly PCR and asymmetric PCR – Figs. 5a-f and paragraph 104).
Regarding claim 11, Zhang teaches the device according to claim 1, wherein reagents for determining the presence or amount of a target molecule comprise immunoassay reagents (“reagents for determining the presence or amount of a target molecule” is an intended use of the device and is deemed to read on an enclosure capable of holding immunoassay reagents) (the beaker is capable of holding immunoassay reagents – Figs. 5a-f and paragraph 104).
Regarding claim 12, Zhang teaches the device according to claim 11, wherein the immunoassay reagents comprise one or more reagents for carrying out an assay selected from the group consisting of an enzyme immunoassay, an ELISA, a direct ELISA, an indirect ELISA, a sandwich ELISA, a competitive ELISA, an immunoenzymometric assay, a radioimmunoassay, a fluoroimmunoassay, a chemiluminescent immunoassay and a counting immunoassay (“the immunoassay reagents” is not positively recited in claim 11 and is deemed to read on an enclosure capable of holding reagents for carrying out an assay selected from the group consisting of an enzyme immunoassay, an ELISA, a direct ELISA, an indirect ELISA, a sandwich ELISA, a competitive ELISA, an immunoenzymometric assay, a radioimmunoassay, a fluoroimmunoassay, a chemiluminescent immunoassay and a counting immunoassay) (the beaker is capable of holding reagents for carrying out an assay selected from the group consisting of an enzyme immunoassay, an ELISA, a direct ELISA, an indirect ELISA, a sandwich ELISA, a competitive ELISA, an immunoenzymometric assay, a radioimmunoassay, a fluoroimmunoassay, a chemiluminescent immunoassay and a counting immunoassay– Figs. 5a-f and paragraph 104).
Regarding claim 13, Zhang teaches the device according to claim 1, wherein the top portion of the device comprises an aperture for introduction of a sample (beakers are well known in the art for having a top aperture – Figs. 5a-b and paragraph 104).
Regarding claim 16, Zhang teaches the device according to claim 1, wherein the target molecules are selected from the group consisting of nucleic acids, proteins and cells (“the target molecules” is not positively recited in claim 1 and is deemed to read on an enclosure capable of holding target molecules selected from the group consisting of nucleic acids, proteins and cells) (the beaker is capable of holding target molecules selected from the group consisting of nucleic acids, proteins and cells – Figs. 5a-f and paragraph 104).
Regarding claim 17, Zhang teaches the device according to claim 1, wherein the device is a multiplex device (“a multiplex device” is a intended use of the device and is deemed to read on a device capable of holding multiple elements) (the beaker holds multiple elements such as DCE, a substrate, and water – Figs. 5a-f and paragraph 104).
Regarding claim 18, Zhang teaches the device according to claim 17, wherein the multiplex device is a hexaplex device (“a hexaplex device” is a intended use of the device and is deemed to read on a device capable of holding six elements) (the beaker is capable of holding six elements – Figs. 5a-f).
Regarding claim 19, Zhang teaches the device according to claim 1, wherein the device is configured for simultaneously determining the presence or amount of different target molecules in a single sample (“simultaneously determining the presence or amount of different target molecules in a single sample” is a intended use of the device and is deemed to read on a device capable of performing the limitation) (the Poly(2-vinyl pyridine-b-dimethylsiloxane) modified substrate is capable of being single use to simultaneously determining the presence of different target molecules in a single sample – Figs. 5a-f and Example 3).
Regarding claim 22, Zhang teaches the device according to claim 1 which is a single-use device (“single-use device” is an intended use of the device and is deemed to read on a device capable of being single use) (the Poly(2-vinyl pyridine-b-dimethylsiloxane) modified substrate is capable of being single use – Figs. 5a-f and Example 3).
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 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Kezes et al (US Pat No. 4,803,998A published 02/14/1989; hereinafter Kezes).
Regarding claim 14, Zhang teaches the device according to claim 1,
However, Zhang does not teach wherein the device further comprises (e) an internally threaded portion and (f) an externally threaded sample collection device that may be disconnected from the device for sample collection and reconnected to the device in order to assay the sample for one or more target molecules.
Kezes teaches a device for transporting a sample wherein the device further comprises (e) an internally threaded portion (a cap 14 with having threads for attaching the cap to the vial – Fig. 1 and column 1 lines 54-55) and (f) an externally threaded sample collection device (an externally threaded open end 21 of a vial 12 comprising a swab 10 – Fig. 1 and column 2 lines 2-6) that may be disconnected from the device for sample collection and reconnected to the device in order to assay the sample for one or more target molecules (the swab 10 and the open end 21 are capable of being connected and disconnected from the cap for sample collection – Fig. 1 and column 2 lines 2-6). Kezes teaches to use a swab to reach difficult to reach areas and to prevent contact between the hands of the user and the area or material being tested (column 3 lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the substrate, as taught by Zhang, by placing the substate on a swab, taught by Kezes, to reach difficult to reach areas and to prevent contact between the hands of the user and the area or material being tested. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Zhang and Kezes teach devices for testing samples.
Regarding claim 15, Zhang, modified by Kezes, teaches the device according to claim 14, wherein the externally threaded sample collection device comprises a swab (the externally threaded open end 21 comprises the swab 10 and – Kezes Fig. 1 and column 2 lines 2-6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20140187666A1 – a device with aqueous and oil layers on a porous surface
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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