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 .
Response to Amendment
The preliminary amendment filed on 08/21/2025 is entered and acknowledged by the Examiner. Claims 3-7, 10, 12, 14, and 18 have been amended. Claim 21 has been canceled. Claims are 1-20 currently pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/04/2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner. An initialed copy accompanies this Office Action.
Drawings
The drawings filed on 04/04/2024 have been considered.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
In claim 1, at line 6, replace a phrase “coats the section” with “coats a section”.
Claims 2-6 depend from claim 1 and are objected based on their dependencies.
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.
Claim 13 is 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 13 recites the limitation "the liquid composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0282325 A1 (hereinafter Nolan).
Regarding claim 20, Nolan discloses a conductive substrate (claimed support) including a conductive polymer coated glass or plastic (See [0056]). The glass or plastic substrate meets the claimed (a) optically transparent substrate. The conductive polymer coating on the glass or plastic substrate meets the claimed (b) layer of a conductive organic polymer on a surface of the substrate.
The reference specifically or inherently meets each of the claimed limitations in their broadest interpretations. The reference is anticipatory.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0282325 A1 (hereinafter Nolan).
With respect to claim 1, Nolan disclose a method of analyzing a population of cells using (SIMS) secondary ion mass spectrometry (See Abstract). The method comprises a substrate that is a conductive substrate including a transparent conductive oxide (TCO) coated glass or plastic, a conductive polymer coated glass or plastic, or a semiconductor wafer where the conductive polymers include PEODT/PSS, poly(thiophene), and the like (See [0056]). Nolan disclose that the method comprises a step of adding an array of cells (biological analyte) onto the conductive substrate, i.e., conductive polymer coated substrate, (See [0054] and [0055]).
Nolan failed to explicitly disclose (i) the layer of polymer is between the sample and the substrate, (ii) the layer of polymer coats a section on the opposite side to the substrate, or (iii) both (i) and (ii) as required in claim 1.
Give, that Nolan discloses an array of cells (biological analyte) is applied onto a substrate where the substrate can be a conductive substrate selected from a small group of three substrates including a conductive polymer coated glass or plastic with the glass or plastic substrate being an optically transparent substrate and the conductive polymer coating being the layer of conductive organic polymer. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply the array of cells onto the conductive polymer coated glass or plastic. This combination would result in (1) a layer of conductive polymer coated on top of the glass or plastic substrate with the array of cells on top of the conductive polymer coated layer and putting the conductive polymer coated layer between the array of cells and substrate as required in the instant claim.
Regarding claim 2, Nolan discloses that the conductive polymer is selected from a small group of two polymers including PEDOT/PSS (See [0056]).
Regarding claim 3, Nolan discloses that the conductive substrate comprises a conductive polymer layer coated onto a glass or plastic substrate to form conductive polymer coated glass or plastic substrate (See [0056]), but failed to disclose the thickness of the conductive polymer coating layer being in the range of 1-500 nm. Nonetheless, it would have been obvious for a skilled artisan at the time the invention was filed to coat the glass or plastic substrate of Nolan with a conductive polymer layer as thin as possible in order to reduce production cost and not to have the conductive polymer interfere with the analysis measurement.
Regarding claim 4, Nolan discloses a cell cross-linking attachments and reagents is coated to the substrate with binding moiety to provide an attachment site for cells to bind non-covalently to the substrate (See [0058]).
Regarding claims 5 and 6, Nolan discloses that the array of cells includes single cells (See [0055]). The array of cells fulfill the claimed sample.
Regarding claim 7, Nolan discloses that the substrate includes glass or plastic (See [0056]). The substrate of Nolan fulfills the claimed substrate.
Claims 8-12 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan (US 2016/0282325 A1) in view of CA 3114763 A1 (hereinafter Kendall).
With respect to claims 8 and 9, Nolan disclose a method of analyzing a population of cells using (SIMS) secondary ion mass spectrometry (See Abstract). The method comprises a conductive substrate including a conductive polymer coated glass or plastic where the conductive polymers is selected from a group of PEODT/PSS and poly(thiophene) (See [0056]). Nolan discloses the claimed step (b) of applying a conductive polymer layer to a substrate, but failed to disclose the substrate was functionalized (pretreated) prior to being coated with the conductive polymer layer as recited in step (a) of claim 8.
Kendall discloses using an agent including siloxane to increase a binding (adhesion) of a polymer coating to a substrate (electrode) prior to adding the polymer coating as required in step (a) of claim 8 (See [0392]). The siloxane of Kendall fulfills the claimed silanized in claim 9. Kendall discloses a substrate and/or microstructure is an electrode made from a material including plastic, ITO or glass (See [0048], [0287], [0599], and [0656]). The substrate of Kendall includes optically transparent material. Kendall further discloses the polymer including a conductive polymer such as PEDOT:PSS (See [0288], [0362], and [0364]). Kendall discloses that the substrate and/or microstructure is useful for performing measurements on a biological subject (See Abstract).
It would have been obvious for a skilled artisan at the time the invention was made to modify the substrate of Nolan by treating the substrate with siloxane prior to coating the substrate with a conductive polymer in order to increase a binding (adhesion) of the conductive polymer coating to a substrate as suggested by Kendall.
Regarding claim 10, Nolan discloses that the cell cross-linking attachments and reagents is coated to the substrate with binding moiety to provide an attachment site for cells to bind non-covalently to the substrate where the substrate contains a conductive polymer layer (See [0056] and [0058]). Nolan also discloses that the cell sample includes soft tissues (See [0055]). Thus, the cross-linking attachments and reagents is coated to the conductive polymer layer coated substrate to provide an attachment site for soft tissue cell.
Regarding claim 11, Kendall discloses a siloxane as an agent to improve binding (See [0392]). The siloxane of Kendall fulfills the claimed siloxane cross-linking agent.
Regarding claim 12, Kendall discloses that the polymer coating solution (a liquid composition) comprises of an organic solvent and polymer that is applied by spray coating and spin coating and allowed to dry in situ (See [0367] [0387], and [0389]). The drying would remove the solvent by evaporation.
Regarding claim 14, Nolan discloses a method that results in a layer of conductive polymer coated on top of the glass or plastic substrate with the array of cells on top of the layer of conductive polymer coated and putting the layer of conductive polymer coated between the array of cells and substrate (See claim 1 above). Thus, the array of cells (biological analytes) is placed on the layer of polymer on opposite side of the substrate as required in the instant claim.
Regarding claim 15, Nolan discloses analyzing the cell sample using secondary ion mass spectrometry (See [0006]).
Regarding claim 16, Nolan discloses a method for preparing a sample by placing cells (analyte sample) on a substrate where the substrate includes a non-conductive substrate or an insulating substrate of glass or plastic (See [0054] and [0056]). In other words, the cells can be place onto a glass substrate or a plastic substrate (an optically transparent substrate) as required in step (a) of the instant claim.
Nolan does not disclose a step (b) of applying a layer of a conductive organic polymer on top of the cell sample.
Kendall discloses that the conductive polymer (molecularly imprinted polymer) can help bind the analyte (cell sample) of interest (See [00362], [00363], and [0369]).
Therefore, it would have been obvious for a skilled artisan at the time the invention was filed to apply a conductive polymer layer on top of the analyte (cell sample) of Nolan in order to bind the analyte of interest to the substrate.
Regarding claim 17, Kendall discloses that the polymer coating solution (a liquid composition) comprises of an organic solvent and polymer that is applied by spray coating and spin coating and allowed to dry in situ (See [0367] [0387], and [0389]). The drying would remove the solvent by evaporation.
Claims 13, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nolan (US 2016/0282325 A1) and Kendall (CA 3114763 A1) as applied to the claims above, and further in view of WO 2018203830 A1 (hereinafter Qiang).
Nolan and Kendall are relied upon as set forth above.
Regarding claims 13 and 18, Nolan and Kendall disclose a PEDOT/PSS conductive polymer coated glass substrate by a polymer coating solution (a liquid composition) comprises of an organic solvent (See claims 8 and 11-12 above), but failed to disclose coating composition comprises DMSO4 as required in claims 13 and 18.
Qiang discloses a coating composition comprises of PEDOT:PSS, organic solvent, and DMSO2 dopant to enhance electrical conductivity (See Abstract, [0052], and [0063]). Qiang discloses a glass slide (glass substrate) is coated with the PEDOT:PSS coating composition (See [0069]; Example 6).
It would have been obvious for a skilled artisan to formulate a polymer coating composition by doping the conductive polymer of Nolan and Kendall with a DMSO2 in order to enhance electrical conductivity as suggested by Qiang.
Regarding claim 19, Nolan discloses analyzing the cell sample using secondary ion mass spectrometry (See [0006]). Kendall also discloses measuring the analyte with a technique including mass spectrometry (See [0736]).
In view of the foregoing, the above claims have failed to patentably distinguish over the applied art.
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 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHANH TUAN NGUYEN whose telephone number is (571)272-8082. The examiner can normally be reached M-F 9:00 AM to 5:00 PM EST.
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/KHANH T NGUYEN/Primary Examiner, Art Unit 1761