DETAILED ACTIONNotice 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 .
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.
Priority
This application is a U.S. National Stage (371) application of PCT/US2022/037386 filed on 07/15/2022 which claims priority to U.S. Provisional Application No. 63/203,315 filed on 07/16/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/08/2024 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and all references are considered except where they were lined through.
Claim Objections
Claim 45 is objected to because of the following informalities: the claim recites “wherein the device is configured employ one or more”. Adding the preposition “to” would grammatically correct the claim’s language to recite “wherein the device is configured to employ one or more”. Appropriate correction is required.
Claim Interpretation
Regarding claim 37, the term “color center” is interpreted as an optical element which has an optical surface that provides internal reflection in an imaging apparatus such as a microscope.
Regarding claim 44, the claim is a product by process claim that teaches the product of a device by the process of making it as recited by claim 37. Per MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, the device of claim 44 is evaluated as a functionalized multilayered device.
Claim 45 recites “configured employ one or more dynamical decoupling sequences to decouple the device from low frequency noise” and this is more drawn to intended use, and a device is evaluated on its functional and physical limitations.
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.
(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.
Claims 1-2, 4, 18, 20, 27, 34-35 and 44-45 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Cleveland et al. (US 10,481,155 B2).
Claim 1 recites:
“A device comprising:
a substrate having a top surface, wherein the substrate further comprises one or
more color centers in proximity to the top surface;
an optional adhesion layer disposed on the top surface of the substrate, wherein
the adhesion layer comprises an oxide;
a functionalized layer configured to contact a sample, wherein the functionalized
layer comprises one or more capture agents configured to capture a target; and
an interlayer disposed beneath the functionalized layer”.
Regarding claim 1, Cleveland teaches a device comprising a substrate having a top surface and that the substrate further comprises one or more color centers in proximity to the top surface
(Column 4, lines 29-33). Cleveland further teaches a functionalized layer configured to contact a sample and that the functionalized layer comprises one or more capture agents configured to capture a target
(Sheet 7 of 9, Fig. 9, “900”; column 20, lines 11-16). And Cleveland teaches an interlayer disposed beneath the functionalized layer (Column 20, lines 13, “Filter layer”; lines 64-67 of column 20 and lines 1-11 of column 21).
Regarding claim 2, Cleveland teaches that the substrate comprises a diamond, and that one or more color centers comprise a nitrogen vacancy in the diamond (Column 4, lines 29-33; column 4, lines 64-67).
Regarding claim 4, Cleveland teaches that the one or more color centers are disposed
at a depth of less than about 100 nm from the top surface (Column 20, lines 47-52).
Regarding claim 18, Cleveland teaches that the functionalized layer comprises a monolayer,
or the functionalized layer is configured to provide a biocompatible surface to the sample (Sheet 7 of 9, Fig. 9, “900”; column 20, lines 11-16 and 20-27).
Regarding claim 20, Cleveland teaches that the one or more capture agents are nucleic acids or aptamers (Column 23, lines 1-4).
Regarding claim 27, Cleveland teaches that the target comprises a biomolecule or a tagged biomolecule, and wherein the biomolecule comprises a protein (Column 24, lines 27-34).
Regarding claim 34, Cleveland teaches that the device further comprises a source configured to irradiate the substrate and/or the one or more color centers and that the device further comprises a detector configured to detect one or more output signals emitted from the substrate upon being irradiated (Column 21; lines 29-33).
Claim 35 recites:
“A method of detecting a target, the method comprising:
providing a sample to an active area of the device of claim 1
irradiating the device to excite the one or more color centers; and
detecting one or more output signals emitted from the substrate upon being
irradiated”.
Regarding claim 35, Cleveland teaches a method of detecting a target (Column 4, lines 29-33; column 24, lines 27-34). Cleveland further teaches providing a sample to an active area of the device (Column 4, lines 29-33; column 24, lines 27-34). And Cleveland teaches irradiating the device to excite the one or more color centers and detecting one or more output signals emitted from the substrate upon being irradiated (Column 21; lines 29-33).
The Applicant is reminded from the earlier interpretation of claim 45 that the claim’s language is drawn to intended use and a device is evaluated on its functional and physical limitations that do not distinguish it from the device of Cleveland as previously discussed.
Claims 37 and 40 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Rassman et al. (US 2005/0024642 A1).
Claim 37 recites:
“A method of preparing a device, the method comprising:
depositing an adhesion layer on a top surface of a substrate, wherein the substrate
comprises one or more color centers in proximity to the top surface;
reacting a top surface of the adhesion layer with a silanizing agent to provide an
interlayer, wherein a top surface of the interlayer comprises a reactive moiety; and
attaching a functionalized layer by way of the reactive moiety within the
interlayer, wherein the functionalized layer comprises one or more capture agents
configured to capture a target”.
Regarding claim 37, Rassman teaches a method of preparing a device (Abstract; [0018]). Rassman further teaches depositing an adhesion layer on a top surface of a substrate [0026]. And Rassman teaches that the substrate comprises one or more color centers in proximity to the top surface [0026-0027]. Rassman also teaches reacting a top surface of the adhesion layer with a silanizing agent to provide an interlayer [0043]. And Rassman teaches that a top surface of the interlayer comprises a reactive moiety and teaches attaching a functionalized layer by way of the reactive moiety within the
Interlayer [0043-0044]. Rassman also teaches that the functionalized layer comprises one or more capture agents configured to capture a target [0042-0043].
Regarding claim 40, Rassman teaches that attaching comprises providing a poly( ethylene glycol) group and optionally comprising the one or more capture agents ([0043], “Advantageously, thiols are
present or easily coupled to a variety of receptors/capture agents such as proteins, nucleic acids, and polyethylene glycols by a variety of attachment chemistries”).
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 (PHOSITA) 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.
Claims 5, 10 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Cleveland et al. (US 10,481,155 B2) as applied to claim 1 above, and further in view of Shimizu et al. (US 11,015,264 B2).
Claim 5 recites:
“The device of claim 1, wherein the adhesion layer is present,
and wherein the oxide of the adhesion layer comprises a silanizable oxide, an aluminum oxide, a
silicon oxide, a titanium oxide, or a patterned oxide”.
Regarding claims 5, 10 and 44, the teachings of Cleveland are previously discussed.
Regarding claim 10, Cleveland teaches that the device comprises an active area with color centers and an inactive area that does not have color centers (Column 4, lines 44-46; “The wide band-gap or insulating crystal that surrounds the color center plays the role of "vacuum" separating the color centers”). Cleveland teaches that the active area comprises the functionalized layer (Sheet 7 of 9, Fig. 8D, “900”, “902”). Cleveland teaches that the inactive area lacks the functionalized layer and referred to as wide band-gap or insulating crystal that surrounds the color center (Column 4, lines 40-51).
Regarding claims 5, 10 and 44, Cleveland does not teach that the adhesion layer is present and the oxide of the adhesion layer comprises a silanizable oxide, an aluminum oxide, a silicon oxide, a titanium oxide, or a patterned oxide.
Regarding claim 44, Cleveland does not teach that the device has an adhesion layer.
Regarding claims 5, 10 and 44, Shimizu teaches that the adhesion layer is present, and the oxide of the adhesion layer comprises silicon oxide (Column 10, lines 58-62; column 11, lines 21-23).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the adhesion layer of Shimizu with the device of Cleveland because Shimizu introduced a high-quality diamond substrate with a protective layer (oxide layer) to protect the high density of the NV centers in the diamond (Column 1, lines 30-34; column 10, lines 58-62). Shimizu further noted that as the number of NV centers contributing to detecting magnetism increases, magnetic sensitivity is improved (Column 13, lines 58-63). A PHOSITA would have had a reasonable expectation of success in combining the methods of Shimizu and Cleveland based on the methods being in the field of making and using diamond-based quantum sensors.
It would have been obvious for a PHOSITA to use the adhesion layer of Shimizu with the diamond-based quantum sensor of Cleveland to produce a sensor with improved detection and sensitivity.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cleveland et al. (US 10,481,155 B2) as applied to claim 1 above, and further in view of Chang et al. (JP2006189308 A).
Claim 12 recites:
“The device of claim 1, wherein the functionalized layer comprises a
poly( ethylene glycol) group, a perfluoroalkylene group, a perfluoroalkyleneoxy group, an
alkylene group, a fluoroalkylene group, or a heteroalkylene group”.
Regarding claim 12, the teachings of Cleveland are previously discussed.
Regarding claim 12, Cleveland does not teach that the functionalized layer comprises a poly( ethylene glycol) group, a perfluoroalkylene group, a perfluoroalkyleneoxy group, an alkylene group, a fluoroalkylene group, or a heteroalkylene group.
Regarding claim 12, Chang teaches that the functionalized layer comprises a poly( ethylene glycol) group ([0006]; [0019]).
It would have been obvious for a PHOSITA before the effective filing date of the application to include the poly( ethylene glycol) group of Chang in the functionalization of the diamond-based sensor of Cleveland because Chang noted that their technical advancements enhanced sensitivity and specificity of biomolecule detection, reduced interference from traditional support materials and facilitated analyzing complex biological samples (Abstract). A PHOSITA would have had a reasonable expectation of success in combining the methods of Chang and Cleveland based on the methods being in the field of making and using diamond-based quantum sensors.
It would have been obvious for a PHOSITA to use the poly (ethylene glycol) group of Chang with the diamond-based quantum sensor of Cleveland to produce a sensor with improved detection and sensitivity.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Cleveland et al. (US 10,481,155 B2) as applied to claim 1 above, and further in view of Wang et al. (US 2005/0197462 A1).
Claim 28 recite:
“The device of claim 1, wherein the interlayer comprises an alkylene group
or a heteroalkylene group”.
Regarding claim 28, the teachings of Cleveland are previously discussed.
Regarding claim 28, Cleveland does not teach that the interlayer comprises an alkylene group or a heteroalkylene group.
Regarding claim 28, Wang teaches using alkylene group to make a multilayered composition (Abstract; [0024]; [0101], claim 6)
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the alkylene group of Wang in the making of multilayered diamond-based quantum sensors of Cleveland because Wang’s alkylene group offered good tensile strength, good tear strength, strong resistance to creep, high temperature resistance, and good aging properties to the multilayered composition [0009]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Wang and Cleveland based on the methods being in the field of making and using multilayered sensing devices and products.
It would have been obvious for a PHOSITA to use the alkylene group of Wang in the making of multilayered diamond-based quantum sensor of Cleveland to produce a sensor with increased durability.
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Cleveland et al. (US 10,481,155 B2) as applied to claim 1 above, and further in view of Wagner et al. (US 2003/0003599 A1).
Claim 31 recites:
“The device of claim 1, wherein a thickness of the adhesion layer if present,
the interlayer, and the functionalized layer, taken together, is less than about 10 nm”.
Regarding claim 31, the teachings of Cleveland are previously discussed.
Regarding claim 31, Cleveland does not teach that a thickness of the adhesion layer if present, the interlayer, and the functionalized layer, taken together, is less than about 10 nm.
Regarding claim 32, Cleveland does not teach that an average number of capture agents present per μm2 of the functionalized layer is less than 10 or is about 0.01 to about 5.
Regarding claim 31, Wagner teaches that a thickness of the adhesion layer if present, the interlayer, and the functionalized layer, taken together, is less than about 10 nm [0054].
Regarding claim 32, Wagner teaches that an average number of capture agents present per μm2 of the functionalized layer is less than 10 or is about 0.01 to about 5 ([0065-0066]; [0071]). Wagner teaches that the arrays of the invention have any number of a plurality of different protein-capture agents [0071]. Typically, the array comprises at least about ten different protein-capture agents ([0065-0066]; [0071]).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the array of Wagner in the making of multilayered diamond-based quantum sensor of Cleveland because Wagner’s array assayed in parallel a multitude of proteins from a cell or a population of cells in an organism [0012]. A PHOSITA would have had a reasonable expectation of success in combining the methods of Wagner and Cleveland based on the methods being in the field of making and using multilayered sensing devices and products.
It would have been obvious for a PHOSITA to include the array of Wagner in the making of multilayered diamond-based quantum sensor of Cleveland to produce a sensor with increased screening ability.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Rassman et al. (US 2005/0024642 A1) as applied to claim 37 above, and further in view of Shimizu et al. (US 11,015,264 B2).
Claim 39 recites:
“The method of claim 37, wherein the substrate comprises a diamond, and
wherein the top surface of the substrate comprises an oxygen-terminated surface of the diamond”.
Regarding claim 39, the teachings of Rassman are previously discussed.
Regarding claim 39, Rassman does not teach that the substrate comprises a diamond, and
wherein the top surface of the substrate comprises an oxygen-terminated surface of the diamond.
Regarding claim 39, Shimizu teaches that the substrate comprises a diamond, and
wherein the top surface of the substrate comprises an oxygen-terminated surface of the diamond (Column 12, lines 4-10).
It would have been obvious for a PHOSITA before the effective filing date of the application to modify the substrate of Rassman with the diamond substrate of Shimizu because Shimizu noted that using a diamond substrate increases the sensitivity of the testing device for medical applications (Column 13, lines 63-66). A PHOSITA would have had a reasonable expectation of success in combining the methods of Shimizu and Rassman based on the methods being in the field of making and using multilayered optical devices and products.
It would have been obvious for a PHOSITA to use the diamond substrate of Shimizu in the imaging apparatus of Rassman to increase the sensitivity of the imaging apparatus.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Rassman et al. (US 2005/0024642 A1) as applied to claim 37 above, and further in view of Anderson et al. (Langmuir 2008, 24, 2240-2247).
Claim 41 recites:
“The method of claim 40, wherein said attaching comprises:
(i) providing a mixture of a first poly( ethylene glycol) group comprising the one or more
capture agents and a second poly( ethylene glycol) group that lacks the one or more capture
agents; or
(ii) providing a mixture of a first poly(ethylene glycol) group having a further reactive
moiety and a second poly( ethylene glycol) group that lacks the further reactive moiety; and
providing one or more capture reagents to react with the further reactive moiety”.
Regarding claim 41, the teachings of Rassman are previously discussed.
Regarding claim 41, Rassman does not teach (i) providing a mixture of a first poly( ethylene glycol) group comprising the one or more capture agents and a second poly( ethylene glycol) group that lacks the one or more capture agents; or (ii) providing a mixture of a first poly(ethylene glycol) group having a further reactive moiety and a second poly( ethylene glycol) group that lacks the further reactive moiety; and providing one or more capture reagents to react with the further reactive moiety.
Regarding claim 41, Anderson teaches that attaching comprises providing a mixture of a first poly (ethylene glycol) group comprising the one or more capture agents and a second poly (ethylene glycol) group that lacks the one or more capture agents (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the poly ethylene glycol functionalization mixture of Anderson with the multilayered assembly of Rassman because Anderson noted that their functionalization mixture significantly reduced nonspecific binding (Abstract). A PHOSITA would have had a reasonable expectation of success in combining the methods of Anderson and Rassman based on the methods being in the field of making and using multilayered sensing devices and products.
It would have been obvious for a PHOSITA to use the functionalization mixture of Anderson in the imaging apparatus of Rassman to increase the specificity of the imaging apparatus.
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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