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 .
Status of Claims
The claim set submitted on 25 OCTOBER 2023 is acknowledged.
In the claim set, Claims 1-15 are acknowledged, considered and considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 NOVEMBER 2023 was filed. 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 as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 3, character 122. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The disclosure is objected to because of the following informalities:
The use of the term CYANORESIN™, DYNEON™, CYTOP™, FLURORPEL™, [00050], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities: The word ‘aluminum’ is misspelled. There are two instances. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
An “electrode assembly configured to generate an electric field and cause reversible electrowetting of a PCR mixture” in claim 1; “electrode assembly … to generate an electric field within the thermocycling chamber” in claim 9 and 10.
An “assembly” does not connote any particular structure. The specification describes the “assembly” to be two concentric electrodes, [00029, 00036], two electrodes, with both electrodes disposed on the substrate, [00034], or with one electrode disposed on the substrate and the other electrode configured to contact the liquid sample from a different angle, [00034], one or more planar electrodes, [00035].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 6 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 6 does not further define the invention. In Claim 1 a ‘thermocycling chamber’ is claimed (singular); then in Claim 6, a ‘plurality of thermocycling chambers’ is claimed (plural). Claim 6 broadens Claim 1, from which it depends from.
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 1, 3, 6-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN, US Publication No. 2013/0115607 A1, submitted on the Information Disclosure Statement on 17 NOVEMBER 2023, US Patent Application Publications Cite No. 3, and further in view of Krupenkin, T. & Taylor, J.A. Reverse electrowetting as a new approach to high-power energy harvesting. Nat. Commun. 2:448 doi: 10.1038/ncomms1454 (2011).
Applicant’s invention is directed towards a device, a PCR system.
Regarding Claim 1, the NIELSEN reference discloses a PCR system, [0018, 0038], Figure 18A-D, comprising: a thermocycling chamber , Figure 18A-D, reaction chamber, [0175, 0176], comprising an electrode assembly, [0173]; and an optical sensor configured to obtain optical signals from the thermocycling chamber, [0113].
The NIELSEN reference discloses the claimed invention, but is silent in regard to wherein the thermocycling chamber comprising an electrode assembly configured to generate an electric field and cause reversible electrowetting of a PCR mixture within the thermocycling chamber.
The KRUPENKIN reference discloses a system, Figure 1, 4, 6 and 7, comprising: a chamber, Figure 4, ‘chamber’, comprising an electrode assembly configured to generate an electrical field and cause reversible electrowetting of a sample within the chamber, page 2-3 ‘Reverse electrowetting concept’.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of NIELSEN with the electrode assembly configured to generate an electrical field and cause reversible electrowetting as taught by KRUPENKIN so that one is able to convert mechanical energy of liquid motion into electrical current, page 2.
Additional Disclosures Included are: Claim 3: wherein the PCR system according to claim 1, wherein the optical sensor is a fluorescence sensor, [0272]. ;Claim 6: wherein the PCR system according to claim 1, wherein the PCR system comprises a plurality of thermocycling chambers and the plurality of thermocycling chambers are independently operable, Figure 18A-D.; Claim 7: wherein the PCR system according to claim 1, wherein the thermocycling chamber fluidically isolated from any other thermocycling chamber that may be present on the substrate, Figure 18A-D.; Claim 8: wherein the PCR system according to claim 1, wherein the thermocycling chamber is provided with one or more capillary pressure barriers on an internal surface thereof, Figure 2, [0231].
Applicant’s invention is directed towards a method, a method of manufacturing.
Regarding Claim 9, the NIELSEN reference discloses a method of manufacturing a PCR system, comprising: forming a thermocycling chamber, [0162, 0163, 0164]; and arranging an electrode assembly, [0173].
The NIELSEN reference disclose the claimed method, but is silent in regards to wherein the electrode assembly is arranged so as to be operable to generate an electric field within the thermocycling chamber.
The KRUPENKIN reference discloses a system, Figure 1, 4, 6 and 7, comprising: a chamber, Figure 4, ‘chamber’, comprising an electrode assembly configured to generate an electrical field and cause reversible electrowetting of a sample within the chamber, page 2-3 ‘Reverse electrowetting concept’.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of NIELSEN with the electrode assembly configured to generate an electrical field and cause reversible electrowetting as taught by KRUPENKIN so that one is able to convert mechanical energy of liquid motion into electrical current, page 2.
Applicant’s invention is directed towards a method.
Regarding Claim 10, the reference NIELSEN discloses a method of performing PCR, Claim 61, comprising:
introducing a liquid volume into a thermocycling chamber of a PCR system, [0227], wherein the liquid volume comprises a nucleic acid sample suspected of containing a nucleic acid of interest, abstract, [0008, 0010, 0011], and the thermocycling chamber comprises an electrode assembly, [0162-0167], configured to generate an electric field within the thermocycling chamber, [0175, 0176]; applying a first voltage across the electrode assembly to cause the liquid volume to electrowet within the thermocycling chamber, [0241]; subjecting the liquid volume to amplification by polymerase chain reaction, [0011]; applying a second voltage across the electrode assembly, [0079, 0080, 0241]; and detecting an optical signal from the droplet, [0113].
The NIELSEN reference discloses the claimed invention, but is silent in regard to wherein the thermocycling chamber comprising an electrode assembly configured to reverse the electrowetting and cause the liquid to from a droplet.
The KRUPENKIN reference discloses a system, Figure 1, 4, 6 and 7, comprising: a chamber, Figure 4, ‘chamber’, comprising an electrode assembly configured to reverse the electrowetting and cause the liquid to from a droplet, page 3-4, REWOD energy production.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of NIELSEN with the electrode assembly configured to generate an electrical field and cause reversible electrowetting as taught by KRUPENKIN so that one is able to convert mechanical energy of liquid motion into electrical current, page 2.
Additional Disclosures Included are: Claim 11: wherein the method according to claim 10, wherein the second voltage is applied during at least one amplification cycle to detect an optical signal from the droplet during amplification cycle, [0255, 0256].; Claim 12: wherein the method according to claim 10, wherein the second voltage comprises a zero or near zero voltage, [0247, 0256, 0574-0581]. ; Claim 13: wherein the method according to claim 10, wherein subjecting the liquid volume to amplification by polymerase chain reaction comprises thermocycling the electrowetted liquid volume, [0104].
Regarding Claim 15, the combination above suggest the claimed invention, but is silent in regards to wherein the first voltage and the second voltage are oscillated at a frequency of 100 Hz.
NIELSEN discloses the voltage can be applied at a first and second voltage, [0574-0581] and teaches the voltage to be applied over any period of time, [0256], suitable for achieving good separation of the analyte, but is silent in regards to the voltages are oscillated a frequency of 100 Hz.
Since NIELSEN teaches the voltage to be applied at any voltage and over any period of time suitable for achieving good separation of the analyte (e.g., amplification products), it would be obvious to one having ordinary skill in the art before the effective filing date to modify the NIELSEN so that the first voltage and the second voltage are oscillated at a frequency of 100 Hz to either amplify or provide good separation of the desired analytes, [0256].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN, US Publication No. 2013/0115607 A1, submitted on the Information Disclosure Statement on 17 NOVEMBER 2023, US Patent Application Publications Cite No. 3, and further in view of Krupenkin, T. & Taylor, J.A. Reverse electrowetting as a new approach to high-power energy harvesting. Nat. Commun. 2:448 doi: 10.1038/ncomms1454 (2011).And further in view of COBB, US Publication No. 2004/0069656 A1.
Regarding Claim 4, the combination above suggests the claimed invention, but is silent in regards to wherein PCR system according to claim 1, wherein the electrode assembly comprises a hydrophobic coating of PTFE, cyanoethyl pullulan (CEP), or octadecyltrichlorosilane.
The COBB reference discloses a PCR system, abstract, [0037], comprising an electrode assembly, [0084, 0085], configured to generate an electric field, [0084, 0085], and an optical sensor configured to obtain optical signals, Figure 15a, and wherein the electrode assembly comprises a hydrophobic coating of PTFE, cyanoethyl pullulan (CEP), or octadecyltrichlorosilane, [0086].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention so that electrode assembly comprises a hydrophobic coating of PTFE as taught by COBB to provide prevent any electrochemical reduction or oxidation of the electrode and to provide mechanical stability to the device as well as provide structural integrity of the electrode in the thermocycling of the chamber.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN, US Publication No. 2013/0115607 A1, submitted on the Information Disclosure Statement on 17 NOVEMBER 2023, US Patent Application Publications Cite No. 3, in view of Krupenkin, T. & Taylor, J.A. Reverse electrowetting as a new approach to high-power energy harvesting. Nat. Commun. 2:448 doi: 10.1038/ncomms1454 (2011), and further in view of PAMULA, US Patent 7,763,471 B2.
Regarding Claim 14, the combination above suggests the claimed invention, but is silent in regards to wherein an oil is provided into the thermocycling chamber.
The PAMULA reference discloses a method for thermocycling, Column 39 line 65 – Column 40 line 7, where a liquid volume comprises a nucleic acid sample suspected of containing a nucleic acid of interest, Column 3 line 66-Column 4 line 3, and the thermocycling chamber comprises an electrode assembly configured to generate an electric field , Column 3 line 63-65, Column 32 line 15-32, wherein a chamber is provided with oil, Column 48 line 26-29.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the combination to have an oil in the provided into the thermocycling chamber as taught by PAMULA to prevent proteins from sticking to electrodes, Column 33 line 44, and to use a filler fluid that is non-conductive, Column 48 line 26-29.
Allowable Subject Matter
Claims 2 and 5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The claim limitation directed to : wherein the electrode assembly comprises two concentric electrodes provided on a substrate on which the thermocycling chamber is disposed is not found or suggested in the prior art. While concentric electrodes are known; it is not taught or suggested in a PCR system, or device for performing thermocycling.
The claim limitation directed to : wherein the electrode assembly comprises a dielectric coating of polyimide, SU-8, silicon oxide, silicon nitride, aluminium oxide, aluminium nitride or any combination / stack thereof is not found or suggested in the prior art and field of invention of PCR system, thermocycling, electrowetting or reverse electrowetting. While it is known in the art that electrodes can have coatings, the electrode with coating as defined in Claim 5 in conjunction with any of PCR system, thermocycling, electrowetting or reverse electrowetting is not found or suggested in the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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