Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
Claims 1-18 are pending and have been examined.
Priority
This application, Serial No. 18/612,744 (PGPub: US2025/0027145) was filed 03/21/2024. This application is a divisional of 16/851,884, filed 04/17/2020 (US Patent 11,965,210), which is a continuation of 15/703,909 filed 09/13/2017 (US Patent 10,662,471), which is a continuation of 13/745,688 filed 01/18/2013 (abandoned), which claims benefit of 61/589,196 filed 01/20/2012 and claims benefit of 61/589,719 filed 01/23/2012 and claims benefit of 61/600,227 filed 02/17/2012.
Information Disclosure Statements
No Information Disclosure Statements have been filed.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-16 are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Olasagasti et al (U.S. Patent Application Publication No. US 2010/0035260 A1, published 11 February 2010).
Regarding claims 1 and 10, Olasagasti et al teach methods and systems (Abstract) comprising a chip comprising at least one cell, in the form of an independently addressable nanopore (paragraph 0112-0113). Each nanopore comprises an electrode (paragraph 0126) and is in a membrane (paragraph 0113), thereby forming the claimed cell. Olasagasti et al further teach a controller, in the form of voltage control logic on a hardware system (paragraph 0219; see also paragraph 0246), which varies the voltage across the nanopore (paragraph 0114). Olasagasti et al also teach the system comprises a microprocessor (paragraph 0192) and measures an electrical signal (e.g., current or conductance; paragraph 0125-0144), and a portion of the molecule, in the form of a nucleotide, in the nanopore is identified (paragraph 0007). Olasagasti et al further teach the detection of varying probing voltages (paragraph 0146).
It is noted that the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958); See MPEP 2144.04 III). Thus, providing a controller and/or processor to perform the claimed functions of the system is obvious.
Regarding claims 2 and 11, Olasagasti et al teach voltages of 100 mV or more (paragraph 0212), and voltages of 150 mV (paragraph 0064), which include the claimed range.
In addition, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Regarding claims 3-4 and 12-13, Olasagasti et al teach the device measures an current or conductance (paragraph 0125).
Regarding claims 5 and 14, Olasagasti et al teach the detection molecule is a tag (i.e., label; paragraph 0125).
Regarding claims 6-7 and 15-16, Olasagasti et al teach the detection molecule is a polymer, in the form of a polynucleotide (paragraph 0125).
In addition, with respect to claim 14-16, it is noted that the limitations therein are drawn to a molecule, which is not actually part of the claimed system, and thus do not further limit the claims.
Claims 2 and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Olasagasti et al (U.S. Patent Application Publication No. US 2010/0035260 A1, published 11 February 2010) as applied to claims 1 and 10 above, and further in view of Denison et al (U.S. Patent No. 6,362,002 B1, issued 26 March 2002).
It is noted that while claims 2 and 11 have been rejected as described above, the claims are also obvious using the interpretation outlined below.
Regarding claims 2 and 11, the method and system of claims 1 and 10 are discussed above.
Denison et al teach a system (Example 3) comprising a computer (column 9, lines 20-25) and membrane nanopore (column 8, lines 25-40), wherein the nanopore has electrodes proximal thereto (column 16, lines 25-35). Denison et al teach the voltage is varied over voltages starting at 120 mv (column 5, lines 25-55), and also discusses the range of 120 mV to 140 mV (Example 6). Denison et al further teach the system has the added advantage of allowing detection of single nucleotide variations or mutations in the target (column 5, lines 50-65). Thus, Denison et al teach the known techniques of using varied voltages.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, the claimed range merely represents an obvious variant and/or routine optimization of the values of the cited prior art.
It would therefore have been obvious to a person of ordinary skill in the art to have modified the method and system of Olasagasti et al with the teachings of Denison et al to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have the added advantage of allowing detection of single nucleotide variations or mutations in the target as explicitly taught by Denison et al (column 5, lines 50-65). In addition, it would have been obvious to the ordinary artisan that the known techniques of Denison et al could have been applied to the method and system of Olasagasti et al with predictable results because the known techniques of Denison et al predictably results in voltages useful for moving polymers through nanopores and identifying them.
Claims 8-9 and 17-18 are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Olasagasti et al (U.S. Patent Application Publication No. US 2010/0035260 A1, published 11 February 2010) as applied to claims 1 and 10 above, and further in view of Zhang et al (U.S. Patent Application Publication No. US 2011/0037486 A1, published 17 February 2011, filed 2 August 2010).
Regarding claims 8-9 and 17-18, the method and system of claims 1 and 10 are discussed above.
Olasagasti et al do not teach voltage waveforms.
However, Zhang et al teach a system (paragraph 0003) comprising a processor (i.e., computer; paragraph 0118) and a nanopore (paragraph 0114). The system utilizes a sinusoidal alternating current waveform (paragraph 0084 and claim 6 of Zhang et al), and has the added advantage of allowing identification of DNA sequences (Abstract). Thus, Zhang et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art to have modified the method and system of Olasagasti et al with the teachings of Zhang et al to arrive at the instantly claimed method and system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have the added advantage of allowing identification of DNA sequences as explicitly taught by Zhang et al (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Zhang et al could have been applied to Olasagasti et al with predictable results because the known techniques of Zhang et al predictably results in voltages useful for moving polymers through nanopores and identifying them.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,662,471.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding claim 1 and 10, Patent 471 recites a method for identifying a molecule or portion thereof, the method comprising: (a) providing a chip comprising at least one nanopore in a membrane that is disposed adjacent or in proximity to an electrode, wherein the electrode is adapted to detect a current passing through the nanopore; (b) inserting a portion of a molecule into the nanopore; (c) varying a voltage applied across the nanopore and/or across the membrane, wherein the voltage is varied across a range of voltages from 120 mV to 150 mV; (d) measuring the current at a plurality of applied voltages while the portion of the molecule is inserted within the nanopore; and (e) identifying the portion of the molecule that is inserted within the nanopore based on the measured current at the plurality of applied voltages.
Regarding instant claims 2-9 and 11-18, see patent claims 2-14.
Conclusion
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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