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 .
Claim Interpretation
Claim 31 recites detecting whether a cell has a “thin membrane” or a “thick membrane”, wherein the thin membrane is “adapted to receive a nanopore” and thick membrane is “not adapted to receive a nanopore.” The terms “thin membrane” and “thick membrane” are interpreted functionally and comparatively; rather than as requiring a precise numerical thickness. A “thin membrane” is interpreted as a lipid structure that is thin enough to function as a lipid bilayer capable of supporting nanopore insertion. A “thick membrane” is interpreted as a lipid structure thicker than a bilayer that is not suitable for nanopore insertion without further thinning.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 19-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12/173,367. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims 19 and claim 1 of ‘367 recite a nanopore based sequencing chip comprising an array of cells, each comprising a well; a flow chamber coupled to the nanopore based sequencing chip; and a processor or circuitry configured to: flow a salt buffer solution over the array of cells to fill the wells; flow a lipid and solvent mixture over the array of cells to deposit the lipid and solvent mixture over at least some of the wells; detect whether a lipid bilayer or lipid membrane greater than three lipid molecules thick is present by applying a voltage stimulus and measuring a resultant change in voltage; and selectively applying an electrical lip-thinning stimulus only to a portion of the cells. Claim 1 of ‘367 anticipates that of claim 19.
As to dependent claims 20-28, claims 2-9 of ‘367 anticipate the claimed subject matter.
As to claims 29-30, the claims of ‘367 the limitations are routine design and control refinements that do not introduce new inventive concept and therefore do not render the claims patentably distinct.
As to claims 31-34, the claims merely restate the same invention using different terminology (“thin membrane” versus “lipid bilayer” and “thick membrane” versus “lipid membrane greater than three lipid molecules thick”) and repeat the same electrical detection and selective thinning control logic. Claim 10 of ‘367, recites the same nanopore sequencing system, the same electrical membrane thickness detection mechanism, and same selective thinning stimulus control loop. The additional dependent limitations in claims 32-43 merely are either anticipated by or obvious operational refinements, parameter values or implementation details to claims 11-18 of ‘367 and do not render the claims patentably distinct.
Claims 19-43 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,465,240. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 is an obvious variant of claim 1 of ‘240. Claim 1 of ‘240 recites flowing a salt buffer solution to fill wells; flowing a lipid and solvent mixture to deposit lipid membranes; determining whether a lipid bilayer or lipid membrane is present by applying a voltage stimulus and measuring a resultant change in voltage using a determined threshold; and selectively applying a lipid thinning stimulus only to cells lacking a lipid bilayer. Claim 1 of ‘240 recites the same system and operational steps except the membrane is greater than three lipid molecules thick. The use of slightly different terminology by characterizing thick membranes as being “greater than three lipid molecules thick” does not render the claim patentably distinct.
As to dependent claims 20-30, claims 2-5 of ‘240 anticipate the claimed subject matter.
As to claims 31-34, the claims merely restate the same invention using different terminology (“thin membrane” versus “lipid bilayer” and “thick membrane” versus “lipid membrane”) and repeats the same electrical detection and selective thinning control logic. Claim 10 of ‘676, recites the same nanopore sequencing system, the same electrical membrane thickness detection mechanism, and same selective thinning stimulus control loop. The additional dependent limitations in claims 32-43 are anticipated operational refinements, parameter values or implementation details to claims 5-9 of ‘240 and do not render the claims patentably distinct.
Conclusion
There are no prior art rejections over the claims.
Chen et al. (US 2014/0203464) discloses a system and method for forming lipid bilayers over nanopores in a sequencing chip and applying electrical agitation or pulses to facilitate nanopore insertion or membrane reset. Chen et al. further teaches monitoring bilayer integrity using electrical signals. However, Chen et al. does not teach distinguishing a lipid bilayer form a liquid membrane greater than three lipid molecules thick, nor does it selectively apply a thinning stimulus only to overly thick membranes based on the electrical thickness classification as claimed.
Chen et al. (US 9041420) teaches applying electrical measurement stimuli across lipid bilayers and measuring resistance, capacitance, or ionic current to assess membrane integrity. Chen et al. further discloses corrective electrical pulses to reset or reform membranes when defects are detected. However, Chen et al. does not classify membrane thickness into bilayer versus three lipid molecules thick (or thin versus thick), selectively apply a thinning stimulus only to overly thick membranes exceeding a thickness threshold as claimed.
Davis et al (US 2014/0034497) relates to nanopore sequencing chips. Davis discloses a method for forming a lipid bilayer in a nanopore sequencing chip by applying an appropriate voltage to a cell and measuring the current to determine if the bilayer is formed. The cells are divided into two groups (a) cells with a bilayer and no longer needs voltage applied and (b) cells that do not have a bilayer formed. The cells without the bilayer will have the bilayer formation electric voltage applied while the cells with the bilayer will no long need voltage. Davis et al. teaches selective application of a stimulus across cells but fails to teach detecting a thick membrane over the cell and selectively applying a thinning stimulus to such cells as required by the claims.
Davis et al. (US 2015/0153302) discloses a system for creating bilayers for use with nanopore sensors. The system comprises a nano pore chip having an array of cells; flowing a salt buffer solution over the cells to form a lipid bilayer and after forming, increasing voltage pulses are applied and the voltage where the layer breaks is measured, if the voltage is acceptable then a bubble is formed to remake the bilayer. Davis fails to teach detecting if the membrane formed is a bilayer or thicker membrane using electrical measurements, or selectively applying a lipid-thinning stimulus as claimed.
The prior teaches bilayer formation on sequencing chips and electrically monitoring the layers formed but fails to teach or suggest the claimed combination of voltage based membrane thickness classification and selective thinning of a thick membrane.
Conclusion
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/CACHET I. PROCTOR/
Examiner
Art Unit 1715
/CACHET I PROCTOR/Primary Examiner, Art Unit 1712