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 .
DETAILED ACTION
Status of Claims
Claims 76-95 are pending and have been examined.
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 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.
Claim(s) 76-95 are rejected under 35 U.S.C. 103 as being unpatentable over Chou (US2016/0003744, Pub Date: 01/07/2016) in view of Jardemark et al. (US 2004/0182707, hereinafter “Jardemark”) and Blainey et al. (US2016/0312275).
Regarding claim 76, Chou teaches an article comprising: a microwell array comprising a well (paragraph 0080) comprising a nanostructure and a nanoparticle positioned distally on an end of the nanostructure (paragraph 0083), wherein the nanoparticle is configured to interact with incident light via surface plasmonic resonance (paragraphs 0069, 0096 and 0153). However, Chou fails to specifically teach that the article comprises a semipermeable membrane configured to seal the well and the well has a diameter selected from a range of 10 micrometers and 50 micrometers.
Jardemark teaches throughout the publication arrays having nanotips for simultaneously or sequentially measuring properties of cells (abstract). More specifically, Jardemark teaches that the nanotips are present within apertures of a well (paragraph 0020), with each well sized to receive a cell and having a diameter of less than 100 micrometers, less than 50 micrometers, less than 25 micrometers or less than 10 micrometers (paragraph 0132).
Blainey teaches throughout the publication a microfabricated device defining a high density array of microwells (abstract). More specifically, Blainey teaches that a membrane may be connected, sealed or partially sealed to the microfabricated device to retain at least one biological entity in the microwell (paragraph 0053), wherein the membrane may be semi-permeable (paragraph 0056) and once sealed with the semi-permeable membrane, nutrients are allowed to diffuse into the microwells but the membranes prevent all of some of the cells from moving out of the microwells (paragraph 0190).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the well diameter of Chou to include a diameter in the range of 10 micrometers to 50 micrometers as taught by Jardemark because Chou is generic with respect to the dimensions of the wells that can be incorporated in the article and one skilled in the art would have been motivated to use the appropriate size wells for detection of the desired analytes. Additionally, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate within the article of Chou a membrane sealing the well as taught by Blainey because it would have been desirable to allow reagents to enter the wells for analysis but prevent cells from leaving for further analysis (Blainey, paragraph 0190).
Although Chou in view of Blainey does not explicitly teach that the nutrients allowed to enter the wells is a lysis reagent and a lysate is prevented from leaving the well, such limitation is drawn to intended use of the claimed article and therefore the prior art must only be capable of performing the recited intended use. So long as the semi-permeable membrane in the article of Chou in view of Blainey is capable of allowing a lysis reagent into the well and preventing a lysate from leaving the well, it reads on the claims. Chou in view of Blainey teach the same structural limitations as recited in the claims and further teaches that lysis-promoters can be included within the wells (Blainey, paragraph 0189), therefore it is considered capable of performing the same intended use.
Regarding claim 77, Chou teaches the article further comprising a reaction entity immobilized relative to the nanoparticle (paragraphs 0083 and 0100).
Regarding claim 78, Chou teaches the article wherein binding of an analyte to the reaction entity causes a change in light refracted from the nanoparticle (paragraphs 0158-0159).
Regarding claim 79, Chou teaches the article further comprising a detector positioned to detect light refracted from the nanoparticle (paragraph 0153, reader).
Regarding claim 80, Chou teaches the article wherein the incident light is plane polarized (paragraph 0154).
Regarding claim 81, Chou teaches the article further comprising a light source positioned to direct the incident light at the nanoparticle (paragraphs 0153-0155).
Regarding claim 82, Chou teaches the article wherein only one nanoparticle is attached to the nanostructure (paragraph 0088).
Regarding claim 83, Chou teaches the article wherein the nanoparticle has an average diameter of less than about 3 nm (paragraph 0090).
Regarding claim 84, Chou teaches the article wherein the nanostructure is substantially vertically aligned (see, for example, Figures 3 and 6).
Regarding claim 85, Chou teaches the article wherein the nanostructure has a length of less than about 5 micrometers (paragraph 0092).
Regarding claim 86, Chou teaches the article wherein the nanostructure has an average cross-sectional diameter of at least about 50 nm (paragraphs 0090-0092).
Regarding claim 87, Chou teaches the article wherein the nanostructure comprises a semiconductor (paragraph 0091).
Regarding claim 88, Chou teaches the article wherein the nanostructure and the microwell array have substantially the same composition (paragraph 0091).
Regarding claim 89, Chou teaches the article wherein the nanostructure and the microwell array define a unitary material (paragraph 0091).
Regarding claim 90, Chou in view of Jardemark teaches the article wherein the well has a diameter selected from a range of 20 micrometers and 40 micrometers (Jardemark, paragraphs 0132).
Regarding claim 91, Chou teaches the article wherein the microwell array comprises a plurality of wells each comprising nanoparticles positioned distally on the end of nanostructures (paragraph 0080 and see Figures 3 and 6).
Regarding claim 92, Chou teaches the article wherein the nanostructures have an average pitch of less than 100 micrometers (paragraph 0093).
Regarding claim 93, Chou in view of Jardemark and Blainey teach the article wherein the semipermeable membrane is configured to prevent passage of cells (Blainey, paragraph 0190).
Regarding claim 94, Chou in view of Jardemark and Blainey teach the article wherein the semipermeable membrane comprises polycarbonate (Blainey, paragraph 0056).
Regarding claim 95, Chou in view of Jardemark and Blainey teach the article wherein the semipermeable membrane has a pore size small enough to retain at least some or all of the cells in the microwell, such as a few microns or even less than or equal to 0.2 microns such that pore size depends on the material and the function of the membrane (Blainey, paragraph 0056). Although Blainey does not explicitly teach a pore size of 10 nm, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 95 are for any particular purpose or solve any stated problem, and the prior art teaches that pore size may be varied based on the membrane material used, permeability needs, and the biological material to be contained (Blainey, paragraph 0056). Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the microwell array art.
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 76 and 94-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-4 of U.S. Patent No. 12,246,321.
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claim 76, Patent 321 recites a method, comprising: allowing a lysing reagent to enter a well of a microwell array through a semipermeable membrane sealing the well, wherein the semipermeable membrane is configured to prevent a lysate from leaving the well; lysing a cell within the well to release an analyte suspected of being able to bind a reaction entity; applying electromagnetic radiation to a nanoparticle at least partially coated with the reaction entity, wherein: (i) the nanoparticle is configured to interact with the electromagnetic radiation via electric resonance and/or magnetic resonance to alter the electromagnetic radiation; and (ii) the well comprises a nanostructure and the nanoparticle is positioned distally on an end of the nanostructure; and determining the altered electromagnetic radiation (see patent claim 1).
Patent claim 3 reads on the limitations of instant claim 94 and patent claim 4 reads on the limitations of instant claim 95.
Conclusion
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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