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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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.
Claims 18 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.
Regarding claim 18, the claim recites the limitation of “the cellulose nanofibers which are aggregated” which lacks antecedent basis since there has not been aggregated nanofibers previously disclosed. It is not clear if this is supposed to refer to a previously disclosed limitation, or if it should read as “the cellulose nanofibers are aggregated. For the purposes of examination, it will be interpreted as the latter.
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.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being Anticipated by Singh et al. Novel label-free method for extracellular-vesicle enrichment from biological fluids and cell culture medium (hereinafter referred to as Singh).1
Regarding claim 14, Singh teaches a device and method to be used for capturing extracellular vesicles in a sample solution, the device comprising a nanostructure body (cellulose nanofibers) capable of capturing an extracellular vesicle (Background).wherein the nanostructure body of Singh is a structure body made of cellulose nanofibers as claimed (Background). As all structural limitations of the claim are met, Singh teaches the claim in its entirety.
Regarding claims 20-25, the claims are directed towards a production method of the device of claim 14 and are product-by-process claims. In such an instance, 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). Therefore, the Singh reference is deemed to read on the claimed limitations as the structure of the device itself reads on the claimed device.
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 to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Ziaei Review: Isolation and Detection of Tumor-Derived Extracellular Vesicles (hereinafter referred to as Ziaei).
Regarding claim 15, Singh teaches the claimed invention but does not explicitly disclose the gap between the nanofibers of the nanostructure body as being between 1 and 100nm as claimed. Ziaei discloses a system and method for detecting extracellular vesicles using nanowires as shown in fig. 2, in which the gap between wires is within the claimed range (section 2.1, page 2006). It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Ziaei with those of Singh in order to provide the same gap to allow for a high density of interstitial traps so that cells larger than the array are blocked and smaller structures which are not wanted pass through (Ziaei, page 2006).
Regarding claim 19, Singh teaches the claimed invention but does not explicitly disclose the sample solution as being saliva as claimed. Ziaei teaches a system and method for detecting extracellular vesicles using nanowires in which the extracellular vesicles can be located in saliva (Introduction, page 2004). It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Ziaei with those of Singh to test for extracellular vesicles in any sample solution where they may exist, including saliva since it is easily collected in a non-invasive manner.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Sehaqui et al. Stretchable and Strong Cellulose Nanopaper Structures Based on Polymer-Coated Nanofiber Networks: An Alternative to Nonwoven Porous Membranes from Electrospinning (hereinafter referred to as Sehaqui).
Regarding claim 16, Singh teaches the claimed invention including the cellulose nanofibers but does not explicitly disclose the nanopores in the structure body. Sehaqui teaches a cellulose membrane (fabric) comprising nanopores within the claimed range (page 3663 describes the pores as being 10-15nm) for use in biomedical environments (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Sehaqui with those of Singh to provide a nanopore body in the device of Singh in order to filter out the desired object from a fluid under test and to increase the surface area for interaction between the components.
Regarding claim 17, Singh teaches the claimed invention including the cellulose nanofibers but does not explicitly teach the nanofibers as having a width of 15 to 100 nm as claimed. Sehaqui teaches a nonwoven cellulose membrane (fabric) comprising nanopores for use in biomedical environments which includes nanofibrillated cellulose with a diameter of 5-20 nm (page 3661, introduction). It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Sehaqui with those of Singh to provide a nanopore body formed from 20nm nanofibers in the device of Singh in order to filter out the desired object from a fluid under test with a fine fiber structure.
Regarding claim 18, Singh teaches the claimed invention including the cellulose nanofibers but does not explicitly teach the nanostructure body as being a film of the cellulose fibers and/or the cellulose fibers that are aggregated. Sehaqui teaches a cellulose membrane or fabric formed from cellulose nanofibers which is therefore a film or aggregation of nanofibers as claimed. It would have been obvious to one of ordinary skill in the art at the time of filing to have combined the teachings of Sehaqui with those of Singh in order to provide a cellulose nanopaper structure as a filter in biomedical applications.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art of Park, Tseng, Nagrath and Skog is related to similar devices and methods for detection of bioparticles using nanotechnology.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A. Shabman whose telephone number is (571)272-8589. The examiner can normally be reached M-F 8:00-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Laura Martin can be reached at 571-272-2160. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK A SHABMAN/ Primary Examiner, Art Unit 2855
1 All non-patent literature references applied have been provided in the parent case 17/289,282 and are not attached to this action.
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