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.
Response to Arguments
Applicant's arguments filed 15 September 2026 have been fully considered but they are not persuasive. With regard to amended claim 14, the claim now includes the limitation of “the nanostructure body comprises at least one nanopore having an average size of 30 nm or greater and smaller than 1000 nm.” This limitation is still deemed to be taught by the prior art as detailed below as it is interpreted as the body has at least one nanopore wherein that nanopore has an average size in the claimed range, rather than the totality of the nanopores in the system have an average size in that range. In other words, a single nanopore in the body with a 30 or 40 nm pore size would satisfy the limitation. It is further noted that a change in size of an element
is generally recognized as being within the level of ordinary skill in the art,1 and therefore pores outside of the claimed ranges may also be considered an obvious variation in the size if rewritten or interpreted as the nanostructure comprises a plurality of nanopores wherein the average size of every of the in the body nanopores is between 30 and 1000 nm or similar. Therefore, all claims remain rejected the nanopore size is still deemed taught.
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 § 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) 14 is/are rejected under 35 U.S.C. 103 by Singh et al. Novel label-free method for extracellular-vesicle enrichment from biological fluids and cell culture medium (hereinafter referred to as Singh)2 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 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. does not explicitly disclose the nanopores in the structure body. Sehaqui teaches a cellulose membrane (fabric) comprising nanopores within the claimed range (page 3664 discloses at least one pore which has an average size of 30nm or more, “few pores are larger than 30-40nm”) 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 16, Singh teaches the claim in its entirety. does not explicitly disclose the nanopores in the structure body. Sehaqui teaches a cellulose membrane (fabric) comprising nanopores within the claimed range (page 3664 discloses at least one pore which has an average size of 30nm or more, “few pores are larger than 30-40nm”) 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.
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, Singh and Sehaqui are deemed to read on the claimed limitations as the structure of the device itself reads on the claimed device.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Sehaqui and futher in view of Ziaei Review: Isolation and Detection of Tumor-Derived Extracellular Vesicles (hereinafter referred to as Ziaei).
Regarding claim 15, Singh and Sehaqui teach the claimed invention but do 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 and Sehaqui 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 and Sehaqui teach 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 and Sehaqui 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/MARK A SHABMAN/Primary Examiner, Art Unit 2855
1 In re Rose, 105 USPQ 237 (CCPA 1955),
2 All non-patent literature references applied have been provided in the parent case 17/289,282 and are not attached to this action.
