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 .
Response to Arguments
Applicant's arguments filed June 8, 2026 have been fully considered but they are not persuasive. At the outset, the Examiner notes that Applicant has amended the claims to overcome the rejections under 35 U.S.C. 112(b), thus those rejections have been removed.
With respect to the prior art, Applicant has provided a declaration and arguments to show unexpected results with respect to isolating circulating tumor cells with the claimed device. Specifically, Applicant has argued that the instant invention provides a 200,000,000 fold enrichment compared to the prior art, and that the prior art is incapable of producing such results. Based on Applicant’s arguments, and the declaration, the enrichment is the result of an “active pressure-driven deformability-based cell separation” performed with the instantly claimed device. The Examiner contends that both the arguments and the declaration are not commensurate with the scope of the claims do not require active pressure driven flow that generates cell deformability. As currently presented, the instant claims do not recite a structural element that generates the active flow through the device, thus the claims are sufficiently broad so as to read on a device that meets the structural elements and operates by passive capillary flow. Also, the Examiner notes that the claims are directed to a device, thus patentability is determined by the structural elements of the device, and not its intended use. As such, the Examiner has not found Applicant’s arguments to be persuasive as they are not commensurate with the scope of the claims, and are largely directed to the intended use of the claimed device. Therefore, based on the teachings of the prior art, and the arguments provided here, the Examiner contends that the limitations of the instant claims are taught by the combination of references cited below, thus the claims are not in condition for allowance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al., (US 2005/0042766) in view of Miyauchi et al., (US 2004/0125266) in view of Singhal et al., (US 2012/0015347), and further in view of Kamm et al., (US 2014/0057311).
Regarding claim 1, Ohman et al., teach a microfluidic liquid flow system (paragraph 0001) comprising a channel structure having an inlet aperture (paragraph 0060), an exit aperture (paragraph 0060), a cover (paragraph 0060), a plurality of microposts between the inlet and exit apertures (figure 9) wherein the microposts have a diameter of 20 µm (paragraph 0050), and are evenly spaced over a support(paragraph 0050) wherein the space between microposts are evenly spaced (paragraph 0050). Ohman et al., teach the space between microposts ranging between 0.1 to 1000 µm, preferably between 1 to 100 µm (paragraph 0055), with the height of the columns being higher than 10 µm (paragraph 0055). Ohman et al., also teach that the distance between microposts can be selected so that capillary flow of liquids can be maintained (paragraph 0055), thus it is within the skill of one of ordinary skill in the art to select an aspect ratio to allow for capillary flow of liquids through the device. Also, the Examiner notes that capillary flow generally exhibits a linear velocity ranging from 0.5 to 1.5 mm/s, thus the capillary flow taught by Ohman et al., would be expected to be within the claimed linear velocity range. Additionally, the Examiner notes that the linear velocity is not a structural element of the claimed device, and contends that the structural elements taught by Ohman et al., would be capable of exhibiting a linear velocity ranging from 0.5 to 1.5 mm/s. Ohman et al., do not teach an aspect ratio ranging from 3.5 to 5.
Miyauchi et al., teach a functioning substrate having columnar micropillars wherein the micropillars have an aspect ratio of 4 (paragraphs 0039, 0180). Miyauchi et al., teach that it is advantageous to provide micropillars having an aspect ratio of 4 as a means of forming a substrate that can be utilized for a wide variety of applications (paragraph 0039).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ohman et al., wherein the microposts have an aspect ratio of 4 in order to provide a substrate that can be utilized in a wide variety of applications as taught by Miyauchi et al. Ohman et al., in view of Miyauchi et al., teach the microposts having a diameter of 20 µm, but do not explicitly teach microposts having a width ranging from 15 to 40 µm.
Singhal et al., teach a microfluidic device wherein the device comprises a reversible trap having spaced apart structural members (posts, paragraphs 0013, 0016, 0017) wherein the structural members have a width ranging from 5 to 30 microns. The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III C). Singhal et al., teach that the structural members allow the fluid to flow through a chamber while providing size selection for a particle within the fluid, which is identical to the microposts of Ohman et al., which also allow for fluid flow while separating particles. As such, one of ordinary skill in the art would have found it obvious to utilize the microposts of Ohman et al., with the structural members of Singhal et al., as they operate in a similar manner.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ohman et al., in view of Miyauchi et al., to utilize posts having a width ranging from 5 to 30 microns as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. Ohman et al., in view of Miyauchi et al., in view of Singhal et al., do not teach a single row of post elements.
Kamm et al., teach a microfluidic device comprising a plurality of posts located in microchannels (Abstract, paragraph 0008) wherein the posts can be arranged in a single row (paragraph 0089). The Examiner is reading this combination as applying a known technique to a known device to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III D). Kamm et al., teach that the plurality of posts can be arranged in a variety of orientations depending on the intended use of the device (paragraph 0089). As such, the Examiner contends that one of ordinary skill in the art would have found it obvious from the teachings of Kamm et al., to for a single row of posts depending on the intended use of the device. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ohman et al., in view of Miyauchi et al., in view of Singhal et al., wherein the plurality of posts are arranged in a single row as taught by Kamm et al., as applying a known technique to a known device to yield predictable results requires only routine skill in the art.
Regarding claims 2 and 3, Ohman et al., teach the microposts having a circular shape (paragraph 0050).
Regarding claim 4, Ohman et al., teach the microposts having an even height (paragraph 0050).
Regarding claim 5, Ohman et al., teach the microposts formed directly on the surface of a support (paragraphs 0053, 0056).
Regarding claims 6 and 10, Singhal et al., teach a substrate formed from PDMS (paragraph 0082).
Claim(s) 7 is/are rejected under35 U.S.C. 103 as being unpatentable over Ohman et al., (US 2005/0042766) in view of Miyauchi et al., (US 2004/0125266) in view of Singhal et al., (US 2012/0015347)in view of Kamm et al., (US2014/0057311) as applied to claim 1 above, and further in view of Delamarche et al., (US 2011/0117539).
Regarding claim 7, Ohman et al., in view of Miyauchi et al., in view of Singhal et al., in view of Kamm et al., do not teach a transparent cover.
Delamarche et al., teach a device comprising a filter having a plurality of circular posts (paragraph 0079) wherein the device also comprises a cover having an optically transparent window (paragraph 0093). The Examiner is reading this combination as applying a known technique to a known device to yield predictable results which would have been obvious to one of ordinary skill in the art. One of ordinary skill in the art would have recognized that providing a transparent cover prevents contamination from the ambient environment while allowing a user to optically view or analyze the fluid as it flows through the nanopillar array.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ohman et al., in view of Miyauchi et al., in view of Singhal et al, in view of Kamm et al., further in view of Delamarche et al., to provide a transparent cover as applying a known technique to a known device requires ordinary skill in the art.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohman et al., (US 2005/0042766) in view of Miyauchi et al., (US 2004/0125266) in view of Singhal et al., (US 2012/0015347) in view of Kamm et al., (US 2014/0057311) as applied to claim 1 above, and further in view of Sloan et al., (US 2015/0231627).
Regarding claims 8 and 9, Ohman et al., in view of Miyauchi et al., in view of Singhal et al., in view of Kamm et al., do not teach microposts comprising a surfactant.
Sloan et al., teach a device for sample collection and separation wherein surfaces along the fluid pathway are coated with a surfactant (paragraph 0153). Sloan et al., also teach the surfactant being a pluronic acid (paragraph 0153). Sloan et al., teach that it is advantageous to provide a surfactant as a means of generating a wettable surface to hydrophobic layers and to facilitate filling of the pathway with a liquid sample (paragraph 0153).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ohman et al., in view of Miyauchi et al., in view of Singhal et al., in view of Kamm et al., to coat the pillars with a surfactant in order to provide a wettable surface to hydrophobic layers and to facilitate filling of the flow path with a liquid sample as taught by Sloan et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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