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 .
Preliminary Remark
Claims 1-12 and 16-22 are canceled.
Claims 29-33 are new.
Election/Restrictions
Applicant’s election without traverse of Group IV in the reply filed on September 23, 2025 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 23, 2025.
Information Disclosure Statement
The IDS received on September 30, 2022 and June 21, 2023 are proper and are being considered by the Examiner.
Drawings
The drawings received on September 30, 2022 are acceptable.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 23-27 and 29-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mutlu et al. (WO 2018/223132 A1, published December 2018).
With regard to instant claim 23, Mutlu et al. teach a device comprising the below reproduced structure (from Fig. 15A, see below):
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As seen, the device comprises:
a binding tube having a first chamber at a first end of the binding tube and a second chamber at a second end of the binding tube (see middle narrower section (or binding tube), and the left and the right respective larger chambers as the fist and second chambers, respectively); and
a first source of force configured to act on the first chamber and constructed and arranged, upon activation, to create flow conditions for a sample in the binding tube that results in a first binding partner in the sample chemically binding to a second binding partner in the sample to create a third binding partner, the flow conditions including a particle size dependent migration velocity differential in the sample between the first binding partner and the second binding partner and between the first binding partner and the third binding partner1 (see velocity differential shown in Fig. 1A; also “disclosure provides oscillatory fluidic systems for focusing of particles in a fluid sample into one or more streamlines within a fluid flowing in a channel … includes a fluid oscillator for alternating a direction of flow in a channel; and a controller arranged and configured to transmit control signals to the fluid oscillator to generate a repeating oscillating flow profile of the fluid sample in the channel, wherein the flow profile includes at least one step in a first direction of flow and at least one step in a second direction of flow opposite to the first direction of flow … thereby focusing the particles into one or more streamlines within the flowing within the channel”, page 4, lines 1-9; “a fluid oscillator that includes a source of pressure”, page 4, line 14-15; see Fig. 1B, for the pressure system that directs the pressure direction between the first and the second chamber).
The device as discussed above can also be described as having a first lumen (or the first chamber2) having a first proximal opening and a first distal opening; a second tube comprising a second lumen having a second proximal opening and a second distal opening, the second proximal opening in fluid communication with the first distal opening; and a source of a sample suspended in a viscoelastic fluid in fluid communication with the first proximal opening (see below):
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(also, “particles, e.g., bioparticles and cells, focus into streamlines in the same way and the same locations as existing inertial and viscoelastic focusing systems”, page 3, lines 27-31)
With regard to claim 24, the diameter of the second tube is less than the diameter of the first tube (see above).
With regard to claim 25, the second proximal opening is positioned centrally about an axis of flow of the viscoelastic fluid through the first tube near the first distal opening (see the opening of the second proximal lumen is directly centered to the opening of the first distal end of the first lumen).
With regard to claims 26, 29, and 30 as discussed above, the device is configured to oscillate the fluid flow from the left lumen to the right lumen (i.e., first lumen to the second lumen), and therefore, the fluid will flow from the first proximal opening to the first distal opening and then to the second distal opening via the oscillatory fluid movement (as discussed above).
With regard to claim 27, because the structure of the claimed device is highly identical3 to the device of Mutlu et al., absent evidence to the contrary, a concentrated stream of a component of a sample would necessarily be collected.
With regard to claim 31, the source of force (or oscillatory fluidic system) provides for a flowrate of the viscoelastic fluid such that a different radial velocity is established between small particles in the sample and large particles in the sample (“bioparticles and cells, focus into streamlines in the same way and in the same locations as in existing inertial and viscoelastic focusing system, page 3, lines 27-30; “FL is strongly correlated with the particle size (a) and flow velocity (Um)”, page 15, lines 31-33; “system was further tested with 3.1, 4.8 and 10 mm particles at varying flow velocities. The flow velocity in the microchannel was adjusted by varying the driving pressure from 1 psi to 25 psi. To keep the Rep within a comparable range for different size particles, the tested pressure range was decreased as the particle size increased.”, page 29, lines 24-28).
With regard to claims 32 and 33, the device as disclosed by Mutlu et al. results in the differential radial velocity resulting in the increased collision frequency (because the particles flow toward the central axis of the tube based on the viscoelastic fluid flow).
Therefore, the invention as claimed is anticipated by Mutlu et al.
Claims 23 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hindson et al. (U.S. Patent No. 10,166,522 B2, issued January 1, 2019).
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With regard to claim 23, Hindson et al. teach a device comprising the below configuration (reproduced from Fig. 4):
As seen, the device configuration shows a first tube (middle section) comprising a first lumen having first proximal and a first distal opening (from left side to the right side, respectively); a second tube (right section) comprising a second lumen having a second proximal and second distal opening (left side to right side, respectively); and a source of a sample suspended in a viscoelastic fluid in fluid communication with the first proximal opening (see reagent and sample which is pumped into the middle channel (or lumen) at the left side (i.e., first proximal opening).
With regard to claim 28, the device configuration shows a receptacle disposed at the end of distal opening (see element 2822 where the products are collected).
Therefore, Hindson et al. discloses the invention as claimed based on the identically claimed structure.
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 28 is rejected under 35 U.S.C. 103 as being unpatentable over Mutlu et al. (WO 2018/223132 A1, published December 2018).
Teachings of Mutlu et al. have been discussed above.
Mutlu et al. do not explicitly teach that a receptacle is disposed at the second distal opening.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Mutlu et al. and arrive at a configuration on which a collection receptacle is disposed onto the device of the artisans for the following reasons.
As already discussed above, Mutlu et al. teach that their device is directed for concentrating a very small particles or cells using a channel(s) via driving pressures (page 12, lines 1-4).
Mutlu et al. also explicitly teach that the device comprises an outlet where the product is directed toward (see also outlet of products on Fig. 5A):
“Focusing of particles into specific streamlines can be used to concentrate focused particles when those streamlines are sorted into a ‘product’ outlet in a fluidic circuit by means of controlled output flows” (page 20, lines 25-26)
The Supreme Court, in KSR (550 U.S. 398, 82 USPQ2d 1385 (2007)) held that obvious to try was a valid rationale so long as there is a design need or finite number of solutions, such motivation being borne of common sense:
“The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.”). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
One of ordinary skill in the art, based on the suggestion made by Mutlu et al. as well as having common sense to collect the product produced in the device of Mutlu et al. in any of finite solutions known in the art, such as a receptacle, a predictable solution
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 October 27, 2025
/YJK/
1 The Office notes that the device as presently does not actively require any sample or the first, second, or third binding partners, but only a structure which can act upon the sample containing the first, second, or third binding partners as recited.
2 The term, “lumen” is defined as “the bore of a tube”, from Merriam-Webster.com: http://merriam-webster.com/dictionary/lumen
3 See Applicants’ device in Fig. 4.