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
Applicant’s response filed August 19, 2025 is acknowledged. Claims 1 and 5-7 are amended. Claims 1-10 are pending and further considered on the merits.
Response to Amendment
In light of applicant’s amendment, the examiner withdraws the 35 U.S.C. 112 second paragraph rejections and maintains all other rejections set forth in the office action filed May 23, 2025.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 3-10 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Walker et al., US 2004/0142463 (Walker).
Regarding claim 1, Walker discloses a chip for isolating red blood cells from a whole blood (abstract, figs. 1-5) comprising:
An accommodating space (REF 4) configured for containing a whole blood sample including red blood cell debris;
A porous membrane (REF 3, fig. 5, ¶ 0023), disposed at a bottom of the accommodating space (fig. 5) and comprising a plurality of pores (REF 2, figs. 1-2, ¶ 0020-0021) having a diameter capable of allowing cellular debris to pass therethrough and prevent white blood cells, and circulating tumor cells from passing through (¶ 0129); and
A microchannel system, comprising a liquid inlet (proximate to REF 6, fig. 5), a liquid outlet (proximate to REF 7, fig. 5), and a microchannel (channel connecting REF 5 and REF 7), wherein the microchannel is disposed between and communicates with the liquid inlet and the liquid outlet (fig. 5), the microchannel disposed beneath the porous membrane (fig. 5), and capable of passing a washing liquid therethrough (¶ 0023).
Limitations regarding “a washing liquid introducing into the microchannel through the liquid inlet flows horizontally and directly under the porous membrane” are not considered to provide patentable weight to the claim since said limitation does not provide additional structure beyond what is already recited in the claim. Furthermore, elements of the claim are capable and configured to pass fluids therethrough (see liquid inlet, outlet, and microchannel provided above), where the composition of the fluid is not considered when determining patentability unless explicitly stated as part of the device or system (MPEP 2115).
Regarding claims 3-4, Walker discloses a chip wherein the pores of the membrane are regularly arranged (figs. 1-2) and have a diameter of less than 8 microns (¶ 0129).
Regarding claim 5, Walker discloses a chip wherein a liquid flowing through the microchannel generates a vertical flow field (i.e. via gravity, fig. 5), and the vertical flow field drives material to penetrate through the porous membrane into the microchannel. Additional limitations regarding an action/direction of fluid during operation of the chip are considered only so much as they inform structure of said chip. In this case, the function provided in claim 5 is met by elements recited above (see liquid inlet, liquid outlet, porous membrane, and microchannel described above).
Regarding claim 6, Walker discloses a chip wherein the microchannel system further comprises a pump (see “syringe pump”, ¶ 0023), and the vertical flow field is generated by causing a flow rate difference between a liquid entering the liquid inlet and the liquid exiting the liquid outlet through the pump. Additional limitations regarding an action/direction of fluid during operation of the chip are considered only so much as they inform structure of said chip. In this case, the function provided in claim 6 is met by elements recited above (see liquid inlet, liquid outlet, porous membrane, and microchannel described above).
Regarding claim 7, Walker discloses a method for isolating red blood cells from whole blood comprising:
Providing the chip recited above;
Mixing a blood sample with a red blood cell lysing solution (¶ 0206-0207);
Dropping the blood sample including red blood cell debris into the accommodating space of the chip (¶ 0265); and
Providing a washing liquid to the microchannel system of the chip (¶ 0202), so that a flow rate difference between the washing liquid entering the liquid inlet and the washing liquid exiting the liquid outlet is generated, and the flow rate difference drives the red blood cell debris in the blood sample to penetrate through the porous membrane into the microchannel (¶ 0202, 0265).
Regarding claim 8, Walker discloses a method wherein the flow rate difference between the washing liquid entering the liquid inlet and the washing liquid exiting the liquid outlet is greater than or equal to 50 ml/hour (¶ 0199, 0471, 0530).
Regarding claim 9, Walker discloses a method wherein the diameter of the pores of the porous membrane is less than 8 microns (¶ 0129).
Regarding claim 10, Walker discloses a method wherein after driving red blood cell debris in the blood sample to penetrate through the porous membrane into the microchannel, white blood cells and circulating tumor cells are retained on the porous membrane of the accommodating space (¶ 0169, 0194).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Suzuki et al., US 2020/0362294 (Suzuki).
Regarding claim 2, Walker does not disclose the porous membrane being formed from polyethylene terephthalate. However, Suzuki discloses that it is common to utilize polyethylene terephthalate in membranes intended for particle isolation and separation (abstract, fig. 1, ¶ 0071).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the chip of Walker to include a polyethylene terephthalate material in the porous membrane as described in Suzuki since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for an intended use as a matter of obvious design choice (MPEP 2144.07).
Response to Arguments
Applicant's arguments filed August 19, 2025 have been fully considered but they are not persuasive.
Applicant’s argument regarding the microchannel of Walker is not found persuasive. The microchannel system of Walker provides liquid flow from REF 10 to REF 7 in a vertical direction (via gravity) whereupon encountering the porous membrane (REF 3) said liquid “flows horizontally” and flows “directly under the porous membrane” after encountering the porous membrane (REF 3). The examiner recommends applicant provide further specificity with respect to the structural elements of the claim rather than describe the action of liquid travelling through a fluidic system. Amended elements in claim 1 are considered to be purely functional without any structural counterpart providing a patentable difference between the claims and prior art (as seen in the rejections above).
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 DIRK R BASS whose telephone number is (571)270-7370. The examiner can normally be reached 8-4:30 EST Monday-Friday.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/Primary Examiner, Art Unit 1779