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
Status of Claims
Claims 1-10 are pending and have been examined.
Priority
This application, Serial No. 18/232,724 (PGPub: US2024/0077479) was filed 08/10/2023. This application claims priority to foreign application Taiwan 111133264 filed 09/01/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)- (d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statements
The Information Disclosure Statement filed 08/10/2023 has been considered by the Examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 should remove the word “the” before “applying a magnetic field” at line 4.
Appropriate correction is required.
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 3 and 5 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 3, the claim recites “the contrast” at line 3 and there is no antecedent basis for this limitation.
Regarding claim 5, the claim recites “the pipe” at line 1 and there is no antecedent basis for this limitation.
Claim Rejections - 35 USC § 103
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 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) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (US 2020/0166440, Pub Date: 05/28/2020) in view of Hartman (US 2009/0109441, Pub Date: 04/30/2009).
Regarding claims 1 and 7, Su teaches throughout the publication a detection system and method for a migrating cell (paragraph 0048), suitable for detecting a labeled sample, the labeled sample comprising a migrating cell and an immunomagnetic bead combined with the migrating cell, the immunomagnetic bead comprising a magnetic bead and an antibody embedded into the surface of the magnetic bead, the antibody being combined with an analyte (paragraph 0019 and 0025-0026), and the detection system (see Figure 1) for the migrating cell comprising:
a platform (paragraph 0102);
a microchannel, provided on the platform, and configured to allow the labeled sample to flow in it along a flow direction (paragraphs 0138 and 0140);
a magnetic field source, provided outside the microchannel, and configured to provide a magnetic field to the microchannel, and the magnetic field applying a magnetic force to the magnetic bead of the labeled sample, and the magnetic force comprising at least one magnetic force component and the magnetic force component being opposite to the flow direction (paragraphs 0043-0045 and 0139);
a coherent light source, provided above the platform, and configured to apply coherent light to the microchannel (paragraph 0023, laser); and
an optical sensing module, provided above the platform (paragraph 0023, CCD sensing element).
While Su teaches the use of antibody binding agents on the magnetic particle (paragraphs 0025-0026), a generic list of analytes that can be bound (paragraph 0085) and generic components for the optical detection system (paragraph 0023, CCD sensing element), the reference fails to specifically teach that the analyte is a surface antigen of the migrating cell and that the optical sensing module is configured to receive interference light caused by the coherent light being reflected by the labeled sample inside the microchannel.
Hartman teaches throughout the publication a biosensing detection system (abstract). More specifically, Hartman teaches cell surface targets can be captured using antigen-antibody binding (paragraphs 0011 and 0027). Furthermore, Hartman includes a detection system incorporating a laser and camera (paragraph 0026) wherein the lasers have coherent light and interference patterns are produced and detected by the CCD camera (paragraph 0026).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the analyte of Su to include a cell surface target such as an antigen as taught by Hartman because Su is generic regarding the type of analyte that can be detected with the system and one skilled in the art would be motivated to choose the appropriate analyte based on the desired diagnostics. Additionally, one would be motivated to incorporate with the laser and CCD of Su, functionality to allow the coherent light to produce interference patterns to be detected by CCD camera as taught by Hartman because it would have been desirable to qualitatively and quantitatively analyze the detected analytes since interference patterns can indicate both the presence and the quantity of material bound (Hartman, paragraph 0005).
Regarding claim 2, Su teaches the system wherein the magnetic field source is a coil, and the coil surrounds the microchannel and is configured to provide the magnetic field (paragraph 0045).
Regarding claims 3-4, Su in view of Hartman teaches the system further comprising an image processing module (Su, paragraph 0023, central processing unit), wherein the system electronics can sense the testing environment and direct actuators to respond by moving and pumping and controlling fluidic zones (Su, paragraph 0103). While the references do not explicitly teach that the image processing module calculating the flow velocity of the labeled sample in the microchannel according to the contrast of the interference light, and judging that the migrating cell passes through the microchannel when the value of the flow velocity produces a surge change and that the image processing module calculates the flow velocity of the labeled sample in the microchannel according to the claimed formula: wherein V is flow velocity, T is exposure time, K is contrast, and i and j are pixel coordinates, this limitation is drawn to intended use of the image processing module and therefore the prior art only needs to be capable of performing the claimed intended use. So long as the prior art is capable of performing the claimed intended use, it reads on the claims. Su in view of Hartman teach the same structural components required by the claim of an image processing module, therefore it is considered capable of performing the same intended use.
Regarding claim 5, Su teaches that the fluidic zone has at least one dimension in the micrometer scale but does not specifically teach that the pipe diameter of the microchannel is greater than or equal to 10 micrometer and less than or equal to 50 nanometer. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 5 are for any particular purpose or solve any stated problem, and the prior art teaches that dimensions may vary depending on the desired configuration of the channel for fluid communication of the desired sample (Su, paragraphs 0049-0051). Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the microfluidic art.
Regarding claim 6, while Su in view of Hartman teach that the coherent light source can be a laser (Su, paragraph 0023; Hartman, paragraph 0026), the references fail to specifically teach that the wavelength of the coherent light is greater than or equal to 650 nm and less than or equal to 720 nm. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 6 are for any particular purpose or solve any stated problem, and the prior art teaches that wavelength can be varied based on the type of label used (Su, paragraph 0035). Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the optical detection art.
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (US 2020/0166440, Pub Date: 05/28/2020) in view of Hartman (US 2009/0109441, Pub Date: 04/30/2009), as applied to claim 7 above (hereinafter “Modified Su”) and further in view of Liu et al. (US 2021/0001339, Pub Date: 01/07/2021).
Regarding claim 8, Modified Su teaches the method as described above but fails to teach that after mixing the blood sample with the immunomagnetic bead, further comprising: centrifugally separating and removing the immunomagnetic bead not combined with the migrating cell. Liu teaches throughout the publication a system and method for detection of cells (abstract). More specifically, Liu teaches that in order to reduce the amount of unbound beads in the fluid, centrifugal force can be applied to separate the free beads from other particles in the fluid (paragraph 0083). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Modified Su with the centrifugal separation of unbound beads as taught by Liu because it would have been desirable to separate free beads from other beads in the fluid for further analysis.
Regarding claim 9, Modified Su teaches the method such that after the receiving the interference light caused by the coherent light being reflected by the labeled sample inside the microchannel, further comprising: the applying a magnetic field to the microchannel to drain the labeled sample, and collecting the migrating cell combined with the immunomagnetic bead and attracted by the magnetic field (Su, paragraph 0034, bound cell/particle complex is activated by the magnetic field and drained to the detection zone).
Regarding claim 10, Modified Su teaches the method as described above wherein generic analytes can be detected such as cells, however the references do not specifically teach that the migrating cell is a circulating tumor cell, and an antibody of the immunomagnetic bead is an EpCAM antibody or Her2 antibody. Liu teaches that target cells such as circulating tumor cells are desirable to be detected (abstract). More specifically, Liu teaches that beads conjugated to anti-EPCAM antibodies can be utilized for reactions (paragraph 0186). It would have been prima facie obvious to one having ordinary skill in the art to incorporate as the analyte and bound antibody in the method of Modified Su, EpCAM antibody for the detection of circulating tumor cells as taught by Liu because Modified Su is generic regarding the analyte and binding agent that can be conjugated to the particle and one skilled in the art would have been motivated to choose the appropriate binding agent for detection of the desired target analyte.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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, Bao-Thuy L Nguyen can be reached at 571-272-0824. 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.
/REBECCA M GIERE/Primary Examiner, Art Unit 1677