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 .
Election/Restrictions
Applicant’s election without traverse of claims 1, 3, 5-13, and 21-22 in the reply filed on 05 February 2026 is acknowledged.
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 1, 3, and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsuda et al. (“Plasmonic properties of inverted cone shaped plasmonic nanopores”, disclosed in IDS 17 May 2024), hereinafter Matsuda.
Claim 1: Matsuda discloses a generation method for spectral data of a microparticle sample containing a plurality of microparticles, the generation method comprising:
acquiring a measured spectrum from each of the plurality of microparticles by causing the plurality of microparticles to pass through a through-hole of a substrate one by one (“The present study aims to investigate the effects of these molecules on the structure”; 2nd ¶) while applying light into the through-hole (“excitation light was irradiated from below the nanopore structure”, 4th ¶), wherein
the through-hole has a tapered structure in which a width continuously reduces from one surface of the substrate to another surface of the substrate (“the mortar-shaped nanopore structure”, 3rd ¶; evident from Fig. 1),
at least part of an inner surface of the through-hole is made of a metal that exhibits plasmon resonance (“a nanopore structure… with 100 nm thick Au on Si… and the angle (θ) dependence of the plasmonic properties”, 4th ¶), and
the spectral data is a bundle of a plurality of the measured spectra (Fig. 2; well-known to display a representative averaged spectrum for a plurality of measured spectra).
Claim 3: Matsuda further discloses wherein a length of the microparticle ranges from 10 nm to 5 μm (“a nanopore structure with a diameter of 100 nm coated with 100 nm thick Au on Si”, 4th ¶).
Claim 5: Matsuda further discloses wherein the acquiring a measured spectrum includes moving the microparticle, dispersed in a liquid, into the through-hole with one or more methods selected from the group consisting of electrophoresis, dielectrophoresis, optical tweezers, Brownian movement, and Coulomb interaction (“the angle (θ) dependence of the plasmonic properties (enhanced electric field) at the edge, mainly at the bottom of the mortar structure, was evaluated”, 4th ¶).
Claim 6: Matsuda further discloses wherein the measured spectrum is a Raman spectrum (“obtain stronger enhanced Raman scattered light”, 2nd ¶).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Matsuda as applied to claim 1 above, and further in view of Nozawa (US 2024/0219236), hereinafter Nozawa.
Claim 7: Matsuda does not explicitly disclose wherein the measured spectrum is a fluorescent spectrum.
Nozawa, however, in the same field of endeavor of Raman spectroscopy, discloses concurrently generating a Raman spectrum and a fluorescent spectrum (“In the Raman spectroscopy measurement, fluorescent light may be generated from the sample together with the Raman scattered light” [0004]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Matsuda’s generation method to acquire a fluorescent spectrum in addition to the Raman spectrum for the purpose of characterizing the sample with relative independence of the excitation light frequency (Nozawa [0009]).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuda.
Claim 21: Matsuda discloses wherein the through-hole has a tapered structure in the shape of a pyramid frustum (“the mortar-shaped nanopore structure”, 3rd ¶; evident from Fig. 1), but does not explicitly disclose wherein the upper- and lower-side opening portions of the through-hole have a quadrangular shape.
However, Applicant has provided no criticality for the openings to be of this shape, disclosing only that the shape of a quadrangular pyramid frustrum is “particularly preferable” (Spec. Page 36, Line 5). Furthermore, from the through-hole shape disclosed by Matsuda, it is well known that a frustum is either a quadrangular pyramid frustrum or a circular pyramid frustrum, meaning that the upper- and lower-side opening portions are either quadrangular or circular.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the shape of Matsuda’s through-hole so that the upper- and lower-side opening portions are quadrangular for the purpose of using a well-known tapered structure shape. It would be obvious to try based on the finite number of shape choices.
Claim 22: Matsuda discloses wherein the through-hole has a tapered structure in the shape of a pyramid frustum (“the mortar-shaped nanopore structure”, 3rd ¶; evident from Fig. 1), but does not explicitly disclose wherein the shape is of a quadrangular pyramid frustum.
However, Applicant has provided no criticality for this shape, disclosing only that the shape of a quadrangular pyramid frustrum is “particularly preferable” (Spec. Page 36, Line 5). Furthermore, from the through-hole shape disclosed by Matsuda, it is well known that a frustum is either a quadrangular pyramid frustrum or a circular pyramid frustrum.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the shape of Matsuda’s through-hole to be a quadrangular pyramid frustrum for the purpose of using a well-known tapered structure shape. It would be obvious to try based on the finite number of shape choices.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuda as applied to claim 1 above, and further in view of Stockman et al. (US 6,677,160), hereinafter Stockman.
Claims 8-9: Matsuda is silent with respect to an analysis method for a microparticle, comprising making a statistical analysis of the spectral data.
Stockman, however, in the same field of endeavor of spectroscopy, discloses an analysis method for a microparticle, comprising making a statistical analysis of spectra data (Col. 25, Lines 31-33), wherein the making a statistical analysis of the spectral data includes forming a collection of peaks having a high correlation coefficient with each other between the plurality of measured spectra of the spectral data (Col. 25, Lines 33-35), and
identifying at least one component contained in the microparticles by comparing the obtained collection of peaks with a spectrum of a known object (Col. 25, Lines 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the spectral data acquired with Matsuda’s generation method with an analysis method for the purpose of accurately characterizing the properties of the sample.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuda as applied to claim 1 above, and further in view of Xie et al. (US 2021/0372933), hereinafter Xie.
Claims 8,10: Matsuda is silent with respect to an analysis method for a microparticle, comprising making a statistical analysis of the spectral data.
Xie, however, in the same field of endeavor of SERS, discloses an analysis method for a microparticle, comprising making a statistical analysis of spectra data [0053], wherein the making a statistical analysis of the spectral data includes making a multivariate analysis on the plurality of measured spectra of the spectral data (“analysis program 142 that uses… statistical analysis algorithms 143 such as… multivariate analysis” [0053]), and identifying at least one component contained in the microparticles (“performing an algorithm of multivariate analysis such as principle component analysis (PCA) on the spectra” [0053]) by comparing a spectrum, obtained through the multivariate analysis, with a spectrum of a known object (“a structure suitable for comparison with stored vibrational spectra data or Raman shift library data of database 150” [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the spectral data acquired with Matsuda’s generation method with an analysis method for the purpose of accurately characterizing the properties of the sample.
Allowable Subject Matter
Claims 11-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 11-12: None of the prior art, alone or in combination, teaches or discloses a discrimination method of discriminating a yet-to-be discriminated microparticle, the discrimination method comprising:
acquiring a measured spectrum of each of a plurality of microparticles A of which a type has been turned out and a measured spectrum of each of a plurality of microparticles B of which another type has been turned out, with the generation method according to Claim 1;
making a principal component analysis of spectral data including the measured spectra of the plurality of microparticles A and the measured spectra of the plurality of microparticles B and obtaining an index to discriminate the measured spectrum of the microparticle A and the measured spectrum of the microparticle B from scores of two or more principal components;
acquiring a measured spectrum from each of one or more yet-to-be discriminated microparticles in a microparticle sample with the generation method according to Claim 1;
calculating scores of the two or more principal components for the measured spectrum of the yet-to-be discriminated microparticle; and
performing discrimination by comparing the scores of the yet-to-be discriminated microparticle with the index, wherein
a length of the yet-to-be discriminated microparticle ranges from 10 nm to 5 μm.
Claim 13: None of the prior art, alone or in combination, teaches or discloses a determination method of determining presence or absence of a cancer cell-derived exosome in a body fluid-derived sample containing exosomes, the determination method comprising:
generating spectral data made up of a plurality of measured spectra respectively obtained from a plurality of exosomes in the sample with the generation method according to Claim 1;
obtaining a correlation coefficient between a signal having a local maximum at 1087 cm-1 ± 5 cm-1 and a signal having a local maximum at 1435 cm-1 ± 5 cm-1 between the plurality of measured spectra; and
determining that a cancer cell-derived exosome is present in the sample when the correlation coefficient is higher than or equal to a certain value.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to HINA F AYUB whose telephone number is (571)270-3171. The Examiner can normally be reached on 9am-5pm ET Mon-Fri.
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, Tarifur Chowdhury can be reached on 571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/Hina F Ayub/
Primary Patent Examiner
Art Unit 2877