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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/18/2026 has been entered.
Status of Claims
Claims 1-12 and 19-26 are pending. Claims 1, 6-7 and 19-20 have been amended. Claims 21-26 have been added. Claims 1-5, 8-12 and 16-20 have been amended. Claim 13 has been cancelled. Claims 1-12 and 19-26 have been examined.
Allowable Subject Matter
Claims 1-9 are allowed.
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 20-26 are 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.
Claim 20 is indefinite because it recites a detection unit dedicated to electron microscope measurement but does not disclose any corresponding structure that allows the detection unit to be capable of electron microscope measurement.
Claim 20 is confusing because it recites an immunochromatography chip comprising a detection unit and the metes and bounds of the chip vs the detection unit are unclear. For example, is the immunochromatography chip the detection unit? Or alternatively, is there a chip component that is provided with a separate detection unit?
Claim 21 is similarly confusing because without clear distinction between the structure of the detection unit and immunochromatography chip, it is unclear where exactly the labeled antibody and capture antibody are immobilized.
Claim 23 is indefinite because it recites a detection unit for visual observation but does not disclose any corresponding structure that allows the detection unit to be capable of electron microscope measurement.
Claim 25 is indefinite because it recites a detection unit dedicated to electron microscope measurement but does not disclose any corresponding structure that allows the detection unit to be capable of electron microscope measurement.
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.
Claim(s) 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alsager et al. (US 2016/0257959, Pub Date: 09/08/2016).
Regarding claims 10-12, Alsager teaches methods for the detection of small molecules in samples (abstract). More specifically, Alsager teaches that when contacting the sample with the nanoparticle binding conjugate, the contacting also includes the use of a non-ionic detergent selected from Tween 20, Tween 40 or Tween 80 (paragraph 0021). Alsager also teaches that the inventors have also surprisingly found that detergents and surfactants at an appropriate concentration level can be used in order to achieve enhanced sensitivity towards small target molecules (paragraph 0093).
Regarding claims 10-12, Examiner would like to note that giving the claims their broadest reasonable interpretation, the claims are drawn to a liquid consisting of at least one compound selected from the group consisting of glycerin, a glycerin substitute, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 85, and a polysorbate alternative; and optionally at least one compound selected from the group consisting of monosaccharides, disaccharides, salts, and buffer solutions. As such, the functional limitations of claims 10-12 reciting functions of the liquid are drawn to intended use of the liquid. So long as the non-ionic detergent of Alsager is capable of improving sharpness, being conductive under measurement conditions and forming a membrane by polymerization under measurement conditions, it reads on the claim. Alsager teaches the same non-ionic detergents as claimed and thus they would be seen as capable of performing the same intended uses present in the claims.
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(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Alsager et al. (US 2016/0257959, Pub Date: 09/08/2016), as applied to claim 10 above, and further in view of Harris (US 2008/0206889).
Alsager teaches the liquid as described above but fails to specifically teach that a kit consisting essentially of the liquid. Harris teaches throughout the publication solid phase assay apparatus (abstract) and more specifically teaches the use of nonionic detergent, more specifically a surfactant tool kit commonly available that can include Tween 20 or Tween 80 (paragraph 0042).
It would have been prima facie to one having ordinary skill in the art at the time the invention was filed to provide the auxiliary liquid of Alsager within a surfactant kit as taught by Harris because it would have been desirable to have the liquid readily available and accessible for use in assays.
Response to Arguments
Applicant’s arguments filed 05/18/2026 have been considered. Applicant’s arguments regarding the methods and kit of claims 1-9 and 20-26 have been considered and found to be persuasive. Prior art rejections over these claims have been withdrawn.
However, given the broadness of claims 10-12 and 19 being essentially drawn to a liquid consisting of at least one of the claimed materials, the claims remain unpatentable as described above.
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
Prosecution Insights