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 .
Status of Claims
Claims 1-5, 8-12 and 16-20 have been amended. Claim 13 has been cancelled. Claims 1-12 and 14-20 are pending and have been examined.
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) 1-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oyamada (US 2009/0111196) as applied to claim 10 above, and further in view of Alsager et al. (US 2016/0257959, Pub Date: 09/08/2016).
Regarding claims 1 and 10, Oyamada teaches throughout the publication an immunochromatography measurement method, comprising measuring an immunochromatography chip (abstract) wherein the measurement is performed by an electron microscope after applying a specimen and an auxiliary liquid other than the specimen to the chip, (paragraphs 0050 and 0106-0107). However, while Oyamada teaches the auxiliary and additional buffers can be used, the reference fails to explicitly teach that the auxiliary liquid consists of and wherein the auxiliary liquid consists of at least one compound selected from the group consisting of glycerin, a glycerin substitute, polysorbates such as polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, and polysorbate 85, and a polysorbate alternative as an essential component; and optionally at least one compound selected from the group consisting of monosaccharides, disaccharides, salts, and buffer solutions and wherein the auxiliary liquid improves a sharpness of images when measuring an immunochromatography chip by an electron microscope.
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).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate as one of the additional auxiliary liquids of Oyamada, a detergent such as Tween 20, Tween 40 or Tween 80, as taught by Alsager because Oyamada is generic regarding the types of buffers used as the auxiliary agent and therefore one having ordinary skill in the art would have been motivated to choose the appropriate buffer based on the desired samples being analyzed. Additionally, Alsager explicitly teaches that the addition of detergents such as Tween 20, Tween 40 or Tween 80 enhance sensitivity during small target molecule detection as the presence of the detergent can affect the charge distribution of the target by removal of weakly bound non-specific targets from the nanoparticle conjugate surface thereby enhancing its conformational energetics (see Alsager, paragraphs 0093-0094).
Regarding claim 2, Oyamada teaches the method wherein the auxiliary liquid is provided with conductivity for preventing charging and heat generation, which contributes to a sharpness of images under measurement conditions by electron microscope (paragraph 0107, electron microscope; Applicant’s specification at paragraph 0062 describes that it is not necessarily clear how the application of the auxiliary liquid improves sharpness of images but inventors believe that irradiation by the electron beam is a contributor – thus irradiation during analysis by electron microscope of Oyamada would also provide the effects recited in the claim).
Regarding claim 3 and claims 11-12, Oyamada in view of Alsager teaches the method wherein the auxiliary liquid has a property of forming a membrane by polymerization under the measurement conditions by electron microscope and has a property of being conductive under measurement conditions by the electron microscope (Alsager, paragraph 0021 – as the detergents of Alsager read on the claimed auxiliary liquids, the detergents of Alsager would inherently have the claimed properties).
Regarding claim 4, Oyamada teaches the method wherein the method is immunochromatography using a labeled antibody supporting metal nanoparticles as a labeling substance (paragraph 0036), and a capture antibody having a property of binding to a complex of the labeled antibody and an object to be detected in the specimen (paragraphs 0049-0050).
Regarding claim 5, Oyamada teaches the method wherein the capture antibody is immobilized on the immunochromatography chip at spatial intervals (paragraph 0111).
Regarding claim 6, Oyamada teaches the method wherein the specimen and the auxiliary liquid are applied simultaneously (paragraph 0113, specimen and buffer applied reads on this limitation as the claim has not defined any parameters or properties of the auxiliary liquid).
Regarding claim 7, Oyamada teaches the method wherein the auxiliary liquid is developed after the specimen has been developed (paragraph 0107).
Regarding claim 8, Oyamada teaches the method wherein the object to be detected is identified by identifying the labeling substance in an electron microscope image (paragraph 0114-0115). Although Oyamada does not specifically teach that artificial intelligence is used to produce the identification of the labeling substance which thus detects the object, as stated in MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In this case, even though the identified label to detect the object was not produced by artificial intelligence, the detected label and object of Oyamada is the same as the claimed invention and thus the claim is found to be unpatentable even though Oyamada was conducted by a different process.
Regarding claim 9, Oyamada teaches the method wherein the object to be detected is identified by identifying the labeling substance in an electron microscope image (paragraph 0114-0115). Although Oyamada does not specifically teach that energy dispersive X-ray spectroscopy is used to produce the identification of the labeling substance which thus detects the object, as stated in MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In this case, even though the identified label to detect the object was not produced by energy dispersive X-ray spectroscopy, the detected label and object of Oyamada is the same as the claimed invention and thus the claim is found to be unpatentable even though Oyamada was conducted by a different process.
Regarding claim 14, Oyamada in view of Alsager teaches an immunochromatography chip to be used in the method according to claim 1, the immunochromatography chip comprising a detection unit dedicated to electron microscope measurement (paragraph 0031-0035 and 0114-0115).
Regarding claim 15, Oyamada teaches the chip wherein a labeled antibody supporting metal nanoparticles (paragraph 0036) as a labeling substance is immobilized at a predetermined position, and a capture antibody having a property of binding to a complex of the labeled antibody and an object to be detected is immobilized on the detection unit dedicated to electron microscope measurement (paragraphs 0049-0050 and 0114-0115).
Regarding claim 16, Oyamada teaches the chip wherein the capture antibody is immobilized at spatial intervals (paragraph 0111).
Regarding claim 17, Oyamada teaches the chip further comprising an additional detection unit for visual observation (paragraphs 0114-0115).
Regarding claim 18, Oyamada teaches the chip wherein the immunochromatography chip does not comprise any additional detection units other than the detection unit dedicated to electron microscope measurement (paragraphs 0114-0115).
Regarding claim 19, Oyamada in view of Alsager teaches an immunochromatography measurement kit comprising the auxiliary liquid according to claim 10 as a constituent component (Oyamada, paragraphs 0112-0115; Alsager, paragraphs 0021 and 0093-0094).
Regarding claim 20, Oyamada teaches an immunochromatography measurement kit (paragraphs 0112-0115) comprising, an auxiliary liquid for immunochromatography measurement (paragraphs 0050 and 0106-0107), and the immunochromatography chip according to claim 14 (paragraphs 0112 and Figure 1). However, while Oyamada teaches the auxiliary and additional buffers can be used, the reference fails to explicitly teach that the auxiliary liquid consists of and wherein the auxiliary liquid consists of at least one compound selected from the group consisting of glycerin, a glycerin substitute, polysorbates such as polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, and polysorbate 85, and a polysorbate alternative as an essential component; and optionally at least one compound selected from the group consisting of monosaccharides, disaccharides, salts, and buffer solutions and wherein the auxiliary liquid improves a sharpness of images when measuring an immunochromatography chip by an electron microscope.
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).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate as one of the additional auxiliary liquids of Oyamada, a detergent such as Tween 20, Tween 40 or Tween 80, as taught by Alsager because Oyamada is generic regarding the types of buffers used as the auxiliary agent and therefore one having ordinary skill in the art would have been motivated to choose the appropriate buffer based on the desired samples being analyzed. Additionally, Alsager explicitly teaches that the addition of detergents such as Tween 20, Tween 40 or Tween 80 enhance sensitivity during small target molecule detection as the presence of the detergent can affect the charge distribution of the target by removal of weakly bound non-specific targets from the nanoparticle conjugate surface thereby enhancing its conformational energetics (see Alsager, paragraphs 0093-0094).
Response to Arguments
Applicant’s arguments filed 11/10/2025 have been considered. Applicant’s arguments are generally drawn to the teachings of Oyamada and its use of silver ions as the amplification solution, that is essential and required in the immunoassay method of the reference. While Examiner agrees that the silver ions/amplification solution is required in the method of Oyamada, the reference also teaches the use of additional buffers. As amended, the claim requires that the auxiliary liquid must only consist of the claimed liquids. However, the claim still recites open “comprising” language in the preamble and thus the claim does not exclude other solutions from being added during the immunochromatography method but instead requires that only the auxiliary liquid itself consist of one of the claimed liquids. Alsager clearly teaches that the use of a detergent such as Tween-20, Tween-40 or Tween-80, within an assay provides advantages to detection such as enhanced sensitivity (see Alsager, paragraphs 0093-0094). The only method step provided in the claim is a measuring step and that is limited to be conducted after applying a specimen and an auxiliary liquid – but other liquids and solutions could still feasibly be added before measurement or even after measurement. Therefore, the teachings of Oyamada that also include silver ion amplification solutions still read on the claimed method in view of the teachings of Alsager, as described 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 REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677