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 .
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.
Priority
This application is a continuation of PCT/JP2020/011491 filed on March 16, 2020, which claims priority to Foreign Application No. 2019-066094 filed on March 29, 2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
The Applicant amended claim 1 and noted that no new matter is added. The Applicant previously presented claims 2-3, 5-6, 10-11, 13-14, 18 and 20. The Applicant cancelled claims 4, 7-9, 12 , 15-17, 19 and 21.
Thus, claims 1-3, 5-6, 10-11, 13-14, 18 and 20 are pending and are under examination.
Withdrawn Objections and Rejections
The previous objection to claim 1, regarding informalities, is withdrawn in light of Applicant’s amendments of the claim.
The previous objection to claim 21, regarding informalities, is withdrawn in light of Applicant’s cancellation of the claim.
The previous rejection of claims 15-17 and 21 under 35 U.S.C. 103, regarding obviousness as being unpatentable over Chiku et al. (US 2011/0269247 A1) in view of Omoto et al. (JP2007205911 A), is withdrawn in light of Applicant’s cancellation of the claims.
Maintained Rejections
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 (PHOSITA) 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.
Claims 1-3, 5-6, 10-11, 13-14, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chiku et al. (US 2011/0269247 A1) in view of Omoto et al. (JP2007205911 A).
Regarding claim 1, Chiku teaches an immunochromatographic method (Page 1, [0002]).
Chiku teaches a mixing step of mixing a specimen that is capable of containing a test substance with a first binding agent (Page 3, [0037] and [0048]).
Chiku teaches a developing step of developing the complex on an insoluble carrier having a reaction site (Page 3, [0033]).
Chiku teaches that the reaction site of the insoluble carrier has an immobilized second binding substance that is capable of binding to the test substance (Page 3, [0037]).
Chiku teaches a capturing step of capturing the complex at the reaction site of the insoluble carrier (Page 3, [0037] and [0048]; page 4, [0061]).
Chiku teaches a silver amplification step of silver-amplifying the complex captured in the capturing step ([0021]; page 3, [0037]).
Chiku teaches that the silver amplification step is a step of silver-amplifying the complex captured in the capturing step, using a reducing agent solution and a silver amplification solution (Page 5, [0037] and [0049]).
Regarding claim 1, Chiku teaches that the developing direction of the reducing agent solution in the silver amplification step is in the same direction of the developing direction of the complex in the developing step as in comparative example 1 and example 1 (Page 21, table, “Amplification direction”, “0 degree”).
Regarding claim 1, Chiku teaches that the developing direction of the silver amplification solution in the silver amplification step is in the opposite direction of the developing direction of the complex in the developing step or 180 degrees (Page 3, [0039] and [0050]; page 18, [0252]; page 19, [0253]).
Regarding claims 10 and 18, Chiku teaches optical detection (Pages 8-10, [0136]).
Regarding claim 1, Chiku does not teach using a modified composite particle.
Chiku does not teach that the composite particle is a composite particle of a magnetic particle and a gold particle carried on a surface of the magnetic particle.
Regarding claim 2, Chiku does not teach that a material of the magnetic particle is iron oxide.
Regarding claims 3 and 11, Chiku does not teach a collection step of collecting the modified composite particle or the complex using magnetism, before the developing step.
Regarding claims 5, 13 and 20 Chiku does not teach that in the composite particle an average particle diameter of the gold particles is smaller than an average particle diameter of the magnetic particles.
Regarding claims 6 and 14, Chiku does not teach that an average particle diameter of the composite particles is 10 nm to 300 nm.
Regarding claims 10 and 18, Chiku does not teach magnetic detection.
Regarding claim 1, Omoto teaches a composite particle (Page 4, [0006]) that is modified with a first binding substance such as an antibody that is capable of binding to the test substance, to obtain a complex of the test substance in the specimen and the modified composite particle (Page 8, [0028]). Omoto teaches that the composite particle is a composite particle of a magnetic particle and a gold particle carried on a surface of the magnetic particle (Page 4, [0006]).
Regarding claim 2, Omoto teaches that a material of the magnetic particle is iron oxide (Page 4, [0006]).
Regarding claims 3 and 11, Omoto teaches a collection step of collecting the modified composite particle or the complex using magnetism, before the developing step (Page 12-13, [0044]).
Regarding claims 5, 13 and 20 Omoto teaches that in the composite particle an average particle diameter of the gold particles is smaller than an average particle diameter of the magnetic particles (Page 5, [0011] and [0013]).
Regarding claims 6 and 14, Omoto teaches that an average particle diameter of the composite particles is 10 nm to 300 nm (Page 5, [0011]).
Regarding claims 10 and 18, Omoto teaches magnetic detection (Page 123, [0042]).
It would have been obvious for a PHOSITA before the effective filing date of the instant application to modify the immunochromatographic method of Chiku with the composite particles of Omoto to improve the detection limit of an analyte by an immunochromatographic method because Chiku noted the need for a rapid and highly specific method for measuring analytes in hospitals and in laboratories (Page 2, [0013]), and Omoto provided a gold/iron oxide composite magnetic particle that is suitably used for immunoassays without applying complicated processes such as cleaning (Abstract). A skilled artisan would be motivated to use a gold/iron oxide composite magnetic particle in an immunochromatographic method because it increases the assay speed by avoiding complicated steps as noted by Omoto (Page 13, [0045]). A PHOSITA would have had a reasonable expectation of success in combining the methods of Chiku with Omoto because the methods are directed to detecting an analyte by an immunoassay. Consequently, it would have been obvious for a PHOSITA to use a gold/iron oxide composite magnetic particle in an immunochromatographic method because of its diagnostic and industrial applicability.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-6, 10-11, 13-14, 18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10- of copending Application No. 17/205,649 in view of Chiku et al. (US 2011/0269247 A1) and Omoto et al. (JP2007205911 A). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1 pertaining to Immunochromatography method comprising a mixing step of mixing a specimen that is capable of containing a test substance with a modified composite particle that is a composite particle modified with a first binding substance that is capable of binding to the test substance, to obtain a complex of the test substance in the specimen and the modified composite particle; a developing step of developing the complex on an insoluble carrier having a reaction site at which a second binding substance capable of binding to the test substance is immobilized; a capturing step of capturing the complex at the reaction site of the insoluble carrier; and a silver amplification step of silver-amplifying the complex captured in the capturing step; wherein the composite particle is a composite particle of a magnetic particle and a gold particle carried on a surface of the magnetic particle; wherein the silver amplification step is a step of silver-amplifying the complex captured in the capturing step, using a reducing agent solution and a silver amplification solution, ‘649 teaches an immunochromatography method comprising mixing a specimen that contains a test substance with a modified composite particle … which is modified with a first binding substance that is capable of binding to the test substance to obtain a complex of the test substance in the specimen and the modified composite particle; collecting, using magnetism, the complex in the specimen obtained after the mixing step; spreading the complex collected in the collection step on an insoluble carrier having a reaction site at which a second binding substance that can bind to the test substance is immobilized; trapping the complex at the reaction site of the insoluble carrier; silver-amplifying the trapped complex subsequent to the trapping step (See claims 10-11 and 17-18 of ‘649).
‘649 teaches that the composite particle is made of a gold particle that is bound to one of the magnetic particles via the organic substance with an average number of less than 10.0 (See claims 12).
Regarding claims 3 and 11 pertaining to the immunochromatography method further comprising a collection step of collecting the modified composite particle or the complex using magnetism, before the developing step, ‘649 teaches collecting, using magnetism, the complex in the specimen obtained after the mixing step (See claims 10 and 17 of ‘649).
Regarding claims 6 and 14 pertaining to wherein an average diameter of the composite particles is 10 nm to 300 nm, ‘649 teaches that the average particle size of at least one of the magnetic particles or the gold particles is less than 300 nm, less than 150 nm or less than 100 nm (See claims 2-4 of ‘649).
Regarding claims 10 and 18 pertaining that both optical detection and magnetic detection are possible, ‘649 teaches magnetic detection (See claims 10-11 and 17-18 of ‘649).
Regarding claim 1, ‘649 does not teach that the silver amplification step uses a reducing agent solution and a silver amplification solution.
Regarding claim 1 pertaining to wherein a developing direction of the reducing agent solution in the silver amplification step is the same direction as a developing direction of the complex in the developing step, ‘649 does not teach that the developing direction of the reducing agent solution in the silver amplification step is in the same direction as a developing direction of the complex in the developing step.
Regarding claim 1 pertaining to wherein a developing direction of the silver amplification solution in the silver amplification step is the direction opposite to a developing direction of the complex in the developing step, ‘649 does not teach that the developing direction of the silver amplification solution in the silver amplification step is in the opposite direction of the developing direction of the complex in the developing step.
Regarding claim 2 pertaining to that the material of the magnetic particle is iron oxide, ‘649 does not teach that the material of the magnetic particle is iron oxide.
Regarding claim 5, 13 and 20 pertaining to that in the composite particle, an average particle diameter of the gold particles is smaller than an average particle diameter of the magnetic particles, ‘649 does not teach that in the composite particle, an average particle diameter of the gold particles is smaller than an average particle diameter of the magnetic particles.
Regarding claims 10 and 18 pertaining to that both optical detection and magnetic detection are possible ‘649 does not teach optical detection.
Regarding claim 1 Chiku teaches that the silver amplification step is a step of silver-amplifying the complex captured in the capturing step, using a reducing agent solution and a silver amplification solution (Page 5, [0037] and [0049]).
Regarding claim 1, Chiku teaches that the developing direction of the reducing agent solution in the silver amplification step is in the same direction of the developing direction of the complex in the developing step as in comparative example 1 and example 1 (Page 21, table, “Amplification direction”, “0 degree”).
Regarding claim 1, Chiku teaches that the developing direction of the silver amplification solution in the silver amplification step is in the opposite direction of the developing direction of the complex in the developing step or 180 degrees (Page 3, [0039] and [0050]; page 18, [180]; page 19, [0253]).
Regarding claims 10 and 18, Chiku teaches optical detection (Pages 8-10, [0136]).
Regarding claim 2, Omoto teaches that a material of the magnetic particle is iron oxide (Page 4, [0006]).
Regarding claims 5, 13 and 20 Omoto teaches that in the composite particle an average particle diameter of the gold particles is smaller than an average particle diameter of the magnetic particles (Page 5, [0011] and [0013]).
It would have been obvious to one of ordinary skill in the art before the filing date of the application to combine the optical detection of Chiku with the immunochromatography method of ‘649 because Chiku noted the need for a rapid and highly specific method for measuring analytes in hospitals and in laboratories (Page 2, [0013]). The ordinary artisan is motivated to combine the composite particles of Omoto with the methods of Chiku and ‘649 because Omoto provided a gold/iron oxide composite magnetic particle that can be suitably used for immunoassays without applying complicated processes such as cleaning (Abstract). The ordinary artisan is motivated to use a gold/iron oxide composite magnetic particle in an immunochromatographic method because it can increase the assay speed by avoiding complicated steps as noted by Omoto (Page 13, [0045]). Therefore, such combinations would be considered an advantageous additives to ‘649 which also recognizes a need for improving measurements.
Response to Arguments
Applicant's arguments filed 03/20/2026 have been fully considered but they are not persuasive for the reasons set forth in the previous Office Action dated 12/23/2025 on pages 13-15.
The Applicant still argued that Reference Chiku et al. combined with Omoto fail to disclose or suggest (i) a developing direction of the reducing agent solution in the silver amplification step being the same direction as a developing direction of the complex in the developing step and (ii) a developing direction of the silver amplification solution in the silver amplification step being the direction opposite to a developing direction of the complex in the developing step
Briefly, Chiku teaches that the silver amplification step is with reducing agent and with silver-containing compound (Page 4, [0070]) and further teaches that the washing solution contains a reducing agent for silver or a compound containing silver (Page 4, [0072]). Chiku teaches the amplification step from different angles and compare to 0-degrees amplification direction.
Furthermore, the instant case is a clear example of routine optimization within the prior art conditions or through routine experimentation. In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017) ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … ."). In the instant case,
Chiku teaches that the developing direction of the reducing agent solution in the silver amplification step is in the same direction of the developing direction of the complex in the developing step as in comparative example (Page 17, “Amplification from 0-Degree Direction; page 21, table 1, “Amplification direction”, “0 degree”). Chiku also teaches that the developing direction of the silver amplification solution in the silver amplification step is in the opposite direction of the developing direction of the complex in the developing step or 180 degrees (Page 3, [0039] and [0050]; page 18, [180]; page 19, [0253]). Chiku teaches that the angles are modified to test different conditions. Chiku teaches the example of amplification from 0-Degree as a comparative example to which other angles are compared to (Page 17, “Comparative Example 1”). Chiku teaches that each development is optimized by having different material, form and volume (Page, [0099]).
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the instant case, Chiku teaches multiple examples for amplification from different angles (Page 21, Table1, “Amplification direction”). Also, Chiku teaches the amplification from 0-degrees example as a comparative example to which all amplifications from different angles are compared to and washings compared to as well (Page 17, Comparative Example 1; page 28, [0301]).
Thus, the previous rejection of claims 1-3, 5-6, 10-11, 13-14, 18 and 20 under 35 U.S.C. 103 is still maintained and is made final.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 OMAR RAMADAN whose telephone number is (571)270-0754. The examiner can normally be reached Monday-Friday 8:30 am - 5:00 pm.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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