DETAILED ACTION
The finality of the last Office action is withdrawn, and new grounds of rejection are set forth below.
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 2 and 8 are cancelled.
Claims 1, 3-7, and 9-10 are pending in this application and have been examined.
Withdrawn Rejections
The rejection of claims 1, 3-7, and 9-10 on the grounds of 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Newton (US 20060205090 A1, published 2006-09-14, cited in PTO-892 dated 2025-05-02) has been withdrawn, necessitated by arguments filed 2026-02-13. The office agrees with the applicant’s argument that the 2 x 106 Da dextran molecule of Newton (cited below) does not necessarily have size equal to 54 nm as disclosed by Manninen (cited below), therefore, the inherency argument is insufficient.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: the claims recite “an average particle size of a complex of the labeling substance and the water-soluble carrier, exclusive of the antibody, is 50 to 135 nm”. The claim should recite, “ the average size of a complex of the labeling substance and the water-soluble carrier, exclusive of the antibody, is 50 to 135 nm”. Appropriate correction is required.
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.
Claims 1, 3-7, and 9-10 are newly rejected under 35 U.S.C. 103 as being unpatentable over Newton (US 20060205090 A1, published 2006-09-14, cited PTO-892 dated 2025-05-02) and Zhan, et al. (“The Role of Nanoparticle Design in Determining Analytical Performance of Lateral Flow Immunoassays”, published 2017-11-09) as evidenced by Manninen et al. (“THE SWELLING AND PORE STRUCTURE OF MICROFIBRILLATED CELLULOSE”, published 2013, cited in PTO-892 dated 2025-05-02), Ivanov, et al. (“Registration of Functioning of a Single Horseradish Peroxidase Macromolecule with a Solid-State Nanopore”, published 2023, cited in PTO-892 dated 2025-11-14), and Huhn, et al. (“The molecular reach of antibodies crucially underpins their viral neutralisation capacity”, published 2025-01-02).
Newton teaches an immunochromatographic strip for use in detecting a test substance in a sample comprising a labeled-body section with an antibody (specific to the test substance) immobilized on a water-soluble carrier made of a water-soluble polymer, as in claim 1 (see, e.g., immunochromatographic strip for use in detecting a test substance in a sample – front page, under “ABSTRACT”; antibody immobilized on a water-soluble carrier made of a water-soluble polymer – para. [0135]; labeled-body section – para. [0136]). The examiner understands dextran to be a water-soluble polymer. Newton teaches a labeling substance is immobilized on the water-soluble carrier through a covalent bond and the labeling substance is an enzyme, such as horseradish peroxidase (see, e.g., labeling substance immobilized with covalent bond – para. [0008] and [0011]; labeling substance is an enzyme – para. [0073]: “Examples of enzymes that can be used in the present invention include alkaline phosphatase, horseradish peroxidase, glucose 6-phosphate dehydrogenase, acetylcholinesterase, galactosidase, glucose oxidase, catalase, and choline oxidase”). Ivanov provides evidence that the size of horseradish peroxidase is approximately 4.3 × 4.8 × 5.8 nm (see, e.g., p. 2, under “2. Results”, under “2.1. Nanopore Fabrication”, para. 1).
Newton teaches the water-soluble polymer is a sugar, as in claim 3 (see, e.g., para. [0135]).
Newton teaches a capturing body-immobilized section on which a capturing body capable of capturing the test substance bound to the labeled antibody is immobilized, as in claim 4 (see, e.g., para. [0138]).
Newton teaches an immunochromatographic device based on the immunochromatographic strip of claim 1, as in claim 5 (see, e.g., front page, under “ABSTRACT”).
Newton teaches an immunochromatographic kit consisting of the immunochromatographic strip of claim 1, as in claim 6 (see, e.g., front page, under “ABSTRACT”). Newton teaches everything after the word “comprising”. Thus, Newton anticipates the kit even though it does not explicitly recite the word “kit”.
Newton teaches a method for detecting a test substance in a sample by immunochromatography comprising an immunochromatographic strip comprising a labeled body-containing section with an antibody (specific to the test substance) immobilized on a water-soluble carrier made of a water-soluble polymer, as in claim 7 (see, e.g., immunochromatographic strip for use in detecting a test substance in a sample – front page, under “ABSTRACT”; antibody immobilized on a water-soluble carrier made of a water soluble polymer – para. [0135]; labeled-body section – 15, para. [0136]). Also, Newton teaches a labeling step of bringing a sample and the labeled antibody into contact to form a complex, as in claim 7 (see, e.g., para. [0138]). Furthermore, Newton teaches a capturing step of capturing the complex and a detection step of detecting the complex, as in claim 7 (see, e.g., capturing step - para. [0138]; detecting step - para. [0139]). Newton teaches a labeling substance is immobilized on the water-soluble carrier through a covalent bond and the labeling substance is an enzyme, such as horseradish peroxidase, as in claim 7 (see, e.g., labeling substance immobilized with covalent bond – para. [0008]; labeling substance is an enzyme – para. [0073]: “Examples of enzymes that can be used in the present invention include alkaline phosphatase, horseradish peroxidase, glucose 6-phosphate dehydrogenase, acetylcholinesterase, galactosidase, glucose oxidase, catalase, and choline oxidase”).
Newton teaches the water-soluble polymer is a sugar, as in claim 9 (see, e.g., para. [0135]).
Newton teaches the immunochromatographic strip comprises a capturing body-immobilized section on which a capturing body capable of capturing the test substance bound to the labeled antibody is immobilized, as in claim 10 (see, e.g., para. [0138]). Also, Newton teaches the capturing step comprises capturing the test substance bound to the labeled antibody in the capturing body-immobilized section, as in claim 10 (see, e.g., para. [0138]).
With regards to the particle size limitations of claims 1 and 7, Newton discloses that the water-soluble polymer, dextran, in the molecular weight ranges from 20,000 to 2,000,000 Da (see, e.g., para. [0047]). It is understood that the particles with 2,000,000 Da dextran can be at least 50 nm as evidenced by Manninen, who teaches a 2,000,000 Da dextran molecule can have a spherical diameter in solution of about 54 nm (see, e.g., p. 766, para. 3).
Newton fails to explicitly disclose the average particle size of the complex of labeling substance and water-soluble carrier is 50 to 135 nm, as in claims 1 and 7.
Zhan teaches nanoparticles for immunochromatographic strips with size in the range of 50 to 135 nm, as in claims 1 and 7 (see, e.g., p. 7208, under “Figure 1.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed particle size was anything other than routine, that the properties of the particle size from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. As discussed above, Netwon as evidenced by Manninen discloses a dextran polymer that potentially has a spherical diameter of about 54 nm, while Ivanov discloses the labeling substance is 4.3 × 4.8 × 5.8 nm. Together the polymer and the labeling substance, the enzyme horseradish peroxidase, can be approximately 60 nm. The artisan would have been motivated to optimize the size of the particles into the range of 50 to 135 nm because Zhan discloses, “Comparison of 30, 60, and 100 nm diameter GNPs indicates 100 nm GNPs can improve LFA sensitivity due to higher reaction rate and signal per GNP” (see p. 7208, under the caption of “Figure 1.”). Claims 1 and 7 are limited to particles sizes exclusive of the antibody, while Zhan’s particle sizes are given inclusive of the antibody. Huhn provides evidence that the physical size of antibodies is about 15 nm (see, e.g., p. 1, under abstract). Therefore, it is understood that antibodies covering a nanoparticle would add about 30 nm to the nanoparticle, therefore, the 100 nm nanoparticle of Zhan would be about 70 nm. While Zhan is discussing gold nanoparticles, an artisan would have understood that the particles of Newton would also have a higher reaction rate and signal per particle when the particle size is brought to 100 nm. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Newton and Zhan.
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, 3-7, 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11988666 (referred to as ‘666 hereto) in view of Newton (US 20060205090 A1, published 2006-09-14, cited PTO-892 dated 2025-05-02) and Zhan, et al. (“The Role of Nanoparticle Design in Determining Analytical Performance of Lateral Flow Immunoassays”, published 2017-11-09) as evidenced by Manninen et al. (“THE SWELLING AND PORE STRUCTURE OF MICROFIBRILLATED CELLULOSE”, published 2013, cited PTO-892 dated 2025-05-02), Ivanov, et al. (“Registration of Functioning of a Single Horseradish Peroxidase Macromolecule with a Solid-State Nanopore”, published 2023, cited in PTO-892 dated 2025-11-14), and Huhn, et al. (“The molecular reach of antibodies crucially underpins their viral neutralisation capacity”, published 2025-01-02).
‘666 teaches a blocked labeled lectin with a labeling substance, a lectin, and a water-soluble carrier having an average molecular weight of 200,000 or more, as in claims 1 and 7 (see, claim 1 of ‘666).
’666 teaches the water-soluble carrier is dextran, as in claims 3 and 9 (see, claim 5 of ‘666).
‘666 fails to teach the binding agent is an antibody, as in claims 1 and 7. However, Newton teaches a labeled antibody with a labeling substance, an antibody, and a water-soluble carrier. It would have been prima facie obvious to substitute one binding agent for another. ’666 fails to teach the blocked labeled lectin is used in a immunochromatographic strip, as in claims 1, 4-7, and 10. However, Newton teaches an immunochromatographic strip for use in detecting a test substance in a sample comprising a labeled-body section with an antibody (specific to the test substance) immobilized on a water-soluble carrier made of a water-soluble polymer, as in claim 1 (see, e.g., immunochromatographic strip for use in detecting a test substance in a sample – front page, under “ABSTRACT”; antibody immobilized on a water-soluble carrier made of a water-soluble polymer – para. [0135]; labeled-body section – para. [0136]).
’666 and Newton are analogous to the field of the claimed invention because they are both in the field of water-soluble conjugates. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the product of ‘666 in the immunochromatographic strip of Newton. An artisan would have been motivated to do so because Newton discloses that the conjugates are useful in lateral flow assays (see, e.g., para. [0007]). An artisan would have had a reasonable expectation of success based on the given disclosures.
With regards to the particle size limitations of claims 1 and 7, ’666 discloses that the water-soluble polymer, dextran, in the molecular weight ranges from 200,000 or more (see, claim 5 of ‘666). It is understood that the particles with 2,000,000 Da dextran can be at least 50 nm as evidenced by Manninen, who teaches a 2,000,000 Da dextran molecule can have a spherical diameter in solution of about 54 nm (see, e.g., p. 766, para. 3). Ivanov provides evidence that the size of horseradish peroxidase is approximately 4.3 × 4.8 × 5.8 nm (see, e.g., p. 2, under “2. Results”, under “2.1. Nanopore Fabrication”, para. 1). Together the polymer and the labeling substance, the enzyme horseradish peroxidase, can be approximately 60 nm. But, ‘666 fails to explicitly disclose the average particle size of the complex of labeling substance and water-soluble carrier is 50 to 135 nm, as in claims 1 and 7. However, in a journal article on nanoparticle design for performance of lateral flow assays, Zhan rectifies this deficiency. Zhan teaches nanoparticles for immunochromatographic strips with size in the range of 50 to 135 nm, as in claims 1 and 7 (see, e.g., p. 7208, under “Figure 1.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed particle size was anything other than routine, that the properties of the particle size from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have been motivated to optimize the size of the particles into the range of 50 to 135 nm because Zhan discloses, “Comparison of 30, 60, and 100 nm diameter GNPs indicates 100 nm GNPs can improve LFA sensitivity due to higher reaction rate and signal per GNP” (see p. 7208, under the caption of “Figure 1.”). Huhn provides evidence that the physical size of antibodies is about 15 nm (see, e.g., p. 1, under abstract). Therefore, it is understood that antibodies covering a nanoparticle would add about 30 nm to the nanoparticle, therefore, the 100 nm nanoparticle of Zhan would be about 70 nm, excluding the antibodies. While Zhan is discussing gold nanoparticles, an artisan would have understood that the particles of ‘666 would also have a higher reaction rate and signal per particle when the particle size is brought to 100 nm. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of ‘666 and Zhan.
Response to Arguments
The applicant argues that complexes with the same molecular weight can have different average particle sizes. The applicant continues by citing the following:
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The office agrees with the applicant’s arguments and has withdrawn the 35 U.S.C. 102(a)(1) and 102(a)(2) rejections in response.
The applicant continues by arguing that Newton (cited above), Manninen (cited above), and Ivanov (cited above) do not suggest the concept of the average particle size for the “label carrier”. However, Newton teaches the label carrier of dextran with corresponding molecular weight ranges and Manninen specifies the physical size of a dextran molecule.
The applicant also argues that the references above do not teach or suggest the relationship between the average particle size of the label carrier and sensitivity. The claims as written do not include a relationship between the average particle size of the label carrier and sensitivity, therefore, for claims to be rendered obvious, that relationship does not have to be disclosed. While the withdrawn 35 U.S.C. 102(a)(1) and 102(a)(2) rejection for inherency did not anticipate every element of the claims as written, the new 35 U.S.C. 103 rejection discussed above renders obvious all of the limitations of the claims under examination.
Conclusion
No claims are allowed.
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/MICHAEL CAMERON SVEIVEN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678