DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application was filed 08/15/2024 and is a continuation of 16549387, filed 08/23/2019 which is a continuation of 13819398 filed 05/09/2013 which is a national stage entry of PCT/JP2011/069734 with and international filing date: 08/31/2011and claims foreign priority to JP2010-193213, filed 08/31/2010. There is no English translation of the priority document in the instant file wrapper.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/15/2024 is being considered by the examiner.
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 1-4 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 1 recites, “wherein the sample comprises FGF-23 in a concentration ranging from 1,000 pg/mL to 10,000 pg/mL.” However, the preamble recites, “A method for measuring fibroblast growth factor-23 (hereinafter indicated as FGF-23) in a sample.” Thus the metes and bounds are confusing and unclear as the wherein clause appears to require a specific range of FGF-23 concentration, however the preamble is to just measuring or detecting FGF-23. Thus it is unclear if the wherein clause limits the sample, the antibodies, assay conditions, etc to provide for the required range.
Claim 2 recites, “The method for separating a bonded wafer according to claim 1, wherein the epitaxial functional layer has a light emitting device structure.” This limitation is confusing and unclear as claim 1 does not provide a step for separating a bonded wafer or antecedent basis for “the epitaxial functional layer has a light emitting device structure.” Thus the claim is confusing and unclear how it relates to claim 1.
Claim 3 recites, “wherein the sample comprises FGF-23 in a concentration ranging from 5 pg/mL to 10,000 pg/mL when subjected to the reaction, and/or (b) the sample comprising FGF-23 in a concentration ranging from 5 pg/mL to 10,000 pg/mL is directly subjected to the reaction.” However, the preamble recites, “A method for measuring fibroblast growth factor-23 (hereinafter indicated as FGF-23) in a sample.” Thus the metes and bounds are confusing and unclear as the wherein clause appears to require a specific range of FGF-23 concentration, however the preamble is to just measuring or detecting FGF-23. Thus it is unclear if the wherein clause limits the sample, the antibodies, assay conditions, etc to provide for the required range.
Claim 4 recites, “wherein the sample comprises FGF-23 in a concentration ranging from 5 pg/mL to 10,000 pg/mL.” However, the preamble recites, “A method for measuring fibroblast growth factor-23 (hereinafter indicated as FGF-23) in a sample.” Thus the metes and bounds are confusing and unclear as the wherein clause appears to require a specific range of FGF-23 concentration, however the preamble is to just measuring or detecting FGF-23. Thus it is unclear if the wherein clause limits the sample, the antibodies, assay conditions, etc to provide for the required range. Further claim 4 recites, “determining a concentration of FGF-23 in the sample by comparing a measured value obtained in (c) with a calibration curve prepared using known concentrations of FGF-23 ranging from 5 pg/mL to 10,000 pg/mL.” The metes and bounds are unclear as there is no step ©. Thus the metes and bounds are unclear.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Luethy (2006/0160181), Ibrahim (Int Urol Nephrol (2009) 41:163–169), Kazama et al (Kidney International Vol. 67, pp 1120-1125, 2005), Pandian (US Patent Number 7,439,026).
Leuthy teaches, “[0211]The anti-FGF-23 antibodies of the invention may be employed in any known assay method, such as competitive binding assays, direct and indirect sandwich assays, and immunoprecipitation assays (Sola, Monoclonal Antibodies: A Manual of Techniques 147-158 (CRC Press, Inc., 1987)) for the detection and quantitation of FGF-23 polypeptides.”
Leuthy does not specifically teach the use of two antibodies, use of magnetic particles or concentration ranges.
However, Ibrahim teaches detection of FGF-23 in serum in subjects in chronic hemodialysis,(title). Ibrahim teaches, “Serum FGF23 level was markedly elevated in the study patients compared with healthy controls (1525 ± 373 pg/ml vs. 37 ± 9 pg/ml, P\0.0001). Serum FGF23 was markedly elevated in all haemodialysis patients irrespective of serum calcium and phosphate levels” (165, bottom 1st column-2nd column). Ibrahim teaches, “FGF23 (pg/ml) 1525 ± 373 (845–2196)) table 1, bottom)
Kazama teach serum FGF-23 levels can be used to predict the efficacy of calcitrol therapy in dialysis patients. (See abstract). Kazama et al measured FGF-23 levels in serum samples taken from patients who were undergoing hemodialysis, and further indicate that such patients were also treated with anticoagulants. Kazama et al further teach that antibodies to FGF-23 were known in the art. (See page 1121).
As is made clear in the discussion by Pandian et al of other sandwich immunoassay formats, reacting the sample with the two antibodies results in formation of an immunocomplex involving the two antibodies, the magnetic particle, and the antigen. (See column 13, lines 36-56; Example 1). Furthermore, Pandian et al make clear that their sandwich assay formats that use magnetic particles involve washing by exposure to a magnetic field to immobilize the magnetic particles, allowing solution to be removed from the well while antigen remains bound to the magnetic particles that are immobilized by the magnetic field.
Pandian teach of sandwich immunoassay methods using streptavidin-coated magnetic particles and biotinylated antibodies. The methods may be conducted in one of three formats, the first being a simultaneous assay format in which two antibodies (capture and labeled antibody) and the solid phase (magnetic particles) are incubated with the sample at the same time. The antibodies should recognize different epitopes of the antigen being assayed. (See column 13, lines 4-35; column 10, lines 4-54, column 12 line 11 to column 13, line 3; and column 14, line 58 to column 15, line 3). Pandian et al teach measuring antigen (ITA in this case) in biological samples including blood, and further teach providing the immunoassay reagents in liquid solutions such as those containing PBS buffer. (See column 5, line 66 to column 6, line 39; column 9, lines 49-51; column 13, lines 36-38; column 14, lines 61-66; and Example 1). Pandian et al further teach antibodies labeled with alkaline phosphatase. (See column 8, lines 5-18). Pandian teaches the use of a standard curve to determine concentrations (example 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to adapt the sandwich immunoassay format of Pandian et al in order to measure serum FGF-23 and a standard curve in the ranges of the claims in hemodialysis patients undergoing anticoagulant treatment in order to predict whether patients are likely to benefit from treatment with calcitriol therapy. More particularly, it would have been obvious to adapt sandwich immunoassay format of Pandian et al to the detection of FGF-23 as the antigen by providing antibodies specific to FGF-23, which were known in the art as indicated by Kazama, Ibrahim, and Luethy. One of ordinary skill in the art would have had a reasonable expectation of success in measuring serum FGF-23 in such patients using known sandwich immunoassay format of Pandian et al because Kazama, Ibrahim, and Luethy taught that serum FGF-23 can indeed be successfully measured by sandwich immunoassay.
Claim 2 is rejected over the prior art as it is indefinite and thus appears to be within the teachings of the cited prior art.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No12,498,366. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Instant claims are drawn to a method for measuring fibroblast growth factor-23 (hereinafter indicated as FGF-23) in a sample, wherein the method comprises the steps of: (1) reacting, in an aqueous medium, FGF-23 in a sample with a magnetic particle, a first antibody or a fragment thereof which binds to FGF-23, and a second antibody or a fragment thereof which binds to FGF-23, to form on the magnetic particle an immunocomplex comprising the first antibody or a fragment thereof which binds to FGF-23, FGF-23, and the second antibody or a fragment thereof which binds to FGF-23, wherein the sample comprises FGF-23 in a concentration ranging from 1,000 pg/mL to 10,000 pg/mL; (2) collecting the magnetic particle in the reaction mixture after step (1) by magnetic force, and separating the magnetic particle collected by magnetic force from the other components; and (3) measuring the immunocomplex on the magnetic particle separated in step (2).
The claims of 366 are drawn to A method for measuring fibroblast growth factor-23 (FGF-23) in a sample, which comprises the steps of: (1) reacting in a first aqueous medium, a sample and a first antibody produced by FERM BP-7838 hybridoma or an antibody fragment thereof which binds to FGF-23 to produce Immunocomplex 1 consisting of FGF-23 and the first antibody or the antibody fragment thereof which binds to FGF-23; (2) reacting in a second aqueous medium, a second antibody produced by FERM BP-7839 hybridoma or an antibody fragment thereof which binds to FGF-23 with Immunocomplex 1 produced in the aforementioned step (1) to produce Immunocomplex 2 consisting of the first antibody or the antibody fragment thereof which binds to FGF-23, FGF-23, and the second antibody or the antibody fragment thereof which binds to FGF-23; and (3) measuring Immunocomplex 2 produced in the aforementioned step (2); wherein the first aqueous medium comprises at least one type of surfactant selected from the group consisting of NONION E-230, NONION K-220, PLONON 208, and NEWCOL 740, or the first aqueous medium comprises at least one type of surfactant selected from the group consisting of NONION E-230, NONION K-220, PLONON 208, and NEWCOL 740 and the second aqueous medium is the same as first aqueous medium.
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention the claims of 366 were a species which anticipates the instant claims.
Claims 1-4 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,422,796. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Instant claims are drawn to a method for measuring fibroblast growth factor-23 (hereinafter indicated as FGF-23) in a sample, wherein the method comprises the steps of: (1) reacting, in an aqueous medium, FGF-23 in a sample with a magnetic particle, a first antibody or a fragment thereof which binds to FGF-23, and a second antibody or a fragment thereof which binds to FGF-23, to form on the magnetic particle an immunocomplex comprising the first antibody or a fragment thereof which binds to FGF-23, FGF-23, and the second antibody or a fragment thereof which binds to FGF-23, wherein the sample comprises FGF-23 in a concentration ranging from 1,000 pg/mL to 10,000 pg/mL; (2) collecting the magnetic particle in the reaction mixture after step (1) by magnetic force, and separating the magnetic particle collected by magnetic force from the other components; and (3) measuring the immunocomplex on the magnetic particle separated in step (2).
The claims of 796 are drawn A method for measuring fibroblast growth factor-23 (FGF23) in a serum or plasma sample, comprising: (1) simultaneously reacting, in an aqueous medium, FGF23 in the sample with (i) a magnetic particle, (ii) a first antibody which binds to FGF23, and (iii) a second antibody which binds to FGF23, to form on the magnetic particle an immunocomplex comprising the first antibody, FGF23, and the second antibody in a reaction mixture, wherein the first antibody is an anti-FGF-23 monoclonal antibody produced by hybridoma deposited as FERM BP-7838, and the second antibody is an anti-FGF-23 monoclonal antibody Fab or Fab′ fragment produced by digesting anti-FGF23 monoclonal antibody produced by the hybridoma deposited as FERM BP-7839, the magnetic particle does not directly immobilize the first antibody; and one of two substances with affinity to each other is fixed to the magnetic particle and the other of the two substances with affinity to each other is bound to the first antibody, (2) collecting the magnetic particle after step (1) by magnetic force, and separating the magnetic particle collected by magnetic force from the other components; and (3) measuring the immunocomplex on the magnetic particle separated in step (2).
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention the claims of 796 were a species which anticipates the instant claims.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No12,092,637. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Instant claims are drawn to a method for measuring fibroblast growth factor-23 (hereinafter indicated as FGF-23) in a sample, wherein the method comprises the steps of: (1) reacting, in an aqueous medium, FGF-23 in a sample with a magnetic particle, a first antibody or a fragment thereof which binds to FGF-23, and a second antibody or a fragment thereof which binds to FGF-23, to form on the magnetic particle an immunocomplex comprising the first antibody or a fragment thereof which binds to FGF-23, FGF-23, and the second antibody or a fragment thereof which binds to FGF-23, wherein the sample comprises FGF-23 in a concentration ranging from 1,000 pg/mL to 10,000 pg/mL; (2) collecting the magnetic particle in the reaction mixture after step (1) by magnetic force, and separating the magnetic particle collected by magnetic force from the other components; and (3) measuring the immunocomplex on the magnetic particle separated in step (2).
The claims of 637 are drawn A method for measuring fibroblast growth factor-23 (FGF-23) in a sample, wherein the method comprises the steps of: (1) reacting, in an aqueous medium, FGF-23 in a sample with a magnetic particle bonded with a first antibody or a fragment thereof which binds to FGF-23, and a second antibody or a fragment thereof which binds to FGF-23, to form on the magnetic particle an immunocomplex comprising the first antibody or a fragment thereof which binds to FGF-23, FGF-23, and the second antibody or a fragment thereof which binds to FGF-23, wherein the sample comprises FGF-23 in a concentration ranging from 5 pg/mL to 10,000 pg/mL; (2) collecting the magnetic particle in the reaction mixture after step (1) by magnetic force, and separating the magnetic particle collected by magnetic force from the other components; and (3) measuring the immunocomplex on the magnetic particle separated in step (2)..
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention the claims of 637 were a species which anticipates the instant claims.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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, Anne Gussow can be reached at (571)272-6047. 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.
/Steven Pohnert/ Primary Examiner, Art Unit 1683