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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-16 in the reply filed on 04/02/26 is acknowledged. The traversal is on the ground(s) that the claims include the special technical feature of separating a moiety that includes the labeling substance from the complex and moving the moiety to a second reaction field for detection, which is not taught or suggested in Konrath. This argument is not found persuasive because (1) this limitation is not a special technical feature of the reagent of claim 18. This limitation is intended use of a reagent in a method and does not limit the reagent in any sense. Konrath discloses a reagent which has an action of separating a linking moiety having a labeling substance (e.g. Table 1, page 7). This metes the limitation of the reagent. All other recitations are intended use of the reagent in a method; (2) Regardless, the prior art below teaches the separating a moiety that includes the labeling substance from the complex and moving the moiety to a second reaction field for detection. The requirement is still deemed proper and is therefore maintained.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g. page 6, paragraph 0009). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 2 is 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 2, line 2 the recitation “plate-like” is indefinite. The recitation “plate-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonable apprised of the scope if the invention. It is unclear if applicant is referring to plate or a characteristic of a plate. Please clarify.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-9, 13-14 and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Quan et al (US 2022/0128446).
Quan et al discloses a method of detecting target analytes (target substance) (e.g. abstract, para 0202). Quan et al discloses an assay comprising beads (solid phase) coated with capture antibodies (first trapping substance) that bind to corresponding analytes (target substance) combined with the sample and detection antibodies (second trapping substance) labeled with oligonucleotides by a cleavable linker. Quan et al discloses that the oligonucleotides can comprise a label (e.g. para 0202). Quan et al discloses that the beads are mixed with the sample and the detection antibodies and sandwich complexes are formed (first complex in a first reaction field). Quan et al discloses washing the complexes to remove unbound detection antibody and cleaving the linker to release the oligonucleotides and then moving the oligonucleotide (moiety) to an array of complimentary oligos to the oligos linked with antibodies and detecting signal of the captured moiety to detect the analyte (e.g. para’s 0188, 0202). Quan et al discloses that the label can be an enzyme label or fluorescent label (e.g. para 0196). Quan et al discloses that when an enzyme is used as a label the assay includes the addition of an appropriate enzyme substrate that produces a signal (e.g. para 0196). Quan et al discloses that the cleavage can be performed with the use of an enzyme treatment (e.g. para 0197).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Quan et al in view of Gordon (US 2019/0079084).
See above for the teachings of Quan et al.
Quan et al differ from the instant invention in failing to teach the beads are magnetic particles.
Gordon shows that it is known and conventional in sandwich assays to have a solid substrate such as a magnetic particle (e.g. para 0082). Gordon teaches that this allows non-specific materials in the sample to be magnetically separated from the analytes bound to the particles to reduce the impact of noise that could interfere with the detection signal (e.g. para 0082).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate magnetic particles for the beads of Quan et al because Quan et al is generic with respect to the composition of the beads and Gordon teaches that the use of such particles allows non-specific materials in the sample to be magnetically separated from the analytes bound to the particles to reduce the impact of noise that could interfere with the detection signal. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating magnetic particles for the beads of Quan et al.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al in view of Li et al (Analytical Biochemistry, 359, 2006, pages 247-252).
See above for the teachings of Quan et al.
Quan et al differ from the instant invention in failing to teach the label is a metal colloid particle and carrying out an amplification reaction for amplifying the signal.
Li et al teaches that it is known and conventional in the art to provide colloidal gold labels in sandwich assays and to provide signal amplification by silver precipitation on the colloidal gold labels wherein a large amount of silver is deposited on each colloidal gold label to produce a much larger particles which provides high sensitivity (e.g. abstract, page 248, first col).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate colloidal gold labels for the label and amplification steps such as taught by Li et al in the method of Quan et al because Quan et al specifically teaches that the label can be a gold particle (e.g. para 0196) and Li et al shows that this label and amplification provides for an assay with high sensitivity. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating colloidal gold labels and amplification such as taught by Li et al into the method of Quan et al.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Quan et al in view of Pettersson et al (6,429,026).
See above for the teachings of Quan et al.
Quan et al differ from the instant invention in failing to teach the second reaction field has a smaller volume.
Pettersson et al teaches that it is known and conventional in the art that reaction rate of assay can be increased by reducing the total volume (e.g. col 5, lines 29-50).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a smaller volume such as taught by Pettersson et al into the detection in the second field of Quan et al because Pettersson et al shows that it is known and conventional in the art that this provides for increased reaction rate. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating a smaller volume such as taught by Pettersson et al into the detection in the second field of Quan et al. Further, With respect to the recitation “wherein the second reaction field has a volume smaller than a volume the first reaction field has” as recited in claim 15”. The optimum volume for each reaction field can be determined by routine experimentation and therefore would have been obvious to one of ordinary skill in the art. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
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 1-10 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/859,064 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and application 18/859,064 are directed to methods of detecting a target substance comprising forming a sandwich complex of immobilized antibody/target substance/labeled antibody; separating a moiety including the labeling substance from the formed complex and moving the separated moiety to another field for detection and one of ordinary skill would understand that the more comprehensive claims of 18/859,064 requiring a liquid filled tubular channel and separation by a centrifugal force would encompass the generic moving in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Briggs et al (US 2020/0340943) discloses a method of detecting a target protein by forming a complex of magnetic beads having capture antibodies with target protein and a proxy label with secondary detection antibody. Briggs et al discloses washing while holding the target molecules and proxy labels in place, removing the proxy label and detecting proxy label which directly corresponds with the target molecule concentration (e.g. para 0088).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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