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 the Claims
Claims 53-72 are pending and examined herein.
Priority
This application, filed 05/15/2024, is a 371 of PCT/CA2022/051679, filed 11/14/2022, which claims benefit of PRO 63/279,417, filed 11/15/2021; however, this benefit is not granted. Claim 53 of the instant application claims “A magnetic microparticle comprising a magnetic nanoparticle encapsulated by a polymer hydrogel.” This claim covers magnetic nanoparticles encapsulated by any and all polymer hydrogels, of which there are many, but provisional application 63/279,417 only describes magnetic nanoparticles encapsulated by protein-repellent polymer hydrogels. Because the scope of claim 54 of the instant application is broader than the described invention in 63/279,417, the independent claim and its dependent claims do not receive the benefit of the earlier filing date and are considered to have an effective filing date of 11/14/2022.
Information Disclosure Statement
The Information Disclosure Statements filed 05/15/2024 and 09/13/2024 are acknowledged and have been considered.
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 54-72 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.
Claims 54-72 are dependent claims which directly or indirectly depend upon independent claim 53; however, the claims all depend upon cancelled claims 1, 4, 9, 11, 14, or 16. The claims appear to be intended to be dependent on the claims in the order that the new claims were filed, e.g. dependency on claim 1 was intended to mean claim 53, dependency on claim 4 was intended to mean claim 56. For purposes of compact prosecution, dependency on claim 1 will be interpreted to mean claim 53, claim 4 means claim 56, claim 9 means 61, claim 11 means 63, claim 14 means 66, and claim 16 means 68; however, appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 54-72 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As described above under 35 U.S.C. 112(b), the dependent claims 54-72 are dependent on cancelled claims 1, 4, 9, 11, 14, and 16. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 53-65 and 68-72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al., “Engineering Hybrid Polymer Materials for Enhanced Biosensing” McMaster University Thesis (available online 10/13/2020, referred to herein as Lu).
Regarding claims 53-56, Lu teaches a magnetic microparticle microgel comprising a magnetic nanoparticle encapsulated by a three dimensional-crosslinked network of water-soluble polymers, i.e. POEGMA (p. 54, para. 1, lines 1-7, Figure 2.1).
Regarding claims 57 and 59, Lu teaches that the microgel diameter is about 5 µm (p. 80, para. 2, lines 1-5).
Regarding claim 58, Lu teaches that the nanoparticles comprise iron oxide (p. 80, para. 2, lines 6-8).
Claim 60 is considered a “Product-by-Process” claim (see MPEP 2113). Regarding product-by-
process claims, "[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)
(emphasis added). In this case, Lu teaches that the particles are made using inverse emulsion templating (p. 97, para. 1, lines 1-3); however, the claimed microparticles would be anticipated by the microparticles described by Lu regardless of the method by which they were produced.
Regarding claims 61 and 62, Lu teaches that the particles are functionalized with DNAzyme (p. 97, para. 1, lines 4-5).
Regarding claims 63 and 72, Lu teaches an assay for detecting the presence of a target analyte comprising the magnetic microparticles comprising a reporter moiety (p. 72, para. 2, lines 1-10), an electrochemical chip comprising working, counter and reference electrodes (p. 71, para. 2, lines 1-10), and a capture probe functionalized on the working electrode (p. 71, para. 2, lines 13-17), wherein binding of the target analyte results in an electrochemical signal (p. 73, para. 1, lines 1-4).
Regarding claim 64, Lu teaches that the working electrode comprises gold hierarchical structures (p. 71, para. 2, lines 7-8).
Regarding claims 65 and 69, Lu teaches the electrochemical signal is measured by square wave voltammetry (p. 73, para. 1, lines 1-3).
Regarding claims 70 and 71, the claims merely states, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, and is not considered a limitation of significance to the independent claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, the limitations of claims 70 and 71 reciting the intended use of the microparticle of claim 53 does not provide any structural difference between the claimed particles and the particles described in Lu. Further, Lu directly teaches that the particles can be used for capturing the target analyte and determining the presence of a target analyte in a sample (p. 98, para. 1, lines 6-10).
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.
Claims 66 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Zuk et al. (US 4,208,479).
Regarding claims 66 and 67, Lu teaches an assay for detecting the presence of a target analyte comprising the magnetic microparticles comprising a reporter moiety (p. 72, para. 2, lines 1-10), an electrochemical chip comprising working, counter and reference electrodes (p. 71, para. 2, lines 1-10), and a capture probe functionalized on the working electrode (p. 71, para. 2, lines 13-17), and a magnet (p. 73, para. 1, line 1). Lu teaches the sample in a container (p. 74, para. 2, lines 1-8) and read in an electrical reader (p. 73, para. 1, lines 1-7).
However, Lu does not teach all of the components in a kit.
Zuk et al. teaches the convenience and enhancement of accuracy associated with providing all necessary reagents for an assay combined in a kit (column 22, lines 20-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to package together the reagents and components of the assay taught by Lu in the form of a kit for convenience, improvement in accuracy, and/or for the purpose of commercial sale.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 3, 2026
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