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 1-6 and 8-20 are pending. Claims 1 and 12-15 have been amended. Claim 7 has been cancelled. Claims 12-15 have been rejoined. Claims 1-6 and 8-20 have been examined.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 states “HGMS” and should spell out the acronym on its first appearance in the claims.
Appropriate correction is required.
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 15 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 15 is confusing because it states that the working electrode is a matrix of a HGMS-based device comprising a ferromagnetic material. However, it is unclear if the working electrode is the HGMS-based device comprising a ferromagnetic material or alternatively if the matrix is comprised of both the working electrode and a ferromagnetic material.
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.
Claim(s) 1-6, 8-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kusumoto et al. (US2006/0186055, hereinafter “Kusumoto”, IDS) in view of Berensmeier et al. (US 2019/0204312, Pub Date: 07/04/2019, hereinafter “Berensmeier”).
Regarding claim 1, Kusumoto teaches throughout the publication a method for separating biomolecules from a liquid medium (paragraph 0008), comprising: adding magnetic particles to the liquid medium comprising the biomolecules, the biomolecules each adapted to bind to respective surfaces of the magnetic particles; bringing the liquid medium to which the magnetic particles have been added into contact with a collector by allowing the liquid medium to which the magnetic particles have been added into pass through a flow cell comprising a chamber and the collector, the collector comprising a working electrode; applying a magnetic field to the liquid medium in contact with the collector to attract the magnetic particles bound with the biomolecules to a surface of the collector; and applying an electric potential to the surface of the collector to release the biomolecules from the magnetic particles (paragraphs 0009, 0011, 0021-0022: groove is placed inside substrate and a space is formed inside the chip – the groove having at least one compartment and a flow passage communicating with the compartment, 0036 and 0052-0054 – see also paragraph 0053, extracted material transferred to a positive electrode or that the extracted nucleic acid moves in the direction of the positive electrode). While Kusumoto does not explicitly teach that the electrode is present in the chamber, it would be obvious that when manipulating the extracted material, that this would be conducted within some portion of the groove comprising the compartment and flow passage.
While Kusumoto teaches the presence of magnetically responsive particles, the reference fails to explicitly teach that the particles are nanoparticles.
Berensmeier teaches throughout the publication methods of binding molecules to iron oxide-containing magnetic particles (paragraph 0007). More specifically, Berensmeier teaches that the ideal surface for binding is magnetic nanoparticles (paragraph 0035).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the magnetic responsive particles in the method of Kusumoto with magnetic nanoparticles as taught by Berensmeier because Kusumoto is generic regarding the magnetic responsive particles and one skilled in the art would have been motivated to choose the particle size based on the desired particle and binding configuration.
Regarding claim 2, Kusumoto teaches that the magnetic particles bind to proteins (paragraphs 0008-0011) but fails to teach that the biomolecules comprise proteins fused with peptide tags. Berensmeier teaches the use of proteins fused with peptide tags (paragraph 0050) that can be bound with a magnetic nanoparticle (paragraph 0057) and then separated (paragraph 0088). It would have been prima facie obvious to one skilled in the art to incorporate as the biomolecule in the method of Kusumoto, protein fused with peptide tags as taught by Berensmeier because Kusumoto is generic regarding the proteins that can be analyzed with the magnetic separation methods and one skilled in the art would have been motivated to choose the appropriate biomolecule based on the desired analysis and discovery to be conducted.
Regarding claim 3, Kusumoto in view of Berensmeier teach the method wherein the peptide tags comprise charged peptide tags (Berensmeier, paragraph 0106).
Regarding claim 4, Kusumoto in view of Berensmeier teach the method wherein an electrostatic repulsion is created between the magnetic nanoparticles and the charged peptide tags upon the application of the electric potential (Kusumoto, paragraph 0009 and 0052 and Berensmeier, paragraph 0106).
Regarding claim 5, Kusumoto in view of Berensmeier teach the method wherein the peptide tags form charge transfer complexes with the respective surfaces of the magnetic nanoparticles, the complex formation being breakable by a change of electrostatic interactions (Kusumoto, paragraph 0009 and Berensmeier, paragraph 0106; this limitation is inherently conducted based on the charge of the peptide tags/magnetic nanoparticles of the prior art references).
Regarding claim 6, Kusumoto teaches the method further comprising collecting the biomolecules released from the magnetic nanoparticles (paragraphs 0052-0056).
Regarding claim 8, Kusumoto teaches the method further comprising, before the application of the electric potential, separating the collector from the liquid medium; and bringing at least part of the collector into contact with another liquid medium (paragraph 0058).
Regarding claim 9, Kusumoto in view of Berensmeier teach the method wherein the magnetic nanoparticles comprise iron oxide nanoparticles (Kusumoto, paragraphs 0033-0034 and Berensmeier, paragraph, 0032).
Regarding claim 10, Kusumoto in view of Berensmeier teach the method wherein the peptide tags comprise negatively charged peptide tags (Berensmeier, paragraph 0106) and the method comprises applying a negative electric potential to the collector to repulse the proteins fused with the negatively charged peptide tags, thereby releasing the biomolecules from the magnetic nanoparticles (Kusumoto, paragraphs 0009 and 0052-0053).
Regarding claim 11, Kusumoto in view of Berensmeier teach the method further comprising removing the magnetic field to release the magnetic nanoparticles from the collector (Berensmeier, paragraph 0105).
Regarding claim 12, Kusumoto teaches the method wherein the chamber comprises an outlet which define therebetween a fluid path for the liquid medium (paragraph 0029), and a volume for containing the liquid medium provided along said fluid path, the volume comprising a collecting area for the biomolecules (paragraph 0042); and a magnetic source proximal to the volume of the chamber, the magnetic source arranged and configured to generate the magnetic field extending at least between the collecting area and the remaining volume for containing the liquid medium (paragraph 0039 and see Figure 3, magnet driving device; the volume of the chamber ranges from 1,000 mm3 to 10 m3 (paragraph 0042).
Regarding claim 13, Kusumoto teaches the method wherein the magnetic source is a permanent magnet or electromagnet (paragraph 0048).
Regarding claim 14, Kusumoto teaches the method wherein the chamber is part of a system that further comprises recovery chambers (paragraph 0060) and a supply unit in fluid communication with the inlet of the chamber for supplying the liquid medium to the chamber (paragraph 0029, space outside chip to inject sample).
Regarding claim 16, Kusumoto in view of Berensmeier teach the method further comprising attaching the peptide tags to the proteins (Berensmeier, paragraph 0050 and 0100-0103).
Regarding claim 17, Kusumoto in view of Berensmeier teach the method wherein the peptide tags comprise negatively charged peptide tags (Berensmeier, paragraph 0106).
Regarding claim 18, Kusumoto in view of Berensmeier teach the method wherein the magnetic nanoparticles comprise superparamagnetic iron oxide nanoparticles (SPION) (Kusumoto, paragraph 0033 and Berensmeier, paragraph, 0096).
Regarding claim 19, Kusumoto in view of Berensmeier teaches the method further comprising collecting the magnetic nanoparticles released from the collector (Berensmeier, paragraph, 0105).
Regarding claim 20, although Kusumoto does not specifically teach that the electric potential applied to the surface of the collector is in the range of -1 to 1V, 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 for 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.” Since applicant has not disclosed that the specific limitations recited in instant claim 20 are for any particular purpose or solve any stated problem, and the prior art teaches that voltages applied can varied depending on the particles and material to be extracted. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the separation device art.
Response to Arguments
Applicant’s arguments filed 02/02/2026 have been considered. Applicant argues that Kusumoto fails to teach the recited working electrode, especially since the electric field disclosed in Kusumoto is applied by an external power supply. These arguments are not persuasive because 1) Kusumoto specifically teaches at paragraph 0053 that the extracted nucleic acid can be transferred to a positive electrode or that the extracted nucleic acid moves in the direction of the positive electrode. While Kusumoto does not explicitly teach that the electrode is present in the chamber, it would be obvious that when manipulating the extracted material, that this would be conducted within some portion of the groove comprising the compartment and flow passage. 2) Claim 1 as currently recited does not limit the working electrode disposed in the chamber to also be the source of the applied electric potential – the claim broadly states that the collector comprises a working electrode and then additionally states the application of the electric potential. As the source of the electric potential has not been explicitly limited to be the working electrode disposed within the chamber, the working electrode taught at paragraph 0053 of Kusumoto reads on the limitation even if the electric potential of Kusumoto is being applied by a power supply.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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