DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The submission filed on 06/21/2024 has been entered. Claims 1-6 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/TR2022/051527 filed on 12/19/2022 and claims foreign priority of TÜRKİYE 2021/020554 filed on 12/21/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/21/2024 has been considered.
Claim Objections
Claims 1-6 are objected to because of the following informalities: In claim 1, delete the excessing recitation “characterized by” (line 2); insert the missing conjunction “and” before the recitation “configured” (lines 3 and 10); change the incorrect recitation “that is positioned” (line 6) to “and is positioned” to tie with the preceding “magnetic gradient patch”, not “polymer”; replace the incorrect recitation “it is not in” (line 7) with “the magnetic gradient patch is not in” to tie with the preceding “magnetic gradient patch”, not polymer; delete the incorrect recitation “to be placed” (line 8) because the preceding clause requires the biological material present in the tube; and to change the incorrect recitation “that is in direct” (line 8) to “but is in direct” to tie with the preceding “magnetic gradient patch”. In claims 2-6, change the incorrect recitation “, characterized in that,” (line 1 of claims 2-6) to proper dependent claim format “, wherein”. Also, in claim 2, delete the excessive recitations “the group comprising” (lines 1 to 2) and “which is” (line 3) to tie with the subsequent recitation “is selected”. In claim 3, delete the excessive recitation “the group comprising” (lines 1 to 2) to tie with the subsequent recitation “is selected”. In claim 5, delete the excessive recitation “between” (line 2). Appropriate correction is required.
Note: The recitation “A kit” in the beginning of claims 2-6 is suggested to be changed to “The kit” according to MPEP 608.01(n) [R- 01.2024][IV. CLAIM FORM AND ARRANGEMENT].
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 1-6 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 1-6 recite “flat bottom tube (1)”, “magnetic gradient patch (2)”, “the tube (1)”, “mold (3)”, and/or “magnetic gradient patch (1)”. It is not clear if the “(1), “(2)”, and “(3) are designated to a generic structure and a specific structure as shown in Figure 1. To obtain the broadest reasonable interpretation, Applicant is advised to delete the above numbers.
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.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hirota et al. (Physica B 346–347 (2004) 267–271, hereinafter referred to as Hirota ‘2004) in view of Weissleder et al. (US 2013/0271250, Oct. 17, 2013, hereinafter referred to as Weissleder ‘250).
With regard to structural limitations “a kit comprising a flat bottom tube (or thickness between 0.1 mm and 1 mm) made of glass and configured to contain biological material (or body fluid or blood), a modular and reusable magnetic gradient patch that is made of ferromagnetic metal powder (or neodymium-iron-boron, Nd-Fe-B, alloy) and polymer (or polydimethylsiloxane, PDMS; or the metal powder/polymer ratio of 0.001-10% by weight) and is positioned outside and below the tube; and a mold positioned under the flat-bottom tube and configured to put the magnetic gradient patch” (claims 1-6):
Hirota ‘2004 disclosed a novel magnetic separation method, which utilizes the magneto-Archimedes levitation, has been introduced and applied to separation of biological materials. The magnet used in this study was cryo-cooler-operated superconducting magnet (Sumitomo Heavy Industries; HF-12-100VHT). It has a vertical room temperature bore with a diameter of 100 mm and can generate 12 T at the center. A mixture of different biological materials to be separated was filled into glass tube. The tube was pressurized with oxygen gas. After introduced into the magnet bore, the glass tube was shaken lightly to keep particles apart. Three clusters of powder are formed and stably floated in the oxygen atmosphere: Cholesterol (upper), DNA (middle), and hemoglobin (lower) levitated at different positions by the magneto-Archimedes separation (page 267, Abstract; page 269, left col., para. 2; right col., para. 1; page 270, Fig. 4). For the case of magneto-Archimedes levitation, the effect of the surrounding medium (gas or liquid) has to be taken into account. In magneto-Archimedes separation, one can choose which factor should be emphasized, the difference of magnetic susceptibilities or the difference of densities, by selecting proper media. The diamagnetic levitation needs an extraordinary high and steep magnetic field gradient because the magnetic susceptibility of the diamagnetic materials is very small. Hence, it seems difficult to apply diamagnetic levitation for practical industrial processes. There is another way of levitation, called ‘‘magneto-Archimedes levitation’’. With this technique, levitation can be easily achieved by simply using a common superconducting magnet. Moreover, even paramagnetic materials can be levitated by controlling the surroundings of the object (page 268, right col., para. 3; page 271, left col., para. 1; page 267, right col., para. 1 to page 268, left col., para. 1).
Hirota ‘2004 did not explicitly disclose the limitations “reusable magnetic gradient patch that is made of ferromagnetic metal powder (or neodymium-iron-boron, Nd-Fe-B, alloy) and polymer (or polydimethylsiloxane, PDMS; or the metal powder/polymer ratio of 0.001-10% by weight)”, “a mold positioned under the flat-bottom tube and configured to put the magnetic gradient patch”, “a flat bottom tube having thickness between 0.1 mm and 1 mm”, and/or “body fluid or blood”, required by claims 1-6.
Weissleder ‘250 disclosed self-assembled magnetic (SAM) devices including an array of self-assembled magnetized particles, in which the magnetic dipole direction of each particle in a majority of the magnetized particles is substantially opposite to the magnetic dipole direction of a directly adjacent particle or directly adjacent particles in the array. The magnetic field contribution from each magnetized particle can provide the array with an overall magnetic field having a high magnitude and field gradient, thus producing a strong magnetic force. The strong magnetic forces of the self-assembled device can be used to enhance applications such as, sorting/filtering of cells and/or molecules and other analytes. In some cases, the self-assembled magnetic device include a substrate and an array including a plurality of magnetic particles on the substrate. In certain implementations, each magnetic particle in the array is composed of NdFeB, SmCo, FePt, or iron oxide. In some implementations, the magnetic devices further include a suspension layer, in which the array of magnetic particles is located, e.g., dispersed, within the suspension layer. The suspension layer can include a curable polymer. The polymer can include any one or a combination of polyurethane, epoxy, poly(methyl methacrylate) (PMMA), or polydimethylsiloxane (PDMS). In certain implementations, the magnetic devices further include a cell culture medium container adjacent to the array. FIG. 8 shows a cell culture medium 86 is positioned directly above an array 82 of self-assembled magnetic particles 84 (page 20/30, [0004-0008]; page 27/30, [0081]). The proportion, by weight, of polymer to magnetizable material can range from about 5:1 to about 15:1 including, about 6:1, 7:1, 8:1, 9:1, 10:1, 11:1, 12:1, 13:1, and 14:1. Fig. 4:
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. In some cases, the suspension liquid 11a is placed in a mold on substrate 18 in order to confine the area over which the polymer spreads. The magnitude of the applied magnetic field required to magnetize the particles 14a depends on the particle material and can include fields greater than 1 Tesla, including, about 1.5 Tesla, about 2 Tesla, about 3 Tesla, about 4 Tesla, about 5 Tesla, about 6 Tesla, about 7 Tesla, about 8 Tesla, about 9 Tesla, or about 10 Tesla. In some methods containing the fixed particles, the suspension layer 11b can be removed from the substrate 18 and moved into a device. Alternatively, the substrate can be part of a device. (pages 24/30 to 25/30, [0064-0067]). FIG.16 shows a graph depicting an exponential decay function fitted to the measured force versus distance from the magnet’s surface:
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. The efficiency of the self-assembled magnetic array filter was tested by sorting magnetic beads from non-magnetic polystyrene beads in suspension. One example of an application that can use the self-assembled magnetic arrays for sorting/filtering includes clearing bacteria in blood (page 28/30, [0093, 0094]; page 26/30, [0079]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the gas medium and superconducting magnet as taught by Hirota ‘2004 with liquid medium and self-assembled magnetic (SAM) device, respectively, in view of Weissleder ‘250 to separate nucleic acid by magneto-Archimedes levitation because Hirota ‘2004 teaches that a combination of high magnetic field, e.g. 12 T, and proper medium (gas or liquid) induces magneto-Archimedes levitation to separate nucleic acid from other biological materials; and Weissleder ‘250 teaches that cell medium is used in the self-assembled magnetic (SAM) device and more than 10 Tesla magnetic field can be generated by the SAM device, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the gas medium and superconducting magnet as taught by Hirota ‘2004 with liquid medium and self-assembled magnetic (SAM) device, respectively, in view of Weissleder ‘250 to separate nucleic acid by magneto-Archimedes levitation, one would achieve Applicant’s claims 1-6. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/ Primary Examiner, Art Unit 1691
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