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 .
Priority
Applicant’s claim for the benefit of prior-filed application 18/072,362 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2) during the interview on September 18th, 2025 is acknowledged.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2009/0047297) in view of Miltenyi (US 6417011) and in view of legal precedent.
Regarding claim 1, Kim et al. (US 2009/0047297) teaches a method for sorting biological objects (Paragraph 0001 lines 1-2) comprising the steps of:
providing a magnetic device (Paragraph 0028 lines 1-9) that includes a conduit (Fig. 1 #5) or channel having upstream and downstream sections (Fig. 1 see upstream and downstream sections of #5) and a magnetic means (Fig. 1 #6, 7, Paragraph 0028 lines 1-9) for generating first and second magnetic fields in the upstream and downstream sections, respectively (Fig. 1 #6 generates first magnetic field in upstream section of #5, #7 generates second magnetic field in downstream section of #5);
flowing a sample fluid (Fig. 1 #9, 10) that includes magnetically labeled biological objects (Fig. 1 #11 labeled by #8 forms #13 “bound particles”) and unlabeled biological objects (Fig. 1 #12) through the upstream section to magnetically saturate the magnetically labeled biological objects by the first magnetic field (Paragraph 0033 lines 8-21); and
flowing the sample fluid from the upstream section continuously to the downstream section (Fig. 1 #9, 10 flowing continuously from upstream section of #5 to downstream section of #5) to collect the magnetically labeled biological objects (Fig. 1 #13) in the downstream section (Fig. 1 #13 collected in downstream section of #5) by the second magnetic field (Paragraph 0035 lines 1-16).
Kim et al. (US 2009/0047297) lacks teaching flowing the sample fluid from the upstream section continuously to the downstream section to collect the magnetically labeled biological objects on a wall of the downstream section by the second magnetic field, and wherein the first magnetic field in the upstream section has a higher average field strength than the second magnetic field in the downstream section. Kim et al. (US 2009/0047297) however explains that the device can be provided with an automatic control device for controlling the magnetic field strengths or magnetic field gradients (Paragraph 0019 lines 1-3), and hence the marking or binding of biological particles and their isolation is possible in a simple and controlled manner (Paragraph 0019 lines 11-13).
Miltenyi (US 6417011) teaches a method for sorting biological objects (Col. 1 lines 14-16) comprising: flowing the sample fluid from the upstream section (Fig. 1 upstream section of #11) continuously to the downstream section (Fig. 1 downstream section of #11) to collect the magnetically labeled biological objects on a wall of the downstream section (Col. 11 lines 8-10) by the second magnetic field (Fig. 1 magnetic field of #12, Col. 11 lines 2-10), and wherein the first magnetic field has a higher average field strength (Col. 6 lines 55-67) than the second magnetic field (Fig. 1 magnetic field of #12) in the downstream section (Col. 4 lines 35-39).
Miltenyi (US 6417011) explains that the magnetic field is applied with sufficient strength to obtain a gradient which retains the magnetic particles on the surface, but contaminating substances which have no magnetic properties flow through the column, and when the magnetic field is released or diminished, the retained particles are eluted (Col. 11 lines 15-35). Miltenyi (US 6417011) further explains that mixtures of target materials with different magnetizations can be retained, and then each target material may be eluted individual, thus effecting a clean separation (Col. 12 lines 1-14). Miltenyi (US 6417011) states that the strength of the magnetic field imposed on the particles determines their magnetization, but the magnetized particles are retained as a function of the strength of the magnetic gradient (Col. 4 lines 35-39).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. (US 2009/0047297) to include flowing the sample fluid from the upstream section continuously to the downstream section to collect the magnetically labeled biological objects on a wall of the downstream section by the second magnetic field, and wherein the first magnetic field in the upstream section has a higher average field strength than the second magnetic field in the downstream section as taught by Miltenyi (US 6417011) in order to separate multiple different target materials with a clean separation, and in order to provide a high magnetization to the particles prior to collection by the second magnetic field.
Additionally, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. (US 2009/0047297) to include wherein the first magnetic field in the upstream section has a higher average field strength than the second magnetic field in the downstream, as Kim et al. (US 2009/0047297) explains that the magnetic field strengths or magnetic field gradients may be controlled by an automatic control device in order to provide the binding of biological particles and their isolation in a simple and controlled manner (Paragraph 0019 lines 1-13, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding claim 2, Kim et al. (US 2009/0047297) lacks teaching the method of claim 1, wherein the second magnetic field in the downstream section has a higher field gradient than the first magnetic field in the upstream section. Kim et al. (US 2009/0047297) however explains that the device can be provided with an automatic control device for controlling the magnetic field strengths or magnetic field gradients (Paragraph 0019 lines 1-3), and hence the marking or binding of biological particles and their isolation is possible in a simple and controlled manner (Paragraph 0019 lines 11-13).
Miltenyi (US 6417011) teaches a method for sorting biological objects (Col. 1 lines 14-16) wherein the second magnetic field in the downstream section (Fig. 1 magnetic field of #12 in downstream section of #11) has a higher field gradient than the first magnetic field in the upstream section (Col. 4 lines 35-39).
Miltenyi (US 6417011) explains that the chamber across which the magnetic field is applied is often provided with a matrix of a material of suitable magnetic susceptibility to induce a high magnetic field gradient locally in the chamber in volumes close to the surface of the matrix, and this permits the retention of fairly weakly magnetized particles (Col. 1 lines 48-55). Miltenyi (US 6417011) states that the strength of the magnetic field imposed on the particles determines their magnetization, but the magnetized particles are retained as a function of the strength of the magnetic gradient, and magnetized particles are retained by high magnetic gradients (Col. 4 lines 35-39).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. (US 2009/0047297) to include wherein the second magnetic field in the downstream section has a higher field gradient than the first magnetic field in the upstream section as taught by Miltenyi (US 6417011) in order to retain the magnetized particles regardless of the magnetization strength thereof.
Additionally, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Kim et al. (US 2009/0047297) to include wherein the second magnetic field in the downstream section has a higher field gradient than the first magnetic field in the upstream section, as Kim et al. (US 2009/0047297) explains that the magnetic field strengths or magnetic field gradients may be controlled by an automatic control device in order to provide the binding of biological particles and their isolation in a simple and controlled manner (Paragraph 0019 lines 1-13, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Molly K Devine whose telephone number is (571)270-7205. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/MOLLY K DEVINE/ Examiner, Art Unit 3653