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 1 and 4-12 are pending in the application.
Claims 10-12 are withdrawn.
Claims 1 and 4-9 are the subject of this office action.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: ”a control unit configured to control the relative movement of the stage and the solution transfer unit, and the suction and discharge of the solution into and from the tip, respectively”
Claim 1: “the control unit configured to control the driving part so that a magnitude of the magnetic force applied to the tip by the magnetic force applying part is adjusted to hold the magnetic particles inside the tip after the solution containing the magnetic particles is suctioned into the tip”
These limitations are interpreted under 112(f) because they recite a component “configured to” perform a specific function, wherein the structure provided by the claim (“control unit”) is a generic placeholder which does not provide sufficient structural detail to explain how the component performs the recited function. That is the particular structure of a control unit and how exactly it is configured to perform the recited function is not clear from the context of the claim. The specification provides many references to a “control unit” but does not provide any description of the specific structural features or components that make up the control unit or that explain how it is specifically configured to perform the recited functions. Further discussion is provided in the 112(b) section below.
Claim 1: “a driving part configured to provide a pressure for suctioning and discharging the solution into and from the tip, respectively”
Claim 8: “the driving part is configured to provide a pressure to each of the plurality of tips”
Claim 9: “ the driving part is configured to provide a pressure that generates a flow within the tip without discharging the solution to the outside of the tip”
These limitations are interpreted under 112(f) because they recite a component “configured to” perform a specific function, wherein the structure provided by the claim (“driving part”) is insufficient to support the function it is recited to perform. That is, a “driving part” is a generic placeholder and not a specific structure in and of itself, as it is not clear what the part is or how it “drives” or performs the particularly recited function. Structural support is found at Pg. 10 of the instant specification: “the driving part 240 may be a pump provided with pneumatic pressure”. As such, the driving part is interpreted herein to comprise a pneumatic pump and functional variants thereof.
Claim 6: “the plurality of magnets is configured to independently move toward the plurality of tips or away from the plurality of tips”
This limitation is interpreted under 112(f) because they recite a component “configured to” perform a specific function, wherein the structure provided by the claim (“plurality of magnets”) is insufficient to support the function it is recited to perform. That is, a plurality of magnets is not generally understood to be capable of independent movement in the absence of some other structure or input which is not recited. Support for this limitation is found in the instant specification at Pg. 11-12: a magnet driving part 260 capable of allowing the magnetic force applying part 230 to move in the Y axis direction” and at Pg. 10: eight magnet moving parts capable of independently driving each of the magnets may be provided”. As such, the structure associated with the recited function is understood to be magnet driving part as described at Pg. 10-12 and functional variants thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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 and 5-9 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.
Claim 5 is rejected as indefinite because the particular dimensions referred to are unclear. That is, the claim recites that the tip is viewed from “one side” but it is not clear which side this is (i.e. upper side, lower side, lateral side, etc) and also recites that the length of the magnet is greater than 80% or more than that of the tip, but does not make clear which dimension of either the magnet or the tip is its “length” such that one of ordinary skill in the art cannot determine what relationship between which particular dimensions of each component is required in order to meet the claim. Clarification is required.
Claim limitations “the control unit configured to control the driving part so that a magnitude of the magnetic force applied to the tip by the magnetic force applying part is adjusted to hold the magnetic particles inside the tip after the solution containing the magnetic particles is suctioned into the tip” in claim 1 and “a control unit configured to control the relative movement of the stage and the solution transfer unit, and the suction and discharge of the solution into and from the tip, respectively” in claim 1 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The written description provides many references to a generic “control unit” but provides no description of what the control unit is on a structural level, and does not explain how exactly the control unit is “configured to” to perform the specifically recited functions. The term “control unit” is considered a generic placeholder because it does not require any particular physical structure, and instead just refers to a generic “unit” which is modified by its intended function (i.e. “controlling” particular functions or processes).
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Dependent claims 4-9 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
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 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 2011/0009608 A1; previously cited) in view of Anderson et al (WO 02/44327 A2).
Regarding claim 1, Kim teaches an immunoassay device comprising:
A stage accommodating a cartridge having a plurality of wells that are capable of independently storing a solution containing magnetic particles (Fig. 7-8: multi-well plate; Abstract: automatic refining apparatus for separating target materials from a plurality of biological sample solution using magnetic particles);
A solution transfer unit comprising a tip that is movable relative to the stage and is configured to suction the solution stored in the wells or discharge the suctioned solution from the wells (Par. 15: a pipette block having a plurality of pipettes mounted in at least two rows for sucking and discharging samples);
A control unit configured to control the relative movement of the stage and the solution transfer unit, and the suction and discharge of the solution into and from the tip, respectively (Par. 81-82: functions of the immunoassay device are automatic and controlled by a control unit; Par. 15: a pipette block upward/downward moving means moving the pipette block upward and downward, and a pipette block forward/backward moving means moving the pipette block forward and backward);
Wherein the solution transfer unit comprises:
A driving part configured to provide a pressure for suctioning and discharging the solution into and from the tip, respectively (Par. 24: applying a discharge pressure to the pipette by a downward movement of a piston such that the solution is discharged from the pipette; Par. 61: upward and downward motion of the piston is used to effect suction and discharge of solution from the pipetter); and
A magnetic force applying part installed at one side of the tip to apply magnetic force toward the tip (Fig. 1-2, 191, 192; Par. 63; Par. 18: the magnetic field application unit may comprise a first row magnet mounting unit having a magnet for applying a magnetic field to the pipettes mounted on the first row of the pipette block. The magnetic field application unit further comprises a magnet mounting unit moving means),
Wherein the control unit is configured to control the driving part so that a magnitude of the magnetic force applied to the tip by the magnetic force applying part is adjusted to hold the magnetic particles inside the tip after the solution containing the magnetic particles is suctioned into the tip (Par. 15; Par. 18; Par. 81-82; Par. 11: collect and release magnetic microparticles through relative movement of the pipette and the magnet),
Wherein the magnetic force applying part comprises:
A magnet movable from a side surface of the tip toward or away from the tip, and a magnet moving part that is configured to allow the magnet to move in one direction (Par. 18: the magnetic field application unit comprises a magnet mounting unit moving means for controlling a distance between the magnet and the pipette).
Kim teaches that the diameter of the pipette relative to the size, position, shape, and strength of the magnet is an important design consideration for ensuring immobilization of magnetic particles without loss (Par. 105; Par. 62: if the magnetic particle collecting unit 142c has a large inner diameter, the magnetic particles at the opposite side of the magnet may flow downward without being attached to the inner wall. Thus, the magnetic particle collecting unit is formed to have such a radius that the magnetic particles passing through the opposite side of the magnet may also be collected).
Kim does not explicitly teach the device wherein the magnet has a shape that is fitted with a circumference of the tip, and wherein when viewed from an upper side of the tip, the magnet surrounds more than half of the circumference of the tip.
Regarding claim 1, Anderson teaches an immunoassay device (abstract) comprising:
A cylindrical channel for holding a solution comprising magnetic particles, wherein the magnetic particles may be immobilized by a magnetic field provided by a u-shaped magnet fitted with a circumference of the cylinder, and wherein when viewed from an upper side of the cylinder, the magnet surrounds more than half of the circumference of the tip (Fig. 29-30; Par. 197-200: an apparatus for manipulating magnetically responsive beads. The apparatus comprising vessel 282 which includes an outlet channel 300 and axial passage 302 extending between an outlet end 314 of channel 300 and well 290. A magnetic field generating device is positioned adjacent channel 300 for producing a magnetic field in axial passage 302. The magnetic field generating device may be a magnet 304 which can be a ring shaped or U-shaped magnet for surround a substantial portion of channel 300. The magnet is removable to interrupt the magnetic field from axial passage 302 to allow the beads to be removed or separated from channel 300).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Kim to further include U-shaped magnet fitted to a circumference of the tip (such that it would surround more than half of the circumference of the tip), as taught by Anderson. One of ordinary skill in the art would be motivated to make this modification because Kim teaches that the strength of the magnetic field across the entire diameter of the pipette is important for ensuring complete immobilization of the magnetic particles without loss, wherein the magnet must be close enough to all inner surfaces of the pipette to ensure a magnetic field with sufficient strength for immobilization, while Anderson teaches that immobilization of magnetic particles within a cylindrical channel may be achieved by a U-shaped magnet that wraps around the cylinder. As such, one of ordinary skill in the art would recognize that the U-shaped magnet taught by Anderson will ensure a stronger and more even magnetic field throughout the pipette, to facilitate immobilization of magnetic particles throughout the pipette. The U-shaped magnets are suitable in the device of Kim because they allow magnetic force to be applied around more than half the circumference of the pipette, while still allowing movement of the magnets towards and away from the pipettes. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Kim and Anderson are directed to immunoassay devices comprising magnets disposed around a cylindrical channel for the immobilization of magnetic particles.
Regarding claim 4, the U-shaped magnet fitted around a pipette tip of Kim in view of Anderson discussed above is understood to meet these limitations.
Regarding claim 5, neither Kim nor Anderson explicitly teaches the relative length of the magnet and the tip. Additionally, as discussed in the 112(b) section above, it is not clear exactly which dimensions of the magnet and the tip the term “length” is meant to refer to in this context.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used routine optimization to modify the magnet of Kim in view of Anderson such that it has a length greater than 80% or more than that of the tip because such optimization would increase the area of the tip to which the magnetic force is applied and would thereby increase the area and amount of magnetic particles which could be effectively immobilized by the magnet. One of ordinary skill in the art would have a reasonable expectation of making this modification because magnets of varying length employed in the device of Kim in view of Anderson would have predictable results on the functioning of the device and the immobilization of magnetic particles.
Regarding claim 6, Kim teaches the device wherein the tip is provided in plurality, the magnetic force applying part comprises a plurality of magnets, and the plurality of magnet is configured to independently move toward the plurality of tips or away from the plurality of tips (Par. 15: plurality of pipette tips; Par. 18: a first row magnet mounting unit and second row magnet mounting unit can move independently toward or away from the plurality of tips (wherein independent movement of each row of magnets, and independent movement of the magnets relative to other components of the apparatus are both understood to read on “the plurality of magnets is configured to independently move toward the plurality of tips or away from the plurality of tips”).
Regarding claim 7, Kim does not explicitly teach the device wherein the magnetic force applying part comprises an electromagnet that is adjustable in magnitude of the magnetic force.
Regarding claim 7, Anderson teaches that the magnetic force applying part may comprise an electromagnet (Par. 199: the magnet 304 may be an electromagnetic field that can be selectively activated and deactivated to provide the magnetic field as needed).
Anderson does not specifically teach that the electromagnet is adjustable in magnitude of the magnetic force, however, one of ordinary skill in the art would recognize that the magnitude of magnetic force of an electromagnet is adjustable based on the electric current applied, such that a generic electromagnet such as the one taught by Anderson is understood to be inherently adjustable in magnitude of the magnetic force.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Kim in view of Anderson to comprise an electromagnet, as taught by Anderson. Substitution of a permanent magnet for an electromagnet amounts to simple substitution of known elements to achieve predictable results with a reasonable expectation of success (i.e. both a permanent magnet and an electromagnet produce a magnetic force for retaining magnetic particles within the tip). Further, one would be motivated to use an electromagnet because it can be switched on and off and the magnitude of the magnetic force can be adjusted. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Kim and Anderson are directed to similar immunoassay devices comprising magnets used to immobilize magnetic particles within a cylindrical channel.
Regarding claim 8 Kim further teaches the device wherein the tip is provided in plurality and the driving part is configured to provide a pressure to each of the plurality of tips (Par. 15: a pipette block having a plurality of pipettes mounted in at least two rows for sucking and discharging samples; Par. 24: applying a discharge pressure to the pipette by a downward movement of a piston such that the solution is discharged from the pipette; Par. 61: upward and downward motion of the piston is used to effect suction and discharge of solution from each pipette).
Regarding claim 9, Kim further teaches the device wherein the driving part is configured to provide a pressure that generates a flow within the tip without discharging the solution to the outside of the tip (Par. 61: upward and downward motion of the piston is used to effect suction and discharge of solution from the pipette). Wherein suction is understood to generate a flow within the tip without discharging the solution to the outside of the tip.
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 and 4-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 12,399,189 B2 in view of Kim et al (US 2011/0009608 A1; previously cited) and Anderson et al (WO 02/44327 A2).
Regarding instant claims 1 and 6 the reference claims teach an immunoassay device comprising:
A stage accommodating a cartridge having a plurality of wells that are capable of independently storing a solution containing magnetic particles (reference claim 1);
A solution transfer unit comprising a plurality of tips that is movable relative to the stage and is configured to suction the solution stored in the wells or discharge the suctioned solution from the wells (reference claim 1);
A control unit configured to control the relative movement of the stage and the solution transfer unit, and the suction and discharge of the solution into and from the tip, respectively (reference claim 1 teaches that the solution transfer unit is configured to move relative to the stage, which implies the presence of a control unit to facilitate the movement);
Wherein the solution transfer unit comprises:
A driving part configured to provide a pressure for suctioning and discharging the solution into and from the tip, respectively (reference claim 1 teaches that the solution transfer unit is configured to suction and discharge solution stored in the wells, which implies the presence of a means (i.e. driving part) which provides the required pressure to facilitate this function);
A magnetic force applying part installed at one side of the tip to apply magnetic force toward the tip (reference claim 4).
Reference claim 4 further teaches that the magnetic force applying part is capable of applying magnetic force toward the tip for immobilization of magnetic particles inside the tip.
The reference claims do not explicitly teach the following limitations:
Wherein the control unit is configured to control the driving part so that a magnitude of the magnetic force applied to the tip by the magnetic force applying part is adjusted to hold the magnetic particles inside the tip after the solution containing the magnetic particles is suctioned into the tip;
Wherein the magnetic force applying part comprises:
A magnet movable from a side surface of the tip toward the tip or away from the tip;
A magnet moving part that is configured to allow the magnet to move in one direction;
Wherein the magnet has shape that is fitted with a circumference of the tip and when viewed from an upper side of the tip, the magnet surrounds more than half of the circumference of the tip.
Regarding instant claims 1 and 6, Kim teaches an immunoassay device comprising:
A stage accommodating a cartridge having a plurality of wells that are capable of independently storing a solution containing magnetic particles (Fig. 7-8: multi-well plate; Abstract: automatic refining apparatus for separating target materials from a plurality of biological sample solution using magnetic particles);
A solution transfer unit comprising a tip that is movable relative to the stage and is configured to suction the solution stored in the wells or discharge the suctioned solution from the wells (Par. 15: a pipette block having a plurality of pipettes mounted in at least two rows for sucking and discharging samples);
A control unit configured to control the relative movement of the stage and the solution transfer unit, and the suction and discharge of the solution into and from the tip, respectively (Par. 81-82: functions of the immunoassay device are automatic and controlled by a control unit; Par. 15: a pipette block upward/downward moving means moving the pipette block upward and downward, and a pipette block forward/backward moving means moving the pipette block forward and backward);
Wherein the solution transfer unit comprises:
A driving part configured to provide a pressure for suctioning and discharging the solution into and from the tip, respectively (Par. 24: applying a discharge pressure to the pipette by a downward movement of a piston such that the solution is discharged from the pipette; Par. 61: upward and downward motion of the piston is used to effect suction and discharge of solution from the pipetter); and
A magnetic force applying part installed at one side of the tip to apply magnetic force toward the tip (Fig. 1-2, 191, 192; Par. 63; Par. 18: the magnetic field application unit may comprise a first row magnet mounting unit having a magnet for applying a magnetic field to the pipettes mounted on the first row of the pipette block. The magnetic field application unit further comprises a magnet mounting unit moving means),
Wherein the control unit is configured to control the driving part so that a magnitude of the magnetic force applied to the tip by the magnetic force applying part is adjusted to hold the magnetic particles inside the tip after the solution containing the magnetic particles is suctioned into the tip (Par. 15; Par. 18; Par. 81-82; Par. 11: collect and release magnetic microparticles through relative movement of the pipette and the magnet),
Wherein the magnetic force applying part comprises:
A magnet movable from a side surface of the tip toward or away from the tip, and a magnet moving part that is configured to allow the magnet to move in one direction; wherein the magnetic force applying part comprises a plurality of magnets and the plurality of magnets is configured to independently move toward the plurality of tips or away from the plurality of tips (Par. 18: the magnetic field application unit comprises a magnet mounting unit moving means for controlling a distance between the magnet and the pipette; Par. 18: a first row magnet mounting unit and second row magnet mounting unit can move independently toward or away from the plurality of tips (wherein independent movement of each row of magnets, and independent movement of the magnets relative to other components of the apparatus are both understood to read on “the plurality of magnets is configured to independently move toward the plurality of tips or away from the plurality of tips”).
Kim teaches that the diameter of the pipette relative to the size, position, shape, and strength of the magnet is an important design consideration for ensuring immobilization of magnetic particles without loss (Par. 105; Par. 62: if the magnetic particle collecting unit 142c has a large inner diameter, the magnetic particles at the opposite side of the magnet may flow downward without being attached to the inner wall. Thus, the magnetic particle collecting unit is formed to have such a radius that the magnetic particles passing through the opposite side of the magnet may also be collected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of the reference claims to further comprise the control unit for controlling the driving part and the magnetic force applying part as taught by Kim. One of ordinary skill in the art would be motivated to make this modification to allow for automated control and movement of the magnets of the magnetic force applying part in order to allow modulation and adjustment of the magnetic force applied to the tip in order to immobilize or release magnetic particles within the tip. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Kim are directed to immunoassay devices comprising magnetic force applying parts used to immobilize magnetic particles within a pipette tip.
Regarding instant claims 1 and 6, Anderson teaches an immunoassay device (abstract) comprising:
A cylindrical channel for holding a solution comprising magnetic particles, wherein the magnetic particles may be immobilized by a magnetic field provided by a u-shaped magnet fitted with a circumference of the cylinder, and wherein when viewed from an upper side of the cylinder, the magnet surrounds more than half of the circumference of the tip (Fig. 29-30; Par. 197-200: an apparatus for manipulating magnetically responsive beads. The apparatus comprising vessel 282 which includes an outlet channel 300 and axial passage 302 extending between an outlet end 314 of channel 300 and well 290. A magnetic field generating device is positioned adjacent channel 300 for producing a magnetic field in axial passage 302. The magnetic field generating device may be a magnet 304 which can be a ring shaped or U-shaped magnet for surround a substantial portion of channel 300. The magnet is removable to interrupt the magnetic field from axial passage 302 to allow the beads to be removed or separated from channel 300).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by the reference claims in view of Kim to further include U-shaped magnet fitted to a circumference of the tip (such that it would surround more than half of the circumference of the tip), as taught by Anderson. One of ordinary skill in the art would be motivated to make this modification because Kim teaches that the strength of the magnetic field across the entire diameter of the pipette is important for ensuring complete immobilization of the magnetic particles without loss, wherein the magnet must be close enough to all inner surfaces of the pipette to ensure a magnetic field with sufficient strength for immobilization, while Anderson teaches that immobilization of magnetic particles within a cylindrical channel may be achieved by a U-shaped magnet that wraps around the cylinder. As such, one of ordinary skill in the art would recognize that the U-shaped magnet taught by Anderson will ensure a stronger and more even magnetic field throughout the pipette, to facilitate immobilization of magnetic particles throughout the pipette. The U-shaped magnets are suitable in the device of the reference claims in view of Kim because they allow magnetic force to be applied around more than half the circumference of the pipette, while still allowing movement of the magnets towards and away from the pipettes. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the reference claims, Kim, and Anderson are directed to immunoassay devices comprising magnets disposed around a cylindrical channel for the immobilization of magnetic particles.
Regarding instant claim 4, the U-shaped magnets of the reference claims in view of Kim and Anderson are understood to meet the limitations of claim 4.
Regarding instant claim 5, neither the reference claims nor Kim nor Anderson explicitly teaches the relative length of the magnet and the tip. Additionally, as discussed in the 112(b) section above, it is not clear exactly which dimensions of the magnet and the tip the term “length” is meant to refer to in this context.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used routine optimization to modify the magnet of the reference claims in view of Kim and Anderson such that it has a length greater than 80% or more than that of the tip because such optimization would increase the area of the tip to which the magnetic force is applied and would thereby increase the area and amount of magnetic particles which could be effectively immobilized by the magnet. One of ordinary skill in the art would have a reasonable expectation of making this modification because magnets of varying length employed in the device of the reference claims in view of Kim and Anderson would have predictable results on the functioning of the device and the immobilization of magnetic particles.
Regarding instant claim 7, neither the reference claims nor Kim specifically teach the device wherein the magnetic force applying part comprises an electromagnet that is adjustable in magnitude of the magnetic force.
Regarding instant claim 7, Anderson teaches that the magnetic force applying part may comprise an electromagnet (Par. 199: the magnet 304 may be an electromagnetic field that can be selectively activated and deactivated to provide the magnetic field as needed).
Anderson does not specifically teach that the electromagnet is adjustable in magnitude of the magnetic force, however, one of ordinary skill in the art would recognize that the magnitude of magnetic force of an electromagnet is adjustable based on changes to the electric current, such that a generic electromagnet such as the one taught by Anderson is understood to be inherently adjustable in magnitude of the magnetic force.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of the reference claims in view of Kim and Anderson to comprise an electromagnet, as taught by Anderson. Substitution of a permanent magnet for an electromagnet amounts to simple substitution of known elements to achieve predictable results with a reasonable expectation of success (i.e. both a permanent magnet and an electromagnet produce a magnetic force for retaining magnetic particles within the tip). Further, one would be motivated to use an electromagnet because it can be switched on and off and the magnitude of the magnetic force can be adjusted. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because the reference claims, Kim, and Anderson are directed to immunoassay devices comprising magnets used to immobilize magnetic particles within a cylindrical channel.
All additional limitations of instant claim 8 are taught by reference claim 1.
All additional limitations of instant claim 9 are taught by reference claim 1, wherein suctioning of a solution is understood to provide a pressure that generates a flow within the tip without discharging the solution to the outside of the tip.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 4-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of copending Application No. 17/598,653 in view of Kim et al (US 2011/0009608 A1; previously cited) and Anderson et al (WO 02/44327 A2). .
Regarding instant claims 1 and 6, all limitations of the instant claim are taught by reference claims 1 and 5-7, with the exception that the reference claims do not teach that the magnetic force applying part comprises: a magnet movable from a side surface of the tip toward the tip or away from the tip; and a magnet moving part that is configured to allow the magnet to move in one direction, and wherein the magnet has a shape that is fitted with a circumference of the tip, and when viewed from an upper side of the tip, the magnet surrounds more than half of the circumference of the tip. The reference claims do not specifically teach the magnetic force applying part comprising a plurality of magnets wherein the plurality of magnet is configured to independently move toward the plurality of tips or away from the plurality of tips.
The reference claims teach a solution transfer unit comprising a magnetic force applying part for immobilizing magnetic particles in the tip, but does not explicitly teach further structure of the magnetic force applying part.
Regarding instant claims 1 and 6, Kim teaches an immunoassay device similar to the one claimed in both the reference claims and the instant claims, and teaches the device comprising the magnetic force applying part comprises: a magnet movable from a side surface of the tip toward the tip or away from the tip; and a magnet moving part that is configured to allow the magnet to move in one direction. Kim teaches that the magnetic force applying part comprises a plurality of magnets, wherein the plurality of magnets is configured to independently move toward the plurality of tips or away from the plurality of tips (Par. 18: the magnetic field application unit comprises a magnet mounting unit moving means for controlling a distance between the magnet and the pipette; Par. 18: a first row magnet mounting unit and second row magnet mounting unit can move independently toward or away from the plurality of tips (wherein independent movement of each row of magnets, and independent movement of the magnets relative to other components of the apparatus are both understood to read on “the plurality of magnets is configured to independently move toward the plurality of tips or away from the plurality of tips”).
Kim teaches that the diameter of the pipette relative to the size, position, shape, and strength of the magnet is an important design consideration for ensuring immobilization of magnetic particles without loss (Par. 105; Par. 62: if the magnetic particle collecting unit 142c has a large inner diameter, the magnetic particles at the opposite side of the magnet may flow downward without being attached to the inner wall. Thus, the magnetic particle collecting unit is formed to have such a radius that the magnetic particles passing through the opposite side of the magnet may also be collected).
Kim does not explicitly teach the device wherein the magnet has a shape that is fitted with a circumference of the tip, and wherein when viewed from an upper side of the tip, the magnet surround more than half of the circumference of the tip.
Regarding claim 1, Anderson teaches an immunoassay device (abstract) comprising:
A cylindrical channel for holding a solution comprising magnetic particles, wherein the magnetic particles may be immobilized by a magnetic field provided by a u-shaped magnet fitted with a circumference of the cylinder, and wherein when viewed from an upper side of the cylinder, the magnet surrounds more than half of the circumference of the tip (Fig. 29-30; Par. 197-200: an apparatus for manipulating magnetically responsive beads. The apparatus comprising vessel 282 which includes an outlet channel 300 and axial passage 302 extending between an outlet end 314 of channel 300 and well 290. A magnetic field generating device is positioned adjacent channel 300 for producing a magnetic field in axial passage 302. The magnetic field generating device may be a magnet 304 which can be a ring shaped or U-shaped magnet for surround a substantial portion of channel 300. The magnet is removable to interrupt the magnetic field from axial passage 302 to allow the beads to be removed or separated from channel 300).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by the reference claims to further include the specific magnetic force applying part taught by Kim and to modify the magnets of Kim to further include U-shaped magnet fitted to a circumference of the tip, and wherein when viewed from an upper side of the tip, the magnet surrounds more than half of the circumference of the tip, as taught by Anderson. One of ordinary skill in the art would be motivated to use the specific magnetic force applying part taught by Kim which comprises a magnet movable from a side surface of the tip towards the tip or away from the tip and a magnet moving part that is configured to allow the magnet to move in one direction because the reference claims teach a magnetic force applying part used to immobilize magnetic particles inside a pipette, but is generic regarding its particular construction, while Kim discloses a magnetic force applying part which comprises magnets which can be moved closer to or away from a pipette in order to facilitate the immobilization of magnetic particles inside the pipette. One of ordinary skill in the art would recognize that it is advantageous to be able to move the magnetic force applying part in this way in order to modulate the magnetic force applied to the pipette tip. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Kim are directed to immunoassay devices that facilitate the immobilization of magnetic particles in a pipette tip.
One of ordinary skill in the art would be motivated to further modify the shape of the magnets to comprise the U-shape magnets taught by Anderson, (such that they would surround more than half of the circumference of the tip). One would make this modification because Kim teaches that the strength of the magnetic field across the entire diameter of the pipette is important for ensuring complete immobilization of the magnetic particles without loss, wherein the magnet must be close enough to all inner surfaces of the pipette to ensure a magnetic field with sufficient strength for immobilization, while Anderson teaches that immobilization of magnetic particles within a cylindrical channel may be achieved by a U-shaped magnet that wraps around the cylinder. As such, one of ordinary skill in the art would recognize that the U-shaped magnet taught by Anderson will ensure a stronger and more even magnetic field throughout the pipette, to facilitate immobilization of magnetic particles thr