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, 3-21, 23-26, 28-29, and 31 are pending in the application.
Claims 16-20 are withdrawn.
Claims 1, 3-15, 21, 23-26, 28-29, and 31 are the subject of this office action.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 requires that the bead is directly linked to both the catalytic self-propulsion micro/nanoparticle and the functional material.
Dependent claim 23 indicates that the functional material is bound to an AuNP. Together with claim 1, this means that either the AuNP is the bead (which does not appear to be the case because it is not stated or made clear by the claims), or that the functional material is in some way bound to both the AuNP and the bead.
Dependent claim 24 further recites that the second portion of the surface of the plurality of beads is coated with at least a portion of the AuNP, which definitively excludes the possibility that the AuNP is the bead. This then means that claims 23-24 require that the functional material is both bound to the AuNP and directly linked to the plurality of beads.
It is not clear exactly how or why this would be functional, and there is no recitation of this embodiment in the disclosure as originally filed. Regarding incorporation of AuNPs, the specification only provides examples such as those discussed in Par. 113 and 119 of the instant specification. These comprise spherical polystyrene (PS) beads which are coated with PtNPs and AuNP, wherein the AuNPs are functionalized with DNA probes (i.e. functional material) prior to their addition to the PS beads. This creates a structure where the bead is directly linked to the catalytic self-propulsion micro/nanoparticle, but indirectly linked to the functional material (because the functional material is attached to the AuNP and the AuNP is attached to the PS bead, such that there is an intermediate element between the functional material and the bead). As such, these embodiments fail to fulfill the limitations of claim 1. This is a new matter rejection of claims 23-24 and 26.
Claim Rejections - 35 USC § 112(d)
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.
Claim 15 is 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.
Claim 15 is directed to a system and depends from the system of claim 1, wherein a system is defined by its structural features and physical component. Claim 15 does not further limit the system of claim 1 because it imposes limitations on the types of samples intended to be used with the system and not on the structure of the system itself.
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 § 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, 11-15, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 2014/0045179; IDS entered) in view of Yu et al (Motor-based autonomous microsensor for motion and counting immunoassay of cancer biomarker. Anal Chem. 2014 May 6;86(9):4501-7. Epub 2014 Apr 23; Previously cited).
Regarding claims 1, 21 and 23, Wang teaches:
A sample testing unit configured to house a sample (Par. 102: lab on a chip device capable of housing samples), comprising:
A plurality of catalytic self-propulsion micro/nanoparticles (Par. 102: microtube rocket 1100 engineered to self-propel in a fluid; Par. 52: the microtubular engine can include a platinum layer that can catalyze a fuel and generate propulsion; Fig. 5B, 17);
A functional material specific for a target analyte (Par. 99: the functionalized microstructures can be functionalized with ligan biomolecules such as antibodies, nucleic acids, aptamers, lectins, etc., that have an affinity to receptor molecules, e.g. independent target biomolecules or target biomolecules on living cells; Fig. 1);
Wang teaches that the disclosed microrockets (i.e. plurality of catalytic self-propulsion micro/nanoparticles) may comprise an external gold layer which may be thiolated to facilitate functionalization of the gold layer with an antibody functional material (Par. 70: gold layer applied to platinum microtubes facilitates functionalization, e.g. with the antibody receptor through the assembly of alkanethiols).
Wang therefore teaches a gold surface wherein the plurality of catalytic self-propulsion micro/nanoparticles is directly linked to a first portion of the gold surface and the functional material is linked directly to a second portion of the gold surface, wherein the gold surface is thiolated.
Wang differs from the instant claim in that it does not teach the plurality of beads as claimed.
Similar to Wang, Yu discloses a system comprising microrockets (i.e. plurality of catalytic self-propulsion micro/nanoparticles) which comprise an outer layer of gold functionalized with a functional material such as an antibody (Scheme 1). Yu teaches that the outer gold surface of the microrocket functionalized with the antibody may comprise a plurality of gold NPs functionalized with antibodies, as shown in Scheme 1 (wherein a plurality of AuNPs is understood to read on a plurality of beads).
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 system of Wang to replace the functionalized gold surface taught by Wang with the plurality of functionalized AuNPs (i.e. plurality of beads) taught by Yu because modification of the gold surface functionalized with antibodies of Wang for gold NPs functionalized with antibodies amounts to simple substitution of known elements to achieve predictable results with a reasonable expectation of success. Further, one of ordinary skill in the art would be motivated to make this modification because the plurality of AuNPs provides increased surface area for functionalization as compared to the gold surface taught by Wang. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both Wang and Yu are directed to systems comprising microrockets which are directly linked to a gold surface which is functionalized with a functional material such as an antibody.
Thus in the modified invention of Wang in view of Yu, the plurality of catalytic self-propulsion micro/nanoparticles (i.e. microrockets) is directly linked to a first portion of a surface of each of a plurality of beads (i.e. thiolated AuNPs) and a functional material is directly linked to a second portion of the surface of the plurality of beads.
Wang further teaches the system comprising an optical recording unit comprising an optical arrangement configured to detect a movement of the plurality of beads in the sample testing unit (Par. 120: exemplary videos were captured using CoolSNAP HQ2 camera).
Regarding the limitation “wherein the movement of the beads is indicative of a presence or an absence of the target analyte”, this is noted to be a recitation of intended use (i.e. the detection of the presence or absence of a target analyte based on the motion behavior of the beads is an intended use of the claimed system. The recitation appears as a limitation of the configuration of the optical recording unit, which defines how the optical recording unit is intended to be used and what it is intended to detect. A recitation of intended use does not distinguish over the prior art since a system claim such as claim 1 covers the structural components of the system and not what it is used for. Therefore, as long as the prior art teaches the structural limitations of the claimed features, it reads on the claim. See MPEP 2114 and 2115. This is also true if the limitation is interpreted as a functional limitation, wherein the functional features of the claimed optical recording unit are understood to be a product of the structural features that define the system/optical recording unit. In this case, Wang teaches all structural components and limitations of the claimed system, as described above, and teaches an optical recording unit which is capable of detecting the motion behavior of the beads in the sample testing unit. Thus, the optical recording unit taught by Wang is capable of performing the recited intended use and is sufficient to meet the structural limitations of the instant claim.
Regarding claim 11, Wang further teaches the system wherein at least one of the catalytic self-propulsion micro/nanoparticles moves by at least one of self-electrophoresis, self-diffusiophoresis, or bubble thrust (Abstract: an inner layer having a catalyst material that is reactive with a fuel fluid to produce bubbles exiting the tube from the large opening to propel the tube to move in the fuel fluid)
Regarding claim 12, Wang further teaches the system wherein at least one of the catalytic self-propulsion micro/nanoparticles comprises Au, Cu, Fe, Pd, Zn, Cd, Ag, or Pt (Par. 116: the motor structure may comprise Au, Ti, Ni, Pt, and/or Fe).
Regarding claim 13, Wang further teaches the system wherein at least one of the catalytic self-propulsion micro/nanoparticles comprises a spherical shape, a wire shape, a rod shape, a tube shape, or a helix shape (Par. 6: a device that self propels in a fuel fluid includes a tube structured to include a first and second opening).
Regarding claim 14, Wang further teaches the system wherein the functional material comprises an antibody, a nucleic acid amplicon, a DNA probe, an RNA probe, an aptamer, a protein, an intact virus, a vesicle, or a cell (Par. 99: the functionalized microstructures can be functionalized with ligand biomolecules such as antibodies, nucleic acids, aptamers, lectins, etc., that have an affinity to receptor molecules e.g. independent target biomolecules or target biomolecules on living cells).
Regarding claim 15, Wang further teaches the system wherein the sample includes at least one of a biological sample, a chemical sample, or an environmental sample (Par. 47: exemplary samples can include biological fluids, or non-biological fluids such as (but not limited to), water, saltwater, sugar water, juice, and oil-based fluids).
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 2014/0045179, IDS entered) in view of Yu et al (Motor-based autonomous microsensor for motion and counting immunoassay of cancer biomarker. Anal Chem. 2014 May 6;86(9):4501-7. Epub 2014 Apr 23.; previously cited), as applied to claim 1 above, further in view of D’Ambrosio et al (D'Ambrosio MV, Bakalar M, Bennuru S, Reber C, Skandarajah A, Nilsson L, Switz N, Kamgno J, Pion S, Boussinesq M, Nutman TB, Fletcher DA. Point-of-care quantification of blood-borne filarial parasites with a mobile phone microscope. Sci Transl Med. 2015 May 6;7(286):286re4.; previously cited).
Regarding claims 3-4 and 8, Wang teaches the system of claim 1, but does not specifically teach the system wherein the optical recording unit further comprises a handheld device comprising a processor and configured for display of a visualization.
D’Ambrosio is directed to point-of-care (POC) quantification of blood-borne filarial parasites with a mobile phone microscope.
Regarding claims 3-4 and 8, D’Ambrosio teaches a biodetection system (Abstract) comprising a handheld device (a cellphone) comprising a processor and configured for display of a visualization, and teaches that the handheld device is configured to create the visualization as a video (Abstract: a POC device comprising a mobile phone-based video microscope (wherein a smartphone with a portable microscope attachment such as the one used is understood to be a handheld device comprising a processor, and wherein a video microscope is understood to be capable of creating a visualization as a video of the motion behavior) for capturing and analyzing videos of microfilarial motion in whole blood using motorized sample scanning and onboard motion detection, minimizing input from health care workers and providing quantification in less than two minutes; Fig. 1-2).
The limitations “to determine the presence or absence of a target analyte” and “to create a video of the motion behavior” are noted to be recitations of intended use. A recitation of intended use does not distinguish over the prior art since a system claim such as claim 3 or claim 8 which covers the structural components of the system and not what it is used for. Therefore, as long as the prior art teaches the structural limitations of the claimed feature, it reads on the claim. See MPEP 2114 and 2115. In the instant case, Wang in view of D’Ambrosio teaches all the structural features of the instant claims and includes an optical component comprising a handheld device comprising a processor which is capable of configuring display of a visualization to determine the presence or the absence of the target analyte, wherein the visualization is a video of the motion behavior (i.e. the mobile phone-based video microscope of D’Ambrosio is understood to be capable of performing the recited function), and therefore is sufficient to meet the instant claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Wang to include an optical recording unit specifically comprising a handheld device (a cellphone) comprising a processor and configured for display of a visualization, as taught by D’Ambrosio. Wang teaches that many immunoassays are inhibited by the necessitation of expensive specialized equipment and tedious processes, and teaches that point-of-care (POC) devices are advantageous because they can be used to implement various tests for a variety of clinical applications, in a variety of environments (Par. 4). Wang further discloses a detection device wherein detection of microscale components can be imaged and visualized using a microscope and a camera and/or fluorescence detection (Fig. 29; Par. 160; Par. 76; Par. 67). D’Ambrosio teaches that a smartphone camera can be adapted for microscopy and is capable of recording and displaying visualizations of microscale biological components at a resolution that is suitable for quantitative bio-detection processes (Abstract; Fig. 1-2). One of ordinary skill in the art would be motivated to modify the system taught by Wang to include the smartphone optical component taught by D’Ambrosio in order to provide a POC method of imaging which utilizes a cellphone rather than requiring the use of expensive specialized equipment. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Wang is directed to a detection device comprising microscale components which can be viewed with an optical recording unit, and D’Ambrosio teaches that a smartphone is an optical recording unit capable of imaging biological components at a microscale.
Regarding claim 5, Wang in view of D’Ambrosio teaches the system of claim 3, Wang does not specifically teach the system wherein the sample testing unit comprises an attachment for the handheld device and a device configured to house the sample and fit within the attachment, wherein the handheld device is configured to utilize the optical recording unit to detect the motion behavior of the beads within a portion of the device.
Regarding claim 5, D’Ambrosio teaches a system wherein a sample testing unit comprises an attachment for the handheld device and a device configured to house the sample and fit within the attachment and wherein the handheld device is configured to use the optical component to detect the motion behavior of the beads within a portion of the device (Fig. 2 shows a handheld device (cellphone comprising a cellphone camera) inserted into an attachment which comprises a device configured to house the sample within the attachment and wherein the cellphone camera used in conjunction with the attachment can detect the motion behavior of the beads within a portion of the device)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wang in view of D’Ambrosio to further include the attachment for the handheld device and a device configured to house the sample and fit within the attachment, as taught by D’Ambrosio (Fig. 2). Wang teaches that many immunoassays are inhibited by the necessitation of expensive specialized equipment and tedious processes, and teaches that point-of-care (POC) devices are advantageous because they can be used to implement various tests for a variety of clinical applications, in a variety of environments (Par. 4). Wang further discloses a detection device wherein detection of microscale components can be imaged and visualized using a microscope and a camera and/or fluorescence detection (Fig. 29; Par. 160; Par. 76; Par. 67). D’Ambrosio teaches that a cellphone camera can be adapted for video microscopy for quantitative detection and imaging of microscale biological components, and teaches the use of an attachment which receives the cellphone and houses the sample, and which serves to hold both the phone and the sample in a constant and steady position for imaging (Abstract; Fig. 2). One of ordinary skill in the art would be motivated to make this modification in order to provide a POC method of imaging which utilizes a cellphone rather than requiring the use of expensive specialized equipment, and to provide an attachment platform which allows for consistent and steady imaging. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Wang is directed to a detection device comprising microscale components which can be viewed with an optical recording unit, and D’Ambrosio teaches that a smartphone is an optical recording unit capable of imaging biological components at a microscale. Additionally, Wang teaches that the detection system can comprise a lab-on-a-chip format, wherein a portable chip is understood to be suitable for insertion into an attachment for housing a sample (Par. 102).
Regarding claim 6-7, Wang in view of D’Ambrosio teaches the system of claim 5, and Wang further teaches the system wherein the device comprises a microchip with at least one channel for loading the sample with the plurality of beads and the plurality of motor structures (Par. 102: exemplary integration of the functionalized micromotors in a complete lab-on-chip device; Par. 104: the microrockets with the captured target nucleic acid can be propelled through an exemplary microchannel towards a detection zone). Regarding claim 8, the microchip taught by Wang is understood to facilitate the display of the visualization as a video of the motion behavior insofar as it receives a sample and localizes it into a concentrated area which can be easily visualized by the cellphone video-microscope taught by Wang in view of D’Ambrosio.
The limitation “for loading the sample with the plurality of beads and the plurality of motor structures is understood to be a recitation of intended use. Though Wang does recite a microchip with a channel for this intended use (receiving a sample), it is noted that a recitation of intended use does not distinguish over the prior art since a system claim such as claim 6 or claim 7 covers the structural components of the system and not what it is used for. Therefore, as long as the prior art teaches the structural limitations of the claimed feature, it reads on the claim. See MPEP 2114 and 2115. In the instant case, Wang in view of D’Ambrosio teaches all the structural components of the claimed system, and teaches structural components which are capable of performing the recited function (i.e. the microchip comprising at least one channel as taught by Wang is capable of loading a sample with a plurality of beads and a plurality of motor structures, and therefore is sufficient to meet the instant claim.
Subject Matter Free of Prior Art
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 28-29 and 31 are allowed.
Regarding claims 9-10, the closest prior art is Wang et al (US 2014/0045179; IDS entered) in view of Yu et al (Motor-based autonomous microsensor for motion and counting immunoassay of cancer biomarker. Anal Chem. 2014 May 6;86(9):4501-7. Epub 2014 Apr 23; Previously cited), as discussed in the rejection of independent claim 1 above.
Wang and Yu differ from claims 9-10 in the Wang in view of Yu specifically teaches that the plurality of beads are gold nanoparticles and therefore do not read on the microbeads recited in claims 9-10. Neither Wang nor Yu provides motivation for modifying the nanoparticles to instead comprise microparticles, and as such it would not be obvious to one of ordinary skill in the art to modify Wang in view of Yu to meet the limitations or claims 9-10.
Regarding independent claim 28, the closest prior art Wang et al (US 2014/0045179; IDS entered) and Yu et al (Motor-based autonomous microsensor for motion and counting immunoassay of cancer biomarker. Anal Chem. 2014 May 6;86(9):4501-7. Epub 2014 Apr 23; Previously cited).
Regarding claim 28, Yu teaches a system comprising:
A sample testing unit configured to house a sample (Pg. 4503, Col. 2, Par. 2: samples and microsensors mixed on a slide) comprising:
A plurality of catalytic self-propulsion micro/nanoparticles (Scheme 1; Pg. 4502, Col. 2, last Par.: polymer-metal bilayer micromotors comprising a Pt core);
A functional material specific for a target analyte (Scheme 1: Ab1 conjugated to an outer layer of the motor structure);
A plurality of beads (Scheme 1: AuNPs);
Wherein the plurality of catalytic self-propulsion micro/nanoparticles is directly linked to the plurality of beads and the functional material is directly linked to the plurality of beads (Scheme 1: shows AuNPs conjugated to Ab1 and coated on the surface of the catalytic self-propulsion particle; Pg. 4503, Col. 2, Par. 3: After the PANI/Pt micromotor was sequentially incubated with the oppositely charged PSS and PDDA polyelectrolytes, the outer surface of the PANI/Pt micromotor was capped with positive charge, which facilitated the adsorption of the negatively charged citrate-wrapped AuNPs by electrostatic interactions; wherein charge interactions facilitated by citrate wrapping AuNPs also facilitate direct adsorption of the antibody Ab1 to the AuNPs); and
An optical recording unit comprising an optical arrangement configured to detect the movement of the beads in the sample testing unit (Pg. 4502, Col. 2).
Regarding the limitation “a movement of the beads in the sample testing unit that indicate the presence of the target analyte”, this is noted to be a recitation of intended use (i.e. the detection of the presence or absence of a target analyte based on the motion behavior of the beads is an intended use of the claimed system). The recitation appears as a limitation of the configuration and capabilities of the optical recording unit, which defines how the optical recording unit is intended to be used and what it is intended to detect. A recitation of intended use does not distinguish over the prior art since a system claim such as claim 28 covers the structural components of the system and not what it is used for. Therefore, as long as the prior art teaches the structural limitations of the claimed features, it reads on the claim. See MPEP 2114 and 2115. This is also true if the limitation is interpreted as a functional limitation, wherein the functional features of the claimed optical recording unit are understood to be a product of the structural features that define the system/optical recording unit. In this case, Yu teaches all the structural components and limitations of the claimed system as described above, and teaches an optical recording unit which is capable of detecting the motion behavior of the beads in the sample testing unit. Thus, the optical recording unit taught by Yu is capable of performing the recited intended use and is sufficient to meet the structural limitations of the instant claim.
Further, Yu does explicitly teach the system wherein movement of the beads is indicative of the presence of absence of the target analyte (Pg. 4502, Col. 1: in the presence of target protein, the Ab2-GMA could quickly bind to the surface of the moving microsensor via the formation of a sandwich complex (Scheme 1B). The loading of microsize GMA tags on the microsensor slowed down its movement, resulting in a decrease of motion speed).
Yu differs from instant claim 28 in that it does not teach the system wherein the plurality of beads is thiolated and it does not teach that the plurality of beads is indirectly coated with at least a portion of the functional material
Though thiolation of gold surfaces for antibody conjugation is well-known in the art, Yu resists modification which would replace its disclosed citrate capping of the AuNP with thiolation of the AuNP because the specific charge interaction produced by citrate capping the AuNP is what facilitates direct linkage of the AuNP to both the polyelectrolyte coated micromotor and the functional material (antibody). Additionally, the prior art does not provide motivation to modify Yu such that the plurality of beads is indirectly coated with the functional material rather than directly coated with the functional material.
Regarding claim 28, Wang teaches a system comprising:
A sample testing unit configured to house a sample (Par. 102: lab on a chip device capable of housing samples), comprising:
A plurality of catalytic self propulsion micro/nanoparticles (Par. 102: microtube rocket 1100 engineered to self-propel in a fluid; Par. 52: the microtubular engine can include a platinum layer that can catalyze a fuel and generate propulsion; Fig. 5B, 17);
A functional material specific for a target analyte (Par. 99: the functionalized microstructures can be functionalized with ligand biomolecules such as antibodies, nucleic acids, aptamers, lectins, etc., that have an affinity to receptor molecules e.g. independent target biomolecules or target biomolecules on living cells; Fig. 1);
A plurality of beads (Par. 93: a Pt-Ni-Au microengine incorporating a ferromagnetic Ni layer loads a spherical cargo (bead) and transports it via self-propulsion; Par. 160: a microengine conjugated to a functional material for a target analyte is also attached to and moves a magnetic polymeric bead)
Wherein the plurality of beads is directly coated with at least a portion of the plurality of catalytic self propulsion micro/nanoparticles (i.e. magnetic loading of the cargo bead to the microengine such that the bead is directly coated with the microengine) and indirectly coated with at least a portion of the functional material (i.e. indirect connection or coating created by joining of the cargo bead and the microengine (wherein the microengine is coated with functional material)).
An optical recording unit comprising an optical arrangement configured to detect the movement of the beads in the sample testing unit (Par. 120: exemplary videos were captured using CoolSNAP HQ2 camera).
Regarding the limitation “a movement of the beads in the sample testing unit that indicate presence of the target analyte”, this is noted to be a recitation of intended use (i.e. the detection of the presence or absence of a target analyte based on the motion behavior of the beads is an intended use of the claimed system). The recitation appears as a limitation of the configuration and capabilities of the optical recording unit, which defines how the optical recording unit is intended to be used and what it is intended to detect. A recitation of intended use does not distinguish over the prior art since a system claim such as claim 28 covers the structural components of the system and not what it is used for. Therefore, as long as the prior art teaches the structural limitations of the claimed features, it reads on the claim. See MPEP 2114 and 2115. This is also true if the limitation is interpreted as a functional limitation, wherein the functional features of the claimed optical recording unit are understood to be a product of the structural features that define the system/optical recording unit In this case, Wang teaches all the structural components and limitations of the claimed system as described above, and teaches an optical recording unit which is capable of detecting the motion behavior of the beads in the sample testing unit. Thus, the optical recording unit taught by Wang is capable of performing the recited intended use and is sufficient to meet the structural limitations of the instant claim.
Wang differs from instant claim 28 in that it does not teach the system wherein the plurality of beads is thiolated.
Wang resists modification to meet the limitation that the plurality of beads is thiolated because Wang teaches that the plurality of beads are simply magnetic spherical cargo beads which are not functionalized (because the functional material in Wang is directly linked to the microengine and not to the bead). As such, there is no motivation for modifying the plurality of magnetic beads taught by Wang such that they are thiolated because the plurality of beads are not functionalized in the invention of Wang.
Response to Arguments
Applicant’s arguments filed 8 December 2025 have been fully considered.
Regarding previously applied 112(f) interpretation, applicant’s amendment of the claims has rendered this interpretation moot, and claims are no longer interpretated under 112(f).
Regarding the previous 112(b) rejections, applicant’s amendments have overcome the 112(b) rejections and all previous 112(b) rejections are withdrawn.
Regarding the 102 and 103 rejections applicant argues that the independent claim 1 has been amended to incorporate subject matter previously indicated as free of the prior art. This argument is not persuasive because claim 1 contains additional amendments (i.e. lines 8-12 of the claim) which have changed the scope of the claim from what was previously indicated to be free of the prior art. The previous 102 and 103 rejections are withdrawn in favor of the new grounds of rejection provided above which address the amended claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677