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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
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 11 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. The limitations of claim 11 are already recited in claim 1. 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.
Claim(s) 1, 3, 8, 9, 11, 14-16, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009029859 (hereinafter “Hao”).
Applicant’s claim 1 recites:
“A carrier system for an assay comprising
a carrier in which a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres,
wherein the carrier is secured to a substrate by a release layer,
the carrier system being adapted to receive the assay sample onto the carrier while the carrier is in contact with the substrate,
and the release layer being configured in use to release the carrier from the substrate in the presence of a biocompatible aqueous solution.”
Regarding these limitations, Hao discloses the following.
DNA nanoarrays [are used for] on-site and point-of-care applications, and optical detection. Para. 0005.
One alternative to fluorescence-label based DNA microarrays are magnetic-label based DNA microarray, also known as magnetic DNA microarray. Magnetic DNA microarray is based on the detection of biologically functionalized magnetic labels using magnetoresistive magnetic field sensors. This magnetic detection scheme will provide a practical detection method for DNA nanoarrays, realizing nanoarrays as a next generation of DNA microarrays. Para. 0006.
Commercially available magnetic labels for magnetic DNA microarrays are beads of dispersed iron oxide particles in a polymer. The iron oxide beads typically have a 10-20% of iron oxide in each particle and are required to be in the range of several micrometers to produce enough magnetic fields to be detected. Alternative particles commercially available which may be smaller, often suffer from reduced magnetic moments and broad size distribution. A reduced moment may result in non-detection of the particle and a broad size distribution may result in improperly labeling and subsequent detection. Additionally, magnetic particles for use in magnetic DNA microarrays have been observed to have a lack of size uniformity and the particles tend to aggregate due to magnetic attraction, which may result in embedding a undesirable amount magnetic particles or result in a large size distribution of the labels to provide imprecise readings. Para. 0007.
Provided herein are systems, methods and compositions for forming structures having desired inter-structure and intra-structure magnetic moments. Included are magnetic DNAmicroarrays that have a uniform size distribution, a lack of aggregation, and sufficient moment to be detected by a magnetic scanner. Para. 0008.
“In another embodiment of the nanodisk 100 as shown in FIG. ID, the structure comprises a nanodisk 100 having a stack of interlayers including the first non-magnetic layer 110, the first magnetic layer 120 disposed on first non-magnetic layer 110, a second nonmagnetic layer 130 disposed on the first magnetic layer 120, the second magnetic layer 140 disposed on the first non-magnetic layer 130, and a third non-magnetic layer 150 disposed on the second magnetic layer 140. Optionally, the nanodisk 100 may further comprise a sacrificial layer 105 on which the first non-magnetic layer 110 may be disposed. The first and second magnetic layers 120 and 140, the first, second, and third nonmagnetic layers 110, 130, and 140, and the sacrificial layer 105 include a disk-like shape, comprising a first circular face, a second circular face, a diameter D for the disk, and a thickness T between the first and second circular face. The nanodisk 100 may have a diameter or width between about 1 nanometer and about 200 nanometers, such as between about 20 nanometers and about 100 nanometers, for example, about 65 nanometers. The nanodisk 100 may have a shape selected from the group of disk-like, circular, annular, round, elliptical, hexagonal, octagonal or similar shape, and combinations thereof as well as any shaped formed in the template/substrate on which it is formed. The first and second magnetic layers 120 and 140, the first, second, and third nonmagnetic layers 110, 130, and 140 may be facially coupled with each respective layer, such that there are no gaps between interlayers. FIG. IE is plane view SEM micrograph of one embodiment of the nanodisks. FIG. IF is a graph of the hysteresis loop of a bulk multilayer nanodisks with the film on flat substrate and the field of plane.” Para. 0028 (emphasis added).
“Optionally, the nanodisk may further comprise a sacrificial layer 105 on which the first non-magnetic layer 110 may be disposed, as shown in FIG. ID. The sacrificial layer 105 provides a base structure on which the nanodisk layer may be deposited. The sacrificial layer 105 is disposed on a template and the shape, such as a disk-like, round, elliptical, hexagonal, octagonal or similar shape, of the sacrificial layer reflects the shape of the template on which it is disposed. The sacrificial layer 105 may comprise a salt, such as Group I or II metal salt selected from the group of sodium chloride, potassium chloride, or combinations thereof. Alternatively, the sacrificial layer 105 may comprise a metal, such as one selected from the group of copper, silver, aluminum, and combinations thereof, and may be dissolved in an aqueous solution of metal etchants. Preferably, the sacrificial layer 105 is a salt that may be dissolved in water. The sacrificial layer may be deposited to a thickness between about 20 nanometers and about 200 nanometers.” Para. 0032 (emphasis added).
“FIG. 2A is a perspective schematic view of one embodiment of the nanodisk 100 formation process. The nanodisk 100 may be formed in one embodiment by a support post membrane or a template growth method. In the support post membrane or the template method, a membrane or template 160 having support posts or pillars 185 formed therein, as shown in Step 250 of FIG. 2A, is provided to a deposition apparatus. The deposition apparatus may include an electrodeposition cell, chemical vapor deposition (CVD) apparatus, and the like. The template 160 may serve as a working electrode with a metal film in the electrodeposition cell. The nanodisk 100 material layers including the sacrificial layer are then deposited on the support posts 185 and the membrane or template 160, as shown in Step 260 of FIG. 2 A. Alternatively, and not shown, the nanodisk 100 material layers may be selectively deposited on the support posts 185 without any of the nanodisk materials 100 being deposited on the membrane or template 160 surface. The template 160 may then be exposed to a solution dissolving the nanodisks 100 from the template 160 as shown in Step 270. The support posts 185 of the template 160 can be resusable after cleaning the deposited materials on the substrate bottom.” Para. 0044 (emphasis added).
“FIGS. 2B-2I are schematic perspective views further detailing one embodiment of the nanodisk layering process 200. A template 160 is provided for the formation of the nanodisk 100 thereon in step 210 as shown in FIG. 2B. The template 160 may comprise any suitable material such as an anodic aluminum oxide, and may also comprise a membrane material, such as titanium oxide (TiO2 ). The template 160 includes a first side 167, a second side 169, and a plurality of apertures 162 formed in the template from the first side 167 to the second side 169 as shown in FIG. 2B. The template 160 may be between about 100 nanometers and about 60,000 nanometers thick. Alternatively, some of the apertures 162 may not be formed completely from the first side 167 to the second side 169. A template structure for depositing the nanodisk materials thereon may also be manufactured from patterning processes including anodic alumina, nanosphere lithography, interference lithography, block copolymer lithography, and imprint lithography in addition to the process described herein.” Para. 0045 (emphasis added).
Thus Hao discloses a carrier [i.e., the Hao nanodisk] secured to a substrate [i.e., the Hao template/substrate] by a release layer [i.e., the Hao sacrificial layer] (see paras. 0028 and 0044).
Examiner notes that the present claims under examination are directed to a system (or device), as opposed to a method, and therefore a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Thus, while the disclosures of Hao as mentioned above relates to the formation of the nanodisk, rather than performing an assay, nevertheless, the Hao disclosures meet the claimed limitations as follows.
The recitation in claim 1 regarding “the carrier system being adapted to receive the assay sample onto the carrier while the carrier is in contact with the substrate, and the release layer being configured in use to release the carrier from the substrate in the presence of a biocompatible aqueous solution” relates to intended use, and therefore the prior art meets the claim if the prior art structure is capable of performing the intended use.
Examiner notes that the Hao nanodisk (equivalent to Applicant’s claimed carrier) that is secured to the Hao sacrificial layer (equivalent to Applicant’s claimed substrate) is capable of receiving an assay sample onto the nanodisk (the claimed carrier) while the nanodisk (carrier) is in contact with the sacrificial layer (substrate), and thus meeting Applicant’s claim 1.
Also, the Hao sacrificial layer (equivalent to Applicant’s release layer) is capable of releasing (and therefore is considered configured in use to release) the carrier from the substrate in the presence of a biocompatible aqueous solution, thus meeting Applicant’s claim 1.
As to the limitation that recites “a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres”, Examiner notes that Hao discloses that beads are typically in the range of several micrometers (para. 0007). Moreover, the claimed dimension is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Hao. Discovery of the dimension merely requires changing known parameter(s) disclosed by Hao to discover a workable or optimum range.
Applicant’s claim 3 recites the carrier system according to claim 1 “in which the assay sample is suspended in the biocompatible aqueous solution,
and in which when the carrier system is contacted with the biocompatible solution,
the assay sample is received onto the carrier and the carrier is released from the substrate.”
Examiner finds that the carrier system of Hao (discussed above regarding claim 1) is capable of performing these intended use, including having the carrier be released from the substrate [see discussion above regarding claim 1 and the release of the nanodisk by dissolving the sacrificial layer].
Applicant’s claim 8 recites the carrier system according to claim 1, “wherein the carrier comprises a magnetic material.” See Hao’s magnetic layer in the nanodisk (para. 0028 and 0032).
Applicant’s claim 9 recite “a carrier system according to claim 8,
wherein the carrier comprises a layered structure between a top surface of the carrier and an opposed bottom surface of the carrier,
the layers including one or more magnetized layers
in which the ratio of a lateral dimension of the one or more magnetized layers to a thickness or aggregate thickness of the magnetized layer or layers is greater than 500.”
Hao teach that the carrier [nanodisk] comprises a layered structure between a top surface of the carrier and an opposed bottom surface of the carrier [see Hao in para. 0028],
the layers including one or more magnetized layers [see Hao in para. 0028].
Hao is silent as to the limitations reciting that the ratio of a lateral dimension of the one or more magnetized layers to a thickness or aggregate thickness of the magnetized layer or layers is greater than 500.
However, discovery of a workable or optimum range requires ordinary skills in the art where the general conditions of the claim are disclosed by the prior art. The recited ratio is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Hao. Discovery of the ratio merely requires changing known parameter(s) disclosed by Hao, to discover a workable or optimum range.
Applicant’s claim 11 recites a “carrier system according to claim 1, in which a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres.”
The recited dimension is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Hao. Discovery of the dimension merely requires changing known parameter(s) disclosed by Hao, to discover a workable or optimum range.
Applicant’s claim 14 recites a “carrier system according to claim 1,
wherein a surface of the carrier is adapted for receiving the assay sample.”
Hao meets this limitation since the surface of the carrier [nanodisk] is capable of receiving an assay sample.
Applicant’s claim 15 recites a “carrier system according to claim 1,
wherein the carrier comprises a readable code.”
Hao teaches these limitations as follows.
“Once the nanodisks 100 are disposed on the respective DNA strands to form a detectable structure 450, one or more magnetic sensors 460, such a maganetoresistive sensor is scanned across the DNA arrays 400 to detect magnetic fields. The detected magnetic fields of the magnetic-nanodisk labeled microarray surface are then converted into an electronic signal and forwarded to a process for assembling the data for analysis. Examples of suitable sensors are a read head inside the computer hard disk, a magnetic tunneling junction sensor, and combinations thereof. The computer hard disk includes a magnetoresistive sensor to detect extremely small magnetic objects is already convincingly demonstrated in every personal computer. Suitable scanners include those with scanner read heads, sensors, which are utilized in computer hard disks. Other suitable sensors include magnetic tunnel junction sensors (MTJ) which include two magnetic layers separated by an insulating spacer layer.” Para. 0072.
Examiner notes that electrical signal, representing the magnetic field, is equivalent to a readable code. Alternatively, any aspect of the nanodisk structure is equivalent to a readable code.
Applicant’s claim 16 recites a “carrier system according to claim 1, comprising a plurality of carriers, wherein each of the carriers is secured to the substrate by the release layer.” See Hao’s disclosure in paragraph 0044 disclose nanodisks.
Applicant’s claim 37 recites a “carrier system according to claim 1, in which the assay sample comprises a cell.”
Examiner notes that Hao meets this limitation since the Hao nanodisk system is capable of receiving an assay sample that comprises a cell.
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009029859 (hereinafter “Hao”) in view of US 20030153059 (hereinafter “Pilkington”).
Applicant’s claim 17 recites a “carrier system according to claim 1, comprising sterile packaging from which the carrier secured to the substrate is removable for use.”
While Hao is silent as to this limitation, such limitation would have been obvious to one skilled in the art given that it results in a predictable outcome of providing a sterile carrier for use in an assay, as would be desirable for avoiding contamination or potentially less accurate assay results.
Moreover, Pilkington teaches the following, which would have suggested to one skilled in the art to provide a sterile packaging.
“Since the immobilized cell beads are produced outside the bioreactor, aseptic techniques must be utilized throughout the bead formation process and sterility maintained until the beads are introduced into the bioreactor. The various transfer points between tanks provide opportunity for contamination and must be monitored due to the fact that the presence of a contaminant could result in its co-immobilization within the bead. As a result of diligence within the laboratory, it was possible to consistently produce aseptic beads. However, the environment within a plant setting may not be as hospitable as the laboratory, therefore requiring much stricter control.” Para. 0554 (emphasis added).
Thus, one skilled in the art would have been suggested by Pilkington to provide in the Hao invention a sterile carrier for use in an assay, as would be desirable for avoiding contamination or potentially less accurate assay results.
Claim(s) 1, 3, 7, 11, 14-17, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20110022026 (hereinafter “Sorensen”).
Applicant’s claim 1 recites:
“A carrier system for an assay comprising
a carrier in which a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres,
wherein the carrier is secured to a substrate by a release layer,
the carrier system being adapted to receive the assay sample onto the carrier while the carrier is in contact with the substrate,
and the release layer being configured in use to release the carrier from the substrate in the presence of a biocompatible aqueous solution.”
Sorensen meets these limitations by teaching the following.
“The present invention relates to a method of delivering drug(s), agent(s), cells or biological substances (the term "agent" includes drugs, biological substances, and biologics as those terms are used in their arts) in a target-specific manner, through the use of a drug or therapy-coated guidewire segment, portion or member, which includes drug delivery means and guidewire structure. The claimed method provides a therapy that targets the traumatized area by proximity alone or in combination with a systemic effect i.e. delivery from an exterior surface of a guidewire. A drug of the present invention provides, for example, anti-proliferative therapeutic activity to the cardiovascular system. A drug of this invention generally is effective locally, i.e., at the site of vessel contact, but may have more general systemic effects. A drug deployed by means of the present invention does not require a delayed or long term release and can be used, e.g., to activate anti-proliferative activity immediately upon contact with the cells of the target tissue or circulation. The drug may have sustained anti-proliferative activity and thus, a prolonged effect. The drug is preferably released in less than about or equal to one minute from the time of its initial contact with the tissue or circulation although longer drug release time will often be used depending upon the drug, the specific therapy and related indications and side effects. FIGS. 4 and 5 shown in section an embodiment of this invention in which a monofilament expansion member is used.” Para. 0030 (emphasis added).
“The drugs or agents coated upon the guidewire surface, e.g., a radially-expanding surface, and thus useful in the present invention are delivered to the target tissue in a short time after the device's initial contact with the targeted tissue or surrounding circulation, i.e., there is a relatively quick release of the drug from the guidewire to the tissue. The drugs which can be used in the present invention provide, in one approach, anti-proliferative activity in the cardiovascular system. Other agents may promote tissue growth to expedite vessel healing, e.g. anti-h-CO54 antibody.” Para. 0031 (emphasis added).
“In one embodiment, the activity of the drug may be sustained and the drug exhibits a prolonged anti-proliferative effect. Therefore, the drug does not require a delayed or prolonged release and as such, the release can be immediate. Accordingly, the drug may be attached to a working or delivery surface of the device that is not a permanent implant but rather briefly contacts the tissue or circulation. Additionally, due to its sustained effect, the drug may also be encapsulated in a particle which may enhance its uptake by the target tissue or cells.” Para. 0032 (emphasis added).
“The drugs may be directly applied to the guidewire expansion member in a composite, wherein the drugs are mixed with other reagents, or may be encapsulated within drug release particles such as liposomes, microparticles, nanoparticles, or aggregates of the drug. The particles may include inert polymeric particles, such as, for example, microparticles or nanoparticles. Alternatively, the particles may comprise biologically derived reagents, such as, for example, lipids, sugars, carbohydrates, proteins and the like. Specifically, such particles are release carriers which provide an effective release of the therapeutic agent to the target tissue or cells. The therapeutic agent formulation may be specifically taken up by cells of the white blood-cell lineage, such as macrophages or monocytes. By this means, the drugs are delivered in a target-specific manner, without the need to provide a full dosage of drugs to the entire body through conventional drug delivery routes as discussed above. Indeed, providing the therapeutic agent in a localized manner or to specific cells can avoid the undesired side effects of such large doses. The drug release carriers are preferably biodegradable, so that when they are brought into contact with the target tissue or circulation or when taken into specific cells, the drug or therapeutic agent is quickly released from the carrier, and then the biodegradable carrier is itself, in due time, removed by natural body processes.” Para. 0033 (emphasis added).
“In one embodiment of the present invention the particles or release carriers include, but are not limited to, semi-synthetic polyacryl starch microparticles, other biodegradable microparticles containing the therapeutic agent, ethyl cellulose, poly-L-lactic acid, heptakis (2,6-di-O-ethyl)-beta-cyclodextrin, polyalkylcyanoacrylate nano capsules, polymethylacrylate, monocarboxycellulose, alginic acid, hyaluronic acid, lipid bilayer beads, polyvinylpyrollidone, polyvinyl alcohol, albumin, lipid carriers of continuous phase (non-microparticle type), nanoparticles, and known agents by those skilled in the art for the release of therapeutic agents. Nanoparticles are preferably spherical or non-spherical polymeric particles that are 30-500 nm in diameter.” Para. 0034 (emphasis added).
“In a further embodiment of the present invention, the therapeutic agent or drug may be encapsulated within, or form itself, a liposome, colloid, aggregate, particle, flocculate or other such structure known in the art for encapsulation of drugs. The encapsulation material itself may have a known and predetermined rate of biodegradation or bioerosion, such that the rate of release and amount released is a function of the rate of biodegradation or bioerosion of the encapsulation material. Preferably, the encapsulation material should provide a relatively quick release rate.” Para. 0035 (emphasis added).
“In yet a further embodiment of the present invention, the particles, or release carriers, may be supported within the matrix of a macrostructure. Particles or controlled release carriers, as previously discussed, include, but are not limited to microparticles, nanoparticles, colloids, aggregates, liposomes, particles, or flocculates. Materials used to provide the macrostructure include, but are not limited to, fibrin gels, hydrogels, or glucose. Non-limiting examples of particles supported within a macrostructure include a fibrin gel with colloid suspended within it; a hydrogel with liposomes suspended within it; a polymeric macrostructure with macroaggregated albumin suspended within it; glucose with liposomes suspended within it; or any of the foregoing further including liposomes, flocculants microparticles, nanoparticles, or other particles containing or having dispersed therein a drug or therapeutic agent. In the use of this invention it need not be that the macrostructures nor the particles be entirely bioabsorbed. For example if fibrin or collagen is used to provide the macrostructure, such materials are biodegradable yet can persist in the extracellular matrix for substantial lengths of time.” Para. 0036 (emphasis added).
“The therapeutic agent, preferably encapsulated in a particle or a controlled release carrier, or aggregated to a desirable/pre-selected size, for efficient uptake by a macrophage, is applied to the surface of the guidewire by coating methods known in the art, including, but not limited to spraying, dipping, rolling, brushing, solvent bonding, adhesives or welding or by binding the microparticle or aggregates to the surface of the guidewire by any chemical method known in the art. Furthermore, if the guidewire has folds, corrugations, cusps, pores, apertures, or the like, the therapeutic agent or particle encapsulating the therapeutic agent may be embedded, i.e., mechanically trapped, within the guidewire without the use of adhesives. In addition to the drug coated on the guidewire, an additional dosage of the therapeutic drug, which inhibits proliferation in the cardiovascular system, may be applied by conventional delivery methods discussed above, (e.g., orally, intravenously) or may be injected through the guidewire. For example, the therapeutic drug may be injected through the guiding catheter via the same method and procedure used to inject the contrast dye commonly used during a PTA. The particles are preferably selected from the group consisting of lipids, microparticles, nanoparticles, or the drug itself in aggregates, flocculates or the like.” Para. 0062 (emphasis added).
Regarding Applicant’s claims, Examiner notes that the present claims under examination are directed to a system (or device), as opposed to a method, and therefore a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Thus, while the disclosures of Sorensen as mentioned above relates to the release of a drug to a patient, rather than performing an assay, nevertheless, the Sorensen disclosures meet the claimed limitations as follows.
As to Applicant’s claim 1, Sorensen discloses a drug that may be in a particle that comprises or is encapsulated by a sugar (para. 0033) or polyvinal alcohol (para. 0034) or glucose (para. 0036) that is coated on a guidewire for release of the drug (paras. 0030-33 and 0035-0036).
Examiner notes that it is understood that the sugar or polyvinal alcohol or glucose releases the drug from the guidewire.
Examiner notes that the Sorensen invention is capable of receiving the assay sample onto the carrier while the carrier [i.e., the Sorensen drug and/or particle] is in contact with the substrate [i.e., the Sorensen guidewire].
Regarding the limitation that recites the “carrier system according to claim 1, in which a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres.”
The recited dimension is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Sorensen. Discovery of the dimension merely requires changing known parameter(s) disclosed by Sorensen, to discover a workable or optimum range.
Applicant’s claim 3 recites the carrier system according to claim 1 “in which the assay sample is suspended in the biocompatible aqueous solution,
and in which when the carrier system is contacted with the biocompatible solution,
the assay sample is received onto the carrier and the carrier is released from the substrate.”
Examiner finds that the carrier system of Sorensen (discussed above regarding claim 1) is capable of performing these intended use, including having the carrier [i.e., drug and/or particle] within the sugar (or glucose or polyvinal alcohol) be released from the substrate [i.e., the guidewire [see discussion above regarding claim 1].
Applicant 7 recites the carrier system of claim 1, “wherein the release layer comprises at least one of a sugar.” Sorensen discloses a drug that may be in a particle that comprises or is encapsulated by a sugar (para. 0033) or polyvinal alcohol (para. 0034) or glucose (para. 0036) that is coated on a guidewire for release of the drug (paras. 0030-33 and 0035-0036). Examiner notes that it is understood that the sugar or polyvinal alcohol or glucose releases the drug from the guidewire.
Applicant’s claim 11 recites a “carrier system according to claim 1, in which a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres.”
The recited dimension is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Sorensen. Discovery of the dimension merely requires changing known parameter(s) disclosed by Sorensen, to discover a workable or optimum range.
Applicant’s claim 14 recites a “carrier system according to claim 1,
wherein a surface of the carrier is adapted for receiving the assay sample.”
Sorenson meets this limitation since the drug coated guidewire is capable of receiving an assay sample.
Applicant’s claim 15 recites a “carrier system according to claim 1,
wherein the carrier comprises readable code”.
The Sorensen drug and guidewire is considered to meet this limitation under the broadest reasonable interpretation since Applicant has not limited the “readable code” such that it avoids any kind of reading of information on the device.
Applicant’s claim 16 recites a “carrier system according to claim 1, comprising a plurality of carriers, wherein each of the carriers is secured to the substrate by the release layer.” See discussion above regarding claim 1 and Sorensen.
Applicant’s claim 17 recites a “carrier system according to claim 1, comprising sterile packaging from which the carrier secured to the substrate is removable for use.”
While Sorensen is silent as to this limitation, such limitation would have been obvious to one skilled in the art given that it results in a predictable outcome of providing a sterile environment for avoiding contamination, as would be desirable in providing a therapeutic agent.
Applicant’s claim 37 recites a “carrier system according to claim 1, in which the assay sample comprises a cell.”
Examiner notes that Sorensen meets this limitation since the Sorensen invention is capable of receiving an assay sample that comprises a cell.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant states that Hao discloses small magnetic “nanodisks” for DNA microarrays or for detecting of other molecules or cells. Applicant argues that the nanodisks in Hao are much smaller than 5 micrometres, as they are described as ranging from about 10 to about 200 nm in size (page 5, lines 9-10).
Applicant also argues on page 12 of the response that Hao teaches that it is desirable to keep the microarray as small as possible and that disks of 10-200 nm are large enough to perform the desired function of acting as magnetic labels.
This is not persuasive since the embodiment disclosed on page 5 is a non-limiting embodiment as an example.
As noted in the grounds for rejection above, Hao discloses that beads are typically in the range of several micrometers (para. 0007). Moreover, the claimed dimension is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Hao. Discovery of the dimension merely requires changing known parameter(s) disclosed by Hao to discover a workable or optimum range.
Applicant also argues that Hao fails to disclose a carrier system that is adapted to receive an assay sample onto the carrier while the carrier is in contact with the substrate. The nanodisks of Hao are configured to act as magnetic labels in DNA microarrays. Hao discloses manufacturing the nanodisks. Hao also discloses “free nanodisks 190 in solution as shown in FIG 2H may then be used in processing with the microarray”.
This is not persuasive, as the claim is directed to a device, as opposed to a method. Therefore the recitation in claim 1 regarding “the carrier system being adapted to receive the assay sample onto the carrier while the carrier is in contact with the substrate, and the release layer being configured in use to release the carrier from the substrate in the presence of a biocompatible aqueous solution” relates to intended use, and as such the prior art meets the claim if the prior art structure is capable of performing the intended use.
Examiner notes that the Hao nanodisk (equivalent to Applicant’s claimed carrier) that is secured to the Hao sacrificial layer (equivalent to Applicant’s claimed substrate) is capable of receiving an assay sample onto the nanodisk (the claimed carrier) while the nanodisk (carrier) is in contact with the sacrificial layer (substrate), and thus meeting Applicant’s claim 1.
Regarding Sorensen, Applicant argues that the specific example of particle dimensions taught by Sorensen are nanoparticles that are “30-500 nm in diameter) (para. 0034).
However, Examiner notes that Sorensen discloses in paragraph 0034 “microparticles” as well as “nanoparticles, as well as elsewhere throughout the patent. Moreover, the disclosure of 30-500 nm in diameter is a non-limiting example in paragraph 0034.
Applicant also argues that there is no reason that the skilled person would consider implementing particles having “ a minimum lateral dimension of the carrier is between 5 micrometres and 200 micrometres”. There is no teaching or suggestion in the prior art that the size of the particles of Sorensen should be modified.
Applicant further argues that the particles of Sorensen are not carriers for receiving an assay sample. The particles of Sorensen are encapsulated drugs that are released from the guidewire member to target tissue or cells. The drugs are not a “carrier” and the system of Sorensen is not adapted to receive an assay sample onto the drug.
These arguments are not persuasive as Applicant’s claims are directed to a device, rather than a method, and thus the prior art meets the claims if the prior art device is capable of performing the intended use. Moreover, regarding dimensions, the recited dimension is within a workable or optimum range, and its discovery requires ordinary skills in the art given that the general conditions of the claim is disclosed by Sorensen. Discovery of the dimension merely requires changing known parameter(s) disclosed by Sorensen, to discover a workable or optimum range.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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