DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains legal phraseology, such as “comprising”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: In paragraph [0073], reference numeral (100) refers to both a composition and a bead that is also reference by (110) in paragraph [0074].
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There is no method of composing a composition defined by the steps as provided for in claims 22-23 described in the specification. Furthermore, there is no description as provided for in claims 31, 36 and 39 in the specification. See the specification and original claims 31, 36 and 39. It is noted that the “composition” as not claimed is not a metalized bead.
Appropriate correction is required. It is hereby requested that applicant provide for the specific text that supports each and all amendments.
Claim Objections
Claim 5 is objected to because of the following informalities: the claim is missing a (.) period at the end of the claim . Appropriate correction is required.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the composition claims mention a target molecule of a biological sample. However, it is noted that the biological sample and target molecule of such sample are not positively claimed as elements of the composition (do not define the composition). The biological sample and target molecule are considered as materials and/or articles intended to be, can be worked upon, used with the composition. In claim 1, the composition is not required to be used in any process including with any unclaimed biological sample.
It is noted that the various “configured to…” clauses recited throughout the claims do not provide for any further structure. For example, in claim 3 the phrase is directed to possible use of the metal particle.
It is noted that the term “or” is directed to alternatives, not requirements.
It is noted that the phrase “at least one” only requires “one”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-7, 14-16, 20-24, 29-33, 36, and 39 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.
As to claim 1, it is unclear how a bead, a probe, and a metal particle can be considered as a “composition” because the separate components do not define a single material such as a bead, nor any other single material nor mixture of components such as a solution. The claim is not consistent with the specification nor Figure 6 where it appears that the composition comprises is a buffer liquid (100) that contains a bead (110) having a surface, a molecule of interest (120) configured to…on the surface of the bead; a probe molecule; and a metal particle (150). Therefore, the claim is not consistent with the specification.
Claim 1 recites the limitation "its surface” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is presumed that that the phrase is intended to refer to bead. Therefore, it appears as if the claim should read as “a bead having a surface and on the surface a molecule of interest….” or something similar.
Dependent claims 2, 4-7, 14-16, 20-24, 29-33, 36, and 39 are rejected via dependency upon a rejected claim.
Claims 2 and 36 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “wherein the identifying characteristic is selected from a group consisting of “an electrical impedance signature, optical barcoding, shape, size, porosity, conductivity, permittivity, permeability, and stiffness” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The alternatives are not all members of the same recognized physical or chemical class or the same art-recognized class; and the members are not considered to be functionally equivalent. For example, optical barcoding is not structurally physically the same as other members of the of the alternatives. The same is applicable to other members of the alternatives.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Furthermore, it is unclear what is the difference between “a spherical shape” and “shape” recited in the last paragraph because a spherical shape is a shape.
It is unclear what is further structurally required by claim 7 because the claim does not provide for any further structure of the bead, what the bead comprises. Instead, the claim recites what was is intended be used to functionalize the bead. Such “chemistry” is not an element of the bead.
It is unclear what is further structurally required by claims 14-16, and portions of claim 20 directed to the target molecule of interest and the biological sample because neither of such are positively claimed as elements of the composition nor any prior positively claimed element. See Claim Interpretations
As to claim 20, it is unclear what is the nexus of the phosphate buffer to the prior positively claimed elements (bead, probe molecule, and metal particle) because the claim does provide for such.
Furthermore, it is unclear what is meant, required by the phrase “the probe molecule at least one of horseradish peroxidase or alkaline phosphatase” because the phrase appears to be grammatically incorrect.
As to claim 23, it is unclear what is further required to be done by who/what to perform modifying the electrical property because the claim nor specification provides for such. The claim does not appear to be consistent with the specification nor original claims because there is no such modifying step discloses that is distinct from binding the metal particle to the bead. The metal particle being bound to the bead is the same as the modifying. See for example, the original claim and specification (paragraphs 0023 and 87 of the publication).
The term “approximately” in claims 24 and 32-33 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the specification states: “Ranges may be expressed herein as from “about” or “approximately” or “substantially” one particular value and/or to “about” or “approximately” or “substantially” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value.” The term is not defined so as to determine what specific values other than the recited exact values in the claims are considered as being “approximately” the recited specified values.
As to claim 29-30 and 39, it is unclear what is structurally required to define a “sensing zone” because such is not defined in the claim by any specific structure, nor structural dimensions, boundaries so as to determine what is such sensing zone. Furthermore, it is noted that an inlet and outlet are not defined as being any specific structure. The terms “inlet” and “outlet” are moreso directed to intended use. Something that is labeled as inlet is not precluded from being used as an outlet and vice versa. However, it is noted that the claim does not required the inlet and outlet to be used to do anything in the method. The sensing zone, inlet, and outlet are not required to be structurally connected. Any space, location “between” a broad “inlet” and “outlet” can be considered as a “sensing zone”.
Therefore, it is also unclear what is structurally required for each to have a recited shape as recited in claim 30. A pyramid is a three-dimensional geometric shape with a flat polygonal base and triangular faces that converge at a single point called the apex. However the inlet and outlet are defined as being any specific structural. Therefore, it is unclear what is structurally required of such to have “pyramidal shape as recited in the claim.
Furthermore, a square is a two-dimensional shape. As noted above the sensing zone, has not been defined as being any structure, therefore, it is unclear what required of such to have a square shape. If such zone, is intended to be an actual structure, it presumed that such structure would be 3+ dimensional. Therefore, such zone would not simply have a two-dimensional square shape. It appear that the square shape would be applicable to a specific cross-sectional shape. However, the claim does not provide for such.
The term “proximate” in claim 39 is a relative term which renders the claim indefinite. The term “proximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “proximate” does not provide for any structurally connection, definitive distance, nor definitive relative location of any structures. Any structures regardless of relative location and distance can subjectively be considered as “proximate” to each other. However, what may be considered as proximate to one person may not be considered as such to another and vice versa.
It is noted that the term “aperture” is known to mean an opening or hole. An opening and hole (aperture) are known to what can be labeled as an inlet and/or outlet, not than such an opening or hole comprises and inlet an outlet. It is unclear what is structurally required to define an “inlet” and “outlet” of an aperture and a sensing zone because the claim does not provide for such. See also prior rejection above. Furthermore, it is noted that the electrical property sensor is not defined by any specific structure.
It is unclear what is the structurally connectivity of the inlet, outlet, and sensing zone because the phrase “disposed between” does not require nor provide for any structural connectivity such that the structures define a single “aperture”.
Furthermore, it is unclear what is structural required by the “configure to..” clause because such does not provide for any further structure of the “aperture”. The aperture (hole, opening) is not capable of nor claimed as comprising any structure capable of providing any motive force to the composition.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-7, and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawde et al., “Amplified Electrical Transduction of DNA Hybridization Based on Polymeric Beads Loaded with Multiple Gold Nanoparticle Tags” (cited by applicant).
As to claim 1, Kawde discloses a composition (abstract, particle-based, i.e., a composition, electrical DNA detection) comprising: a bead having on its surface a molecule of interest configured to bind with a target molecule in a biological sample (abstract, particle-based electrical DNA detection based on oligonucleotides functionalized with polymeric beads carrying numerous gold nanoparticle tags; page 103, column 1, second paragraph, the albumin-biotin labeled 5-nm colloidal gold (containing 1x101111 particles) was added into a vial containing 21 µL TTL; mixing proceeded gently for 15 mm at room temperature to load the gold nanoparticles onto the polystyrene beads); a probe molecule configured to bind with the target molecule (abstract, particle-based electrical DNA detection; page 103, column 1, second paragraph, the target-labeled gold-loaded polystyrene microspheres, in each of the 0.5 µL vials, were suspended into 50 µL hybridization (TTL) buffer, and transferred completely to a 1.5 ml vial containing the probe-functionalized magnetic beads, the hybridization proceeded at room temperature with gentle mixing for 20 min. The resulting DNA-linked particle assembly); and a metal particle configured to bind with the probe molecule (page 102, figure 1; page 103, column 1, second paragraph, the target-labeled gold-loaded polystyrene microspheres ... containing the probe-functionalized magnetic beads ... the resulting DNA-linked particle assembly).
As to claim 2, Kawde discloses the composition of claim 1, wherein the bead (spherical) further comprises an identifying characteristic (abstract, particle-based electrical DNA detection ... amplified electrical transduction allows detection of DNA targets down to the 300amol level, and offers great promise for ultrasensitive detection of other biorecogntion events; page 106, column 1, first paragraph, the amplified electrical signal).
As to claim 4, Kawde discloses wherein the metal particle is configured to modify an electrical property of the bead (page 107, column 1, second paragraph, use of carrier-sphere amplifiers has been combined with catalytic enlargement of the multiple gold-particle tags and the preconcentration feature of the electrochemical stripping detection to yield a dramatic enhancement of the sensitivity).
As to claim 5, Kawde discloses wherein the metal particle comprises a silver nanoparticle, a gold nanoparticle (abstract, particle-based electrical DNA detection based on oligonucleotides functionalized with polymeric beads carrying numerous gold nanoparticle tags), and an iron nanoparticle nanoparticle.
As to claim 6, the beads comprise polystyrene (see remarks directed to claim 1; page 105, left column, line 4).
As to claims 7 and 16, the claims do not provide for any further element of the composition. See Claim Interpretations.
As to claims 14-15, the bead includes DNA. See remarks above directed to claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-22, 29-32, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawde et al. as applied above, and further in view of Takulapalli; Bharath, US 10,514,380.
Kawde does not a method comprising moving the composition of claim 1 past an electrical measuring device; and measuring an electrical property of the composition.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Takulapalli discloses device that can be used to sense and characterize a variety of materials. The device may be used for a variety of applications, including genome sequencing, protein sequencing, biomolecular sequencing, and detection of ions, molecules, chemicals, biomolecules, metal atoms, polymers, nanoparticles (beads) and the like. For example, the device can be used for detecting un-modified proteins, DNA and other biomolecules or proteins, DNA, biomolecules that have been modified with chemical tags or metal atom tags, nanoparticle tags, hybridization markers, or the like. (paragraph 0007).
The device can be employed for detecting a variation in an electrical property of the device as the material passes through the nanopore. The material may be organic material, a nanoparticle, ionic species, molecular species, such as material selected from the group consisting of a DNA molecule, a protein molecule, a peptide molecule, a polypeptide molecule, an RNA molecule, a synthetic oligo nucleotide molecule, and a synthetic peptide or polypeptide molecule. The material to be sensed may be modified with at least one tag selected from the group consisting of metal species, metal-organic species, chemical modifiers, biomolecular tags, complementary hybridizing chain molecules, peptides, polypeptides, oligonucleotides, zinc fingers, nano particles, quantum dots, organic dyes, beads, nanowires, nanotubes. (paragraph 0013).
It would have been obvious to and within the common sense, knowledge and skill of one ordinary skill in the art to recognize that a measuring device may employed to analyze a material including the claimed composition to measure an electrical property of the composition as taught by Takulapalli.
As to claim 22, Kawde discloses the steps as claimed. See prior rejection above.
As to claims 29-32, and 39, Takulapalli teaches that the a suspension including the composition is passed through a device including an aperture including an inlet and an outlet; a “sensing zone” between such inlet and outlet and a sensing device to allow for the measuring of an electrical property of the composition. The inlet and outlet are “pyramidal shaped” and the sensing zone is square-shaped. (See figures, including Figure 6 and description of the Figures).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Guttman; Mitchell et al.
CHOU; Stephen Y. et al.; Draz; Mohamed Shehata et al.; CHEN; Hui et al.; Koh; Chung-Yan et al.; TOKUDA; Takahiko et al.; Fan; Christina et al.; Chung; Taek Dong et al.; TSAO; Dean et al.; Henzler; Tanja et al.; Svendsen; Winnie et al.; Davis; Ronald W. et al.; Huang; Xiaohua et al.; Moon, John et al.; Huang, Mingxian et al.; Siiman; Olavi et al.; and Graves; David J. et al. disclose beads.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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