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 .
Claim Objections
Thank you for kindly correcting this matter.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: The drawings do not contain reference numbers in any of the figures. Please kindly correct. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16, 19, 20 and 22-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within one of the four categories of patent eligible subject matter, but rather it is unclear which category is intended because the preamble of claim 1 and all dependent claims contain “a product of manufacture, a device, an apparatus, or a system for testing.” Claim 1 also requires software which is incongruent with a device, product of manufacture or apparatus. Part (c) also includes an imaging system which is incongruent with device, product of manufacture, and apparatus.
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 1-16, 19, 20 and 22-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the imaging system" in page 5 of the claims. There is insufficient antecedent basis for this limitation in the claim.
Claim 1, it is not clear where the preamble ends now that the first instance “comprising” was deleted. It no clear what is meant by “further comprising” relative to the preamble.
Claim 1 lists “(ii) a camera or equivalent or a two-dimensional (2D) sensor or equivalent capable of focusing on or capturing images of or detecting light emitted from the two-dimensional (2D) sensor or equivalent” is not clear what would be deemed as equivalent.
Claim 1 recites the limitation "the excitation beam" on page 3 of the claims. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the functionalized surface" on page 3 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 (ii) states “capturing images or detecting light emitted from the two-dimension (2D) sensor or equivalent but does not include the “camera or equivalent” and is therefore unclear.
Claim 1(ii) reintroduces “an assay surface or sample slide” and is therefore unclear.
Claim 1(iii) reintroduces “an assay surface or sample slide” and is therefore unclear.
Claim 1(b)(iv) includes “the functionalized surface or sample slide” but is silent to the “assay” and is therefore unclear.
Claims 1(b)(iv), 4, 9 state “the sample holder or cuvette or equivalent” and it is not clear what would be deemed as equivalent.
Claim 1(b)(iv) introduces “sample illumination…provided by one or multiple light sources” but is incongruous with (i) sample illumination…device…to produce an excitation light.
Claim 1(c) introduces “a source of light or illumination or an excitation light or excitation beam” but this is incongruent with “(i) a sample illumination or sample luminescence, fluorescence or phosphorescent excitation device capable of or fabricated to produce an excitation light or excitation beam.”
Claim 1(c) is not clear how “fabricated to have” is a product or system and this is a step of fabrication”
Claim 1 (c) includes “a cell, pump, and optionally sample holder”. The “optionally” language is unclear when the operative linking of the pump as later detailed is requiring all three components.
Claim 2 requires a “step” which is again incongruent with device, product of manufacture or apparatus. Further it’s unclear if this is a new component or tied to the one in claim 1.
Claim 3 states “the imaging system and imaging detection comprises the CCD”, it not clear which it is a system or a detection as it cannot be both.
Claim 3 states “an about 0.2 to 200 megapixels charge-coupled device (CCD) or a Complementary Metal Oxide Semiconductor (CMOS) color or monochrome camera” however it is not clear if this is the same as the “(ii) a camera or equivalent or a two-dimensional (2D) sensor or equivalent capable of focusing on or capturing images of or detecting light emitted from the two-dimensional (2D) sensor or equivalent”.
Claim 4 recites the limitation "the sample slide, biochip, or microarray”" on page 8 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recited “the sample slide” or is silent to the “functionalized surface and assay surface”.
Claim 5 recites the limitation "one or multiple light sources" on page 8 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “the imaging system” which is incongruent with the manufacture, device, apparatus or system.
Claim 8 recites “the firmware and/or software or computer program” is incongruent with the manufacture, device, apparatus, or system”.
Claims 9 recites “wired or wireless or equivalent” and it is not clear what would be deemed as equivalent.
Claim 10 recites “the processing software” is incongruent with the manufacture, device, apparatus, or system”.
Claim 10 recites the limitation "the processing software" on page 11 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the computation of fluorescence …" on page 11 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the distinct target analyte" on page 11 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "a surface or the sample slide" on page 13 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Clam 14 reintroduces “a target analyte”, it is not clear is this is the same target analyte as introduced in claim 1.
Claim 15, recited “fabricated as a portable device” which is incongruent with “device, apparatus or system”.
Claim 16 recited “fabricated as a cuvette or equivalent” which is incongruent with a “a device, apparatus or system”.
Claim 16 recites the limitation "the source of light or illumination" on page 14 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the liquid solution" on page 14 of the clams. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “optionally a protein” it is not clear what the “composition” is.
Claims 2-16, 19, 20 and 22-23 are dependent upon claim 1 and fail to cure the deficiencies noted above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-8, 10, 13-16, 19-20, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ozcan (US 2013/0157351; June 20, 2013) in view of Luecken (US 20150069231, March 12, 2015).
Regarding claim 1, Ozcan discloses a product of manufacture, a device, an apparatus or a system for testing for the presence of a target analyte in a sample,
(a) a functionalized surface, an assay surface or a sample slide (Paragraph 4, Figure 3A, Element 76), (b) an imaging system capable of imaging a sample in a solution or on a hard surface (Paragraph 46, 56-59) comprising:
(i) a sample illumination or sample luminescence, fluorescence or phosphorescent excitation device capable of or fabricated to produce an excitation light or excitation beam (Figure 3A Elements 60; Paragraph 56-59), (ii) a camera or equivalent or a two-dimensional (2D) sensor or equivalent capable of focusing on or capturing images of or detecting light emitted from the two-dimensional (2D) sensor or equivalent and the
functionalized surface, an assay surface or a sample slide (Figures 3C, 4 Element 12 ; Paragraphs 56-60); (iii) one or a plurality of lenses (Paragraph 56-60, Figures 3A, 4 Element 64) for image magnification and focusing the excitation beam aligned between the camera or equivalent or the two-dimensional (2D) sensor or equivalent and the functionalized surface,an assay surface or a sample slide; one or a plurality of optical filters to define excitation and detection spectral windows (Paragraph 56 - Filter); and,
(iv) a sample holder, wherein the functionalized surface or sample slide is loaded or positioned onto or into the sample holder or cuvette or equivalent (Paragraph 56-60, Figures 3A, 4 Element 66, 76), and the sample illumination or sample luminescence,
fluorescence or phosphorescent excitation are provided by one or multiple light sources in the form of epi-illumination or in the form of a light sheet, and luminescent, fluorescence or phosphorescent images are detected with the camera or 2D sensor equivalent (Paragraphs 56-60), and (c) a firmware and/or software or computer program to acquire, store and process images from the imaging system in a manner suitable for storing, identifying, quantifying and optionally classifying target analytes (Paragraph 60 - digital processing of the image) wherein the device further comprises or is fabricated to have:
a hollow tubing (Paragraphs 56-60; Figures 4 Element 74) for flowing or moving a liquid sample, wherein the hollow tubing is operatively linked to a transparent sample flow cell (Paragraphs 56-60, Figure 4 Element 76), a pump and optionally an automated axial sample holder (optional), wherein a liquid sample flows through the hollow tubing, the transparent sample flow cell and the pump (Paragraph 56-60 93);
a pump (Paragraph 57 syringe pump) operatively linked to the hollow tubing, wherein flow of a liquid in and through the hollow tubing and the transparent sample flow cell is controlled and driven by the pump (Paragraphs 56-60, 93),
an axial sample holder and, wherein movement of the automated axial sample holder is controlled, and the axial sample holder positions the transparent sample flow cell before a source of light or illumination or an excitation light or excitation beam (Paragraph 52).
However, Ozcan does not disclose an automated axial sample holder and a mechano-electric component, wherein movement of the automated axial sample holder is controlled by the mechano-electric component, and the automated axial sample holder positions the transparent sample flow cell before a source of light or illumination or an excitation light or excitation beam.
Luecken discloses an automated axial sample holder and a mechano-electric component, wherein movement of the automated axial sample holder is controlled by the mechano-electric component, and the automated axial sample holder positions the transparent sample flow cell before a source of light or illumination or an excitation light or excitation beam. (Paragraph 43)
Therefore, from the teaching of Luecken, it would have been obvious at the time of filing to specify the abovementioned limitation since it is a known feature required for accurate sample positioning to allow for increased detection accuracy of samples.
Regarding claim 2, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses further comprising a step: (d) a software and/or a computer program to visualize, analyze, share and/or store data representing the images (Paragraphs 94-105).
Regarding claim 3, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein the imaging system, and imaging detection, comprises an about 0.2 to 200 megapixels charge-coupled device (CCD) or a Complementary Metal Oxide Semiconductor (CMOS) color or monochrome camera (Paragraph 68- CMOS, Figure 3A, 4) coupled to a lens or lens system (Paragraph 68- Lens, Figure 3A, 4) of between about 1 mm to about 1400 mm focal length to yield a field of view of between about 1 mm to about 75 mm with a pixel size at the sample of between about 0.1 pm to 100 pm for 2D imaging of: surfaces with epi-illumination, or solutions with light sheet illumination (Paragraph 68).
Regarding claim 4, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses herein the slide holder or cuvette or equivalent comprises a slot or slide insert to accurately position the sample slide, biochip or microarray for imaging (Paragraph 47, Figure 1C Elements 34).
Regarding claim 5, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein the sample slide is illuminated by one or more light sources (Paragraphs 56-60, Figures 3A, 4 Element 58) from the top, bottom and/or side at an angle of between about 0* to 90* to the optical axis or with a light sheet at an angle of between about 60* to 120* to the signal detection axis with the one or multiple light sources. (Paragraphs 56-60, Figures 3A, 4 Element 58)
Regarding claim 6, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 5. Ozcan further discloses wherein illumination comprises or the light source emits epi-illumination, or the illumination comprises or the light source emits light in the form of a sheet or single plane of light at the sample plane. (Paragraphs 47,52, 56-60, Figures 3A, 4 Element 58)
Regarding claim 7, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein the components of the imaging system are designed or fabricated to image surfaces, slides, biochips, microarrays or other target analytes in a sample or solution stained with a detectable dye or particle (Paragraph 104 – fluorescent dye).
Regarding claim 8, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein the firmware and/or software or computer program used to acquire, store and process images from the imaging system in a manner suitable for storing, identifying, quantifying and optionally classifying target analytes comprises a firmware and/or computer software to interface with the camera or 2D imaging equivalent (Paragraphs 94-105).
Regarding claim 10, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein a wired or wireless connection or equivalent is used to transfer image data to an online server and/or a cloud-based system (Paragraph 53).
Regarding claim 13, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses the target analytes are captured or affixed on a surface or the sample slide (Paragraph 46, 56-59 – Figure 1C Sample).
Regarding claim 14, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein a target analyte is directly labeled with a detectable dye or a nanoparticle prior to immobilizing or affixing onto a surface for analysis, or the target analyte is analyzed directly in solution (Paragraph 48 – Inherent as needed for fluorescence detection).
Regarding claim 15, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses fabricated as a portable device (Paragraph 43, 56-59).
Regarding claim 16, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses wherein (a) the sample holder; and optionally the transparent sample flow cell is or is fabricated as a cuvette or equivalent (Paragraph 46, 56-59), (b) the source of light or illumination is or is fabricated as a sample illumination or sample luminescence, fluorescence or phosphorescent excitation device capable of or fabricated to produce an excitation light or excitation beam (Paragraph 46, 56-59), or (c) in combination with flowing the liquid solution through the transparent sample flow cell a volume of liquid is imaged with the ability to detect the presence of a particle (Paragraph 46, 56-59).
Ozcan does not disclose (a) the automated axial sample holder comprises or
is fabricated as a piezo actuator or voice coiI actuator.
Luecken discloses (a) the automated axial sample holder comprises or
is fabricated as a piezo actuator or voice coiI actuator. (Paragraph 43)
Therefore from the teaching of Luecken, it would have been obvious at the time of filing to specify the abovementioned limitation since it is a known feature required for accurate sample positioning to allow for increased detection accuracy of samples.
Regarding claim 19, Ozcan in view of Leuckan disclose a product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses a method for detecting one or a plurality of biomarkers (Paragraph 56-60, Figures 3A, 4 Element 66, 76), (a) providing of having provided a product of manufacture, device, apparatus or system of claim 1 (Paragraph 56-60, Figures 3A, 4 Element 66, 76); (b) contacting the product of manufacture, device, apparatus or system with a biological sample or a sample derived from a biological source comprising a target analyte (Paragraph 56-60, Figures 3A, 4 Element 66, 76) (c) determining if the biological sample or the sample derived from the biological source comprises a composition (optionally a protein) that
specifically binds to a target analyte affixed on the product of manufacture,
device, apparatus or system (Paragraph 56-60, Figures 3A, 4 Element 66, 76).
Regarding claim 20, Ozcan in view of Leuckan disclose the method of claim 19. Ozcan further discloses wherein the target analyte comprises or is a substantially stained or detectably labeled target analyte (Paragraph 104 – fluorescent dye).
Regarding claim 22, Ozcan discloses a product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses a method for treating or ameliorating a disease, a condition, or a viral or a microbial infection, comprising:
(a) testing or screening an individual in need thereof with a product of manufacture, device, apparatus or system of claim 1, to determine if the individual in need thereof is infected with a pathogen, a virus or a microbe, or has a disease or condition. (Paragraphs 56-60, 104-106).
The Ozcan in view of Leuckan does not disclose (b) and if the individual in need thereof is found to be infected with the pathogen, the virus or microbe, or is determined to have or is diagnosed with the disease or condition, administering a drug or a treatment or agent for ameliorating or decreasing the symptoms of the disease, condition, pathogen virus or microbe, or administering a drug or a treatment to treat or ameliorate or decrease the symptoms of a condition, disease, infection or symptom caused by the pathogen, virus or microbe.
However, the Examiner takes official notice that a PHOSITA at the time of filing would have specified the abovementioned limitations since there are very commonly known method of the next steps once a patient is determined to be ill or infected with a pathogen or virus in order to ensure the patient gets healthy.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ozcan (US 2013/0157351; June 20, 2013) in view of Luecken (US 20150069231, March 12, 2015) in view of Murakami (US 2015/0310613 A1; October 29, 2015).
Regarding claim 9, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1. Ozcan further discloses does not disclose wherein a barcode attached or printed on the sample slide or cuvette or equivalent.
Murakami discloses wherein a barcode attached or printed on the sample slide or cuvette or equivalent. (Paragraph 341)
Therefore, from the teaching Murakami, it would have been obvious to a PHOSITA at the time of filing to specify the abovementioned limitations in order to allow for fast and accurate identification of a certain sample which allows for efficient sample processing.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ozcan (US 2013/0157351; June 20, 2013) in view of Luecken (US 20150069231, March 12, 2015) in view of Ramm (US 2002/0159162 A1; October 31, 2002).
Regarding claim 11, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1 but fails to disclose wherein the processing software comprises data comprising the computation of fluorescence, luminescence or phosphorescence intensity values for each spot or particle on a surface or in a 2D plane within a solution by calculating the mean or median value of the intensity distribution within the spot area.
Ramm further discloses wherein the processing software comprises data comprising the computation of fluorescence, luminescence or phosphorescence intensity values for each spot or particle on a surface or in a 2D plane within a solution by calculating the mean or median value of the intensity distribution within the spot area (Paragraph 111, 132, 195).
Therefore, from the teaching of Ramm, it would have been obvious at the time of filing to specify the abovementioned limitation in order to accurately quantify the target analyte using a known method.
Regarding claim 12, Ozcan in view of Luecken disclose the product of manufacture, device, apparatus or system of claim 1, but fails to disclose wherein the distinct target analyte comprises a distinct protein.
Ramm further discloses wherein the distinct target analyte comprises a distinct protein (Paragraph 10).
Therefore, from the teaching of Ramm, it would have been obvious at the time of filing to specify the abovementioned limitation since proteins are known target analytes can may need rapid scanning for detection of illness
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ozcan (US 2013/0157351; June 20, 2013) in view of Luecken (US 20150069231, March 12, 2015) in view of Hafeman (US 20060211055; 09/21/2006).
Regarding claim 23, Ozcan in view of Luecken discloses (a) a product of manufacture, device, apparatus or system of any of claim 1. Ozcan in view of Luecken does not disclose a kit comprising:
(b) at least one set of buffer or media suitable for binding and washing; (c) at least one set of detectable dyes or particles.
Hafemen discloses a kit comprising:
(b) at least one set of buffer or media suitable for binding and washing; (c) at least one set of detectable dyes or particles. (Paragraph 44)
Therefore, from the teaching of Hafemen, it would have been obvious to one having ordinary skill in art at the time of filing to a PHOSITA to specify the abovementioned limitations it is it a known materials needed for detecting a specimen that delivers high detection accuracy and efficiency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-US 20120157160A1 discloses a compact wide-filed fluorescent imaging on a mobile device.
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 GISSELLE GUTIERREZ whose telephone number is (571)272-4672. The examiner can normally be reached M-F 8-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached at 571-272-2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GISSELLE GUTIERREZ/
Examiner
Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884