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 .
Detailed Action
Summary
This is the Non-Final Office action based on the 18/725649 claims filed 12/09/2024.
Claims 1- 16 are cancelled.
Claims 17-22 are pending and have been fully considered.
This application has been examined as part of the PBA program.
Claim Objections
Claim 18 -20 are objected to because of the following informalities:
The claims contain the abbreviations GA, BCP, and FAOD, however all of these abbreviations other than what applicant intends them to mean as shown in the instant specification. Though it is clear from the specification what applicant intends, applicant should correct this issue. Appropriate correction is required.
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 17-22 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 17 contains limitations which are components “e/f,” and “ step g/h,” but only one component is claimed in each. This makes it unclear if another unnamed step is required or not or if instead this is a typo. Appropriate correction is required.
Further with respect to Claim 17, step a) requires a blood cell component with non-blood cell component in parentheses. If applicant is trying to clarify that the first component is not a blood cell component, then labeling it a blood cell component is confusing. Therefore, it is unclear if the component is supposed to be a blood cell component or not.
Further with respect to Claim 17, component b), it is unclear what is anything, that applicant is trying to convey by putting “blood cell component,” in parentheses next to “second blood cell component.”
For component d) in Claim 17 it is unclear what if any difference there is between a “hemolytic agent storage well,” and a “hemolytic agent well.”
With respect to Claim 20, it contains component e, f, g, and h, however components e/f and g/h were already claimed in Claim 17 which Claim 20 is dependent on and already contained these labeled components. Therefore, it is unclear if these trying to further limit the already claimed components or if instead these are completely different components.
Further with respect to Claim 20, FPOX is not an abbreviation for oxidase, so it is unclear if applicant is trying to limit the claims to this or not.
Claims 18-22 are also rejected by virtue of their dependency on Claim 17.
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 non-obviousness.
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.
Claims 17-18, 20-21 are rejected under U.S.C. 103 as being obvious by HOLMES in US 20160069919 in view of KOBAYASHI in WO 2019207724 A1.
With respect to Claim 17, HOLMES teaches of an assay station or cartridge (which can be considered a pipette cartridge) configured to support a sample collection unit (paragraph 0237-0238). HOLMES teaches that the cartridge can be a pipette cartridge in that it contains many different reagents and also pipette tips (paragraph 0259). HOLMES also teaches that the device can be configured for automatic dispensing (paragraph 0655).
HOLMES further teaches of the device being a microtiter plate or substrate with many wells or cavities, and specifically up to 50,000 wells or cavities (paragraph 1147-1150, 0202). This reads on the claimed 8 separate wells as instantly claimed.
HOLMES teaches that the cartridge can contain two or more different types of biological samples (paragraph 0254), so including blood- which can be considered to be a blood cell component, and also urine or saliva or nasal wash, which can be considered to be non blood cell components.
HOLMES teaches that the wells may or may not have filters (paragraph 1391), so this reads on the structures claimed for Claim 17 component (a) and (b), and further that other wells can contain diluent or reagents, so this makes the claimed diluent and first and second reagent wells obvious (paragraph 0447). Specifically, HOLMES also teaches that the cartridge contains 3 or more different reagents (paragraph 0259) and also dilutents (paragraph 0433).
HOLMES also teaches that hemolysis can occur in the wells, which means they must include a hemolytic agents (paragraph 2133).
Even further, HOLMES teaches that multiple wells /vessels may be configured for optical measurements so this reads on the two claimed optical measuring wells (paragraph 1049, 0464, 1389, 1391).
Though it is made obvious as shown above, since HOLMES does not call out specifically storing a hemolytic agent in the cartridge, KOBAYASHI is used to remedy this.
KOBAYASHI teaches of a device including a blood separation component for separating a trace amount of blood into blood cells and non-blood cells by using a filter to carry out a plasma component analysis; and causing a hemolytic agent to flow through the filter to hemolyze the blood cell components captured in the filter to carry out a blood cell component analysis ( abstract & Claim 22) .
KOBAYAHSHI further teaches of using a trace amount of blood (see the examples); measuring glucose ; and carrying out a HbA1c measurement ; and also a device comprising a blood cell analysis unit, a plasma analysis unit, a hemolytic-agent storage part, a filter, and a flow path (see the embodiments and drawings). Specifically KOBAYASHI teaches of using a hemolytic agent (Page 2, first paragraph comprising 1-d, wherein it is in something that can be considered a well through broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use the hemolytic agent and put it in a well as is done in KOBAYASHI in the device of HOLMES due to the advantage this has for hemolyzing cells (Page 2, first a paragraph, B).
With respect to Claim 18, HOLMES teaches of analyzing glucose as an assay analyte in the wells (paragraph 1792) and hemoglobin(paragraph 1829, 1838, 1908) and more specifically of Hb1Ac ( a type of hemoglobin)(paragraph 1792).
With respect to Claim 20, HOLMES teaches that the device can contain assays that include (Bromocresol Purple/BCP)(paragraph 1847), and protease (paragraph 1779-1780), and that denaturation can be performed with a denaturer (paragraph 0830, 1657), and that peroxidase (paragraph 1767) and other oxidases can be used (paragraph 1779) and also proteases (paragraph 177—1780) and further of using reagents that produce a color change/color former for colorimetry(paragraph 141).
With respect to Claim 21, HOLMES teaches of the device having an electrochemical sensor (paragraph 0397, 1938).
Claims 19 & 22 are rejected under U.S.C. 103 as being obvious by HOLMES in US US 20160069919 in view of KOBAYASHI in WO 2019207724 A1 and further in view of HIRAO in US 20110195444.
With respect to Claim 19, HOLMES teaches of the analyte being albumin(paragraph 1792, 1829), but not specifically GA (glycoalbumin). KOYBAYASHI also does not teach of this.
HIRAO is used to remedy this and teaches of a sensor and kit for measuring a glycosylated protein which can include glycosylated albumin (GA) and also FAOD(paragraphs 0043-0044).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to measure FAOD and GA as is dine on HIRAO in the devices of HOLMES and KOBAYASHI due to the advantage measuring the glycosylated proteins of which FAOD and GA are both one of has for reflecting glucose quality and glycemic control for diabetics (HIRAO, paragraph 0002).
With respect to Claim 22, HOLMES teaches of the device having an electrochemical sensor (paragraph 0397, 1938), and of the device being able to sense hydrogen peroxide (paragraph 1832, 1910). HOLMES also teaches that the device can contain membranes (paragraph 0193, 0196), but does not teach of specifically related to FAOD though this is intended use as claimed. KOYBAYASHI also does not teach of this.
HIRAO is used to remedy this and teaches of a sensor and kit for measuring a glycosylated protein which can include glycosylated albumin (GA) and also FAOD(paragraphs 0043-0044).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to measure FAOD and GA as is dine on HIRAO in the devices of HOLMES and KOBAYASHI due to the advantage measuring the glycosylated proteins of which FAOD and GA are both one of has for reflecting glucose quality and glycemic control for diabetics (HIRAO, paragraph 0002).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
