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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/30/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 21-23, 25 and 26 are objected to because of the following informalities: The claims recite “the sample vessel according to claims 14, 15, and 16”. However, the aforementioned claims from which they depend are method claims. It is clear from the subject matter of claims 21-23, 25 and 26 that the claims should depend from claims reciting the “sample vessel”. Appropriate correction is required.
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 1-3, 5, 6, 9, and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to method of determining the presence of a target species in a fluid sample without significantly more. The claims recite receiving a captured image, the image captured exposing a fluid sample to receive an optical property of the fluid sample, and determining whether a target species is present based on the optical property data. The broadest reasonable interpretation is that this process falls within the mental process groupings of abstract ideas because it covers concepts which may be practically performed in the human mind, including observation, evaluation, judgement and determination. The claimed subject matter implements a process of observing image data, evaluating the image to mentally evaluate a color of a mixture, judging whether the color is a specific color which represents a target species (e.g., disease) and determining the target species is present based on the color.
This judicial exception is not integrated into a practical application because the recitation of the method being “computer-implemented” merely indicates an apparatus for data gathering and outputting recited at a high level of generality and thus are insignificant extra-solution activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished; whether the claim invokes computers or other machinery merely as a tool to perform an existing process; and the particularity or generality of the application of the judicial exception. Even when considered in combination, these additional hardware elements represent mere general devices to implement the abstract idea or other exception on a computer, which do not provide an inventive concept.
Claim Rejections - 35 USC § 102
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 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)(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.
Claims 1, 2, 9, 14, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ian Gibbons et al (US 20160006928 A1).
Regarding claim 1, Gibbons et al discloses a computer-implemented method of determining the presence of a target species in a fluid sample (¶ [20]), the computer-implemented method comprising:
receiving a captured image including an image capture portion of a sample vessel (¶ [20]), the image capture portion exposing a fluid sample contained within the sample vessel (¶ [20]), wherein an optical property of the fluid sample is indicative of the presence of the target species (¶ [21] and ¶ [23]);
processing the captured image to generate optical property data representative of the optical property of the fluid sample (¶ [472] and ¶ [523-524]); and
determining whether the target species is present in the fluid sample based on the optical property data (¶ [472]).
Regarding claim 2, Gibbons et al discloses the computer-implemented method according to claim 1 (see rejection of claim 1) wherein:
the presence, expression or activity of the target species is associated with a status or progression of a disease (¶ [472] and ¶ [622]); or
the upregulated expression or activity of the target species is associated with a status or progression of a disease.
Regarding claim 9, discloses the computer-implemented method according to claim 1, wherein:
the optical property is a colour of the fluid sample (see rejection of claim 1); and
processing the captured image comprises determining the colour of the fluid sample in the fluid sample region of the captured image (¶ [472]).
Regarding claim 14, discloses a method of determining the presence of a target species in a fluid sample (see rejection of claim 1), the method including:
capturing an image including an image capture portion of a sample vessel (¶ [19]), the image capture portion exposing a fluid sample contained within the sample vessel, wherein an optical property of the fluid sample is indicative of the presence of the target species (¶ [472]); and
performing the computer-implemented method of claim 1 (see rejection of claim 1).
Regarding claim 15, Gibbons et al discloses the method according to claim 14 (see rejection of claim 14), further comprising:
obtaining the fluid sample in the sample vessel (¶ [191]), which comprises the steps of:
providing the sample vessel to a subject (¶ [191]), the sample vessel containing at least a first reagent (¶ [192]);
obtaining a sample of a bodily fluid from the subject in the sample vessel, the bodily fluid containing the target species to be tested (¶ [191-192] and ¶ [244]);
mixing at least the first reagent with the bodily fluid in the sample vessel, to provide the fluid sample (¶ [218]), wherein the optical property of the fluid sample depends on a degree of interaction between the first reagent and the target species (¶ [462] and ¶ [472]).
Claims 17 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Elizabeth Holmes et al (WO 2014088606 A2).
Regarding claim 17, Holmes et al discloses a sample vessel for collection of a bodily fluid from a subject, and for preparation of a fluid sample (¶ [249]), the sample vessel comprising:
a sample collection assembly (¶ [250]), including a sample collection element which is configured to receive and retain a sample of a bodily fluid from a subject (¶ [252] collection tubes);
a containment component including: an outer housing (¶ [271] common portions 1130 and 1140); an inner mechanism located inside the outer housing (¶ [271] fill portion 1120), the inner mechanism having an inner surface defining a cavity arranged to receive the sample collection element of the sample collection assembly (Fig. 11B); and a first reagent chamber (¶ [254] channel 1126);
wherein the sample collection assembly is positionable in the cavity in a testing position in which the sample collection element is in fluid communication with the first reagent chamber (¶ [276]).
Regarding claim 19, Holmes et al discloses the sample vessel according to claim 17 (see rejection of claim 17), wherein:
the containment component comprises a locking mechanism configured to limit or prevent relative axial movement between the sample collection assembly and the inner mechanism when the sample collection assembly is in the testing position (¶ [266] Fig. 11I)
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ian Gibbons et al (US 20160006928 A1) in view of Zachary Morrison et al (US 20170045729 A1).
Regarding claim 3, Gibbons et al discloses the computer-implemented method according to claim 1 (see rejection of claim 1).
Gibbons et al fails to explicitly disclose the captured image includes an identification code, which encodes additional data about the test, the additional data including one or more of an identity of the subject, a date/time at which the test is taken, a unique ID of the test session, information about the disease, information about the first reagent, information about the second reagent, and a test version; the identification code is located in the image capture region; and the captured image includes a fluid sample region in which the fluid sample is visible, and an identification code region in which the identification code is visible.
Morrison et al, in the same field of endeavor of imaging a fluid sample to collect visual information about a characteristic of the sample (¶ [16]), teaches the captured image includes an identification code (¶ [50]), which encodes additional data about the test, the additional data including one or more of an identity of the subject, a date/time at which the test is taken, a unique ID of the test session, information about the disease, information about the first reagent, information about the second reagent, and a test version (¶ [19]); the identification code is located in the image capture region (¶ [76]); and the captured image includes a fluid sample region in which the fluid sample is visible, and an identification code region in which the identification code is visible (¶ [76] and ¶ [78]).
It would have been obvious to one of ordinary skill in the art before the invention was effectively filed for the method as disclosed by Gibbons et al which discloses receiving a captured image including an image capture portion of a sample vessel and processing the captured image to generate optical property data representative of the optical property of the fluid sample to utilize the teachings of Morrison et al which teaches the captured image includes an identification code, which encodes additional data about the test, the additional data including one or more of an identity of the subject, a date/time at which the test is taken, a unique ID of the test session, information about the disease, information about the first reagent, information about the second reagent, and a test version; the identification code is located in the image capture region; and the captured image includes a fluid sample region in which the fluid sample is visible, and an identification code region in which the identification code is visible to verify the sample for one or more sample characteristics and notify any issues with the sample quality, integrity, volume or any other information needed prior to utilizing the sample for its intended purpose.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gibbons et al in view of Morrison et al as applied to claim 3 above, and further in view of Elizabeth Holmes et al (WO 2014088606 A2).
Regarding claim 5, Gibbons et al discloses the computer-implemented method according to claim 3 (see rejection of claim 3).
Gibbons et al fails to explicitly disclose the image capture region of the sample vessel is defined by the identification code; and the identification code includes a window through which the fluid sample is visible.
Holmes et al, in the same field of endeavor of fluid sample collection systems, devices and methods (Abstract), teaches the image capture region of the sample vessel is defined by the identification code (¶ [333-334]); and the identification code includes a window through which the fluid sample is visible (¶ [333-334]).
It would have been obvious to one of ordinary skill in the art before the invention was effectively filed for the method as disclosed by Gibbons et al which discloses receiving a captured image including an image capture portion of a sample vessel and processing the captured image to generate optical property data representative of the optical property of the fluid sample to utilize the teachings of Holmes et al which teaches the image capture region of the sample vessel is defined by the identification code; and the identification code includes a window through which the fluid sample is visible to enable easy and efficient capture of both the identifying information of the vessel as well as the sample collected.
Allowable Subject Matter
Claims 12, 18, 20 and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/JAMARES Q WASHINGTON/Primary Examiner, Art Unit 2681
December 27, 2025