DETAILED CORRESPONDENCE
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 .
Election/Restriction
Newly submitted claim 52 (hereinafter “group II”) and claim 53 (hereinafter “group III”) are directed to an invention that is independent or distinct from the invention originally claimed (hereinafter “originally claimed group I”) for the following reasons:
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Originally claimed group I, and newly presented groups II and III lack unity of invention because even though the inventions of these groups require the technical feature of a test cartridge with a single use diagnostic strip, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Tyrrell et al (US 20160077091; hereinafter “Tyrrell”; already of record). Tyrrell teaches a test cartridge with a single use diagnostic strip (Tyrell teaches a cartridge with a test strip, where the cartridge can include a housing or a cartridge receptor; Fig. 1, 2, [99-103, 145, 150]. Tyrell teaches a codes/labels as configurable parameter modules which store information; [145, 150, 153]). The examiner notes that the newly presented claims (groups II and III) have been compared to originally presented group I. However, the examiner also notes that the newly presented groups II and III still remain distinct from amended and originally elected group I (claim 1) as there are many features that are mutually exclusive, but also only include the common technical feature of a test cartridge with a test strip and a component with a configurable parameter module, where the device receives information corresponding to the configuration parameter and configures the analyzer, which is taught by Taran, A (US 20210263018; hereinafter “Taran”; already of record). Taran teaches a test cartridge with a test strip and a component with a configurable parameter module, where the device receives information corresponding to the configuration parameter and configures the analyzer (Taran teaches a cartridge with a test strip; [24, 30-34, 83, 113, 115], Fig. 7 and also Figs 12-15. Taran teaches an analyzer as a diagnostic device which reads the QR code or RFID and analyzes the test strips and would include a controller to evaluate the processing software; [121, 122]. The examiner is interpreting the configurable parameter module to be any structure that is capable of providing an analyzer with information. Taran teaches imaging the QR code or RFID or position lines/dots which then help determine various testing parameters to be performed on the cartridge/strip and then running the specific test using the configured parameters for that particular cartridge/strip; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]. When Taran would read the configurable parameter information, then it would retrieve the specific information from storage and then select/configure the appropriate protocol for testing. The instant specification describes that algorithm as including tabular form in [16], which would be a table of parameters. Taran teaches various parameters, which could be tabular form as an algorithm, but Taran also teaches accessing various information which includes calibration data/curves and kinetic data which would be stored via some type of algorithm. Further, the examiner notes that all information that is stored in a memory, is formatted, stored, and read via an algorithm).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 52-53 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
As to the amended claims, filed on 9/9/25, the previous claim objections are withdrawn.
Regarding the claim amendments and remarks filed on 9/9/25, the previous 101 rejection has been modified to address the claim amendments.
Based on the claim amendments, new 112 rejections have been added.
Regarding the claim amendments and remarks filed on 9/9/25, the previous prior art rejection based on Tyrell has been withdrawn and the previous prior art rejection has been modified to address the claim amendments.
Claim Status
Claims 1, 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51-53 are pending with claims 52-53 being withdrawn and claims 1, 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 being examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The instant specification does not describe the “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1. Therefore, there is no specific correlation of the means/module to the structure configured to perform the function as required under 112(f). Applicants describe that logical modules exist that can be implemented in the form of instructions in [44] of the instant specification. However, it is unclear what structure applicants may or may not be attempting to impart on the “association module” since it is not described in the specification. For purposes of examination, the examiner will interpret the “association module” to be defined by computer programming to perform the claimed function.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 101 for the following reasons:
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract idea of “select algorithm files” in line 22 and then and appears to make a determination (claim is unclear under 112(b)- see below) via “the determined configuration parameter” in the last line. Both the selecting and determining would be considered mental processes, and further the algorithm is considered math, which each encompass abstract ideas.
MPEP 2106.04(a)(2)III is states that using a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. After selecting the algorithm (and similarly, determining the configuration), the analyzer is configured to perform a test “based on the determined configuration parameter” and also to “use the selected files” to perform the test. That the analyzer is configured “based on” the determination and to perform the test “using” the selection amounts to just generally “applying” the abstract idea per MPEP 2106.05(f), and also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
The abstract ideas are done by a controller which appears to be a general-purpose computer [0050]. A general-purpose computer, however, is not a particular machine, and performing the abstract idea on a general-purpose computer does not integrate the abstract idea into a particular practical application. See MPEP 2106.05(b), I.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of (1) a test cartridge comprising: (i) a first component comprising a first body at least partially enclosing a single-use diagnostic test strip wherein the single-use diagnostic test strip is removable from the first component; and (ii) a second component comprising a second body, wherein the second body at least partially encloses the first component, the second component comprising a configurable parameter module wherein the outer enclosure is made of a thermally conductive material, wherein the first component is removable from the second component and the second component is reusable, and the configurable parameter module is an integrated circuit capable of storing and transmitting information through a wired or wireless connection, a radio frequency identification (RFID) tag, a visual tag with encoded information such as, a color-coded tag, a bar code, or any combinations thereof, the configurable parameter module stores parameter information associated with a first testing identification. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Taran, A (US 20210263018; hereinafter “Taran”; already of record). Taran teaches a configurable diagnostic test system (Taran; Abstract, Figs. 1, 2, 5-17, 33) (1) a test cartridge comprising: (i) a first component comprising a first body at least partially enclosing a single-use diagnostic test strip wherein the single-use diagnostic test strip is removable from the first component; and (ii) a second component comprising a second body, wherein the second body at least partially encloses the first component, the second component comprising a configurable parameter module wherein the outer enclosure is made of a thermally conductive material, wherein the first component is removable from the second component and the second component is reusable (Taran teaches a cartridge with a test strip; [24, 30-34, 83, 113, 115]. Taran teaches the first component as the bottom below the test strips and that partially encloses and holds a test strip on the bottom, and a second component as the upper component that partially encloses the top of the first/bottom component; Fig. 7 and also Figs 12-15. The components of Taran can be reused as desired as this limitation is towards intended use/function. Taran teaches the top second component as having a configurable parameter module as QR code, NFC, or RFID, or position lines/dots on the cartridge; [117-120, 197]. Taran teaches that the cartridge is made from plastic; [206]. Taran also teaches providing heat; [235]. The instant specification describes that resin (i.e. plastic) is thermally conductive material [52] and also describes any material that absorbs heat as satisfying the limitation of being thermally conductive [15]. Therefore, because all material absorb heat in some capacity, and given applicants broad definition, then Taran teaches a material which would absorb some heat), and the configurable parameter module is an integrated circuit capable of storing and transmitting information through a wired or wireless connection, a radio frequency identification (RFID) tag, a visual tag with encoded information such as, a color-coded tag, a bar code, or any combinations thereof (Taran teaches a configurable parameter module as QR code, NFC, or RFID, or position lines/dots on the cartridge; [117-120, 197].), the configurable parameter module stores parameter information associated with a first testing identification (Taran teaches storing information associated with first testing identification; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]).
The dependent claims 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 have been evaluated based on the above analysis and do not appear to resolve any of the above issues and are therefore similarly rejected as each of the elements recited in the dependent claims are WURC. See the 35 USC 102 rejection over Taran below which cites to where each of the additional elements are taught in Taran and are therefore WURC.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 limitation “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1 which is new matter as no “no “association module” is described anywhere in the specification/disclosure as originally filed. Further, “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The instant specification does not describe the “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1. Therefore, there is no specific correlation of the means/module to the structure configured to perform the function as required under 112(f). Applicants describe that logical modules exist that can be implemented in the form of instructions in [44] of the instant specification. However, it is unclear what structure applicants may or may not be attempting to impart on the “association module” since it is not described in the specification, and therefore the application fails to satisfy the written description requirement. For purposes of examination, the examiner will interpret the “association module” to be defined by computer programming to perform the claimed function.
Claims 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 are rejected based on further claim dependency.
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, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 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 pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what “the outer enclosure” is attempting to refer to in line 8 since no outer enclosure has previously been recited. Therefore, this limitation has insufficient antecedent basis and is unclear.
In regards to line 12 of claim 1, it is unclear what the limitation “such as a color-coded tag” is attempting to describe. Specifically, the term “such as” is exemplary claim language and it is unclear whether a broad recitation of a visual tag is sufficient to satisfy the claim limitation or whether the narrower color-coded tag is required to satisfy the claim limitation.
As to claim 1, it is unclear what “the determined configuration parameter” is attempting to refer to in line 25 since no determined configuration parameter has previously been recited. Therefore, this limitation has insufficient antecedent basis and is unclear.
Claim 1 limitation “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The instant specification does not describe the “association module”/ ”association module to select…” as recited in lines 16 and 22 of claim 1. Therefore, there is no specific correlation of the means/module to the structure configured to perform the function as required under 112(f). Applicants describe that logical modules exist that can be implemented in the form of instructions in [44] of the instant specification. However, it is unclear what structure applicants may or may not be attempting to impart on the “association module” since it is not described in the specification. For purposes of examination, the examiner will interpret the “association module” to be defined by computer programming to perform the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 are rejected based on further claim dependency.
Regarding claim 17, it is unclear what is attempting to be further defined beyond that which is defined in amended claim 1. Specifically, amended claim 1 appears to recite the limitations of claim 17, and it becomes unclear what, if any, limitations are attempting to be further added. Is “a first testing identification” somehow different from the previously recited identification of claim 1? The examiner is interpreting the limitations of claim 17 to be fully recited in claim 1, but requests clarification.
Regarding claim 18, it is unclear what is attempting to be further defined beyond that which is defined in amended claim 1. Specifically, amended claim 1 appears to recite the limitations of claim 18, and it becomes unclear what, if any, limitations are attempting to be further added. The examiner is interpreting the limitations of claim 18 to be fully recited in claim 1, but requests clarification.
As to claim 27, it is unclear what “the determined configuration parameter” is attempting to refer to in line 25 since no determined configuration parameter has previously been recited. Therefore, this limitation has insufficient antecedent basis and is unclear.
Appropriate correction and/or clarification is required.
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 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)(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.
Claims 1, 2, 6, 10, 13, 15, 17, 18, 25, 27, 28, 31, 48, 51 are rejected under 35 U.S.C. 102a2 as being anticipated by Taran, A (US 20210263018; hereinafter “Taran”; already of record).
As to claim 1, Taran teaches a configurable diagnostic test system (Taran; Abstract, Figs. 1, 2, 5-17, 33) comprising:
(1) a test cartridge comprising: (i) a first component comprising a first body at least partially enclosing a single-use diagnostic test strip wherein the single-use diagnostic test strip is removable from the first component; and (ii) a second component comprising a second body, wherein the second body at least partially encloses the first component, the second component comprising a configurable parameter module wherein the outer enclosure is made of a thermally conductive material, wherein the first component is removable from the second component and the second component is reusable (Taran teaches a cartridge with a test strip; [24, 30-34, 83, 113, 115]. Taran teaches the first component as the bottom below the test strips and that partially encloses and holds a test strip on the bottom, and a second component as the upper component that partially encloses the top of the first/bottom component; Fig. 7 and also Figs 12-15. The components of Taran can be reused as desired as this limitation is towards intended use/function. Taran teaches the top second component as having a configurable parameter module as QR code, NFC, or RFID, or position lines/dots on the cartridge; [117-120, 197]. Taran teaches that the cartridge is made from plastic; [206]. Taran also teaches providing heat; [235]. The instant specification describes that resin (i.e. plastic) is thermally conductive material [52] and also describes any material that absorbs heat as satisfying the limitation of being thermally conductive [15]. Therefore, because all material absorb heat in some capacity, and given applicants broad definition, then Taran teaches a material which would absorb some heat), and the configurable parameter module is an integrated circuit capable of storing and transmitting information through a wired or wireless connection, a radio frequency identification (RFID) tag, a visual tag with encoded information such as, a color-coded tag, a bar code, or any combinations thereof (Taran teaches a configurable parameter module as QR code, NFC, or RFID, or position lines/dots on the cartridge; [117-120, 197].), the configurable parameter module stores parameter information associated with a first testing identification (Taran teaches storing information associated with first testing identification; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]), wherein the stored parameter information is configured to be erased, removed, reused, or uploaded (The stored parameter is not positively recited as part of the system and is a function of the configurable parameter module. Taran teaches various information that could be erased from the computer or removed or uploaded; [118, 119, 159, 185, 187, 197, 199, 262, 265, 323, 367-376]) and
(2) an analyzer comprising written algorithm files, an association module, a display screen, storage, and a diagnostic controller the diagnostic controller communicatively coupled with the configurable parameter module of the second component of the test cartridge (Taran teaches an analyzer as a diagnostic device which reads the QR code or RFID and analyzes the test strips and would include a controller to evaluate the processing software; [121, 122]. The examiner is interpreting the configurable parameter module to be any structure that is capable of providing an analyzer with information. Taran teaches a display; Fig. 35, [276].), wherein the diagnostic controller is configured to: (i) retrieve written algorithm files from storage: (ii) direct the association module to select specific algorithm files associated with the test cartridge:(iii) use the selected algorithm files to configure the analyzer to perform a test on the test cartridge based on the determined configuration parameter (Taran teaches imaging the QR code or RFID or position lines/dots which then help determine various testing parameters to be performed on the cartridge/strip and then running the specific test using the configured parameters for that particular cartridge/strip; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]. When Taran would read the configurable parameter information, then it would retrieve the specific information from storage and then select/configure the appropriate protocol for testing. The instant specification describes that algorithm as including tabular form in [16], which would be a table of parameters. Taran teaches various parameters, which could be tabular form as an algorithm, but Taran also teaches accessing various information which includes calibration data/curves and kinetic data which would be stored via some type of algorithm. Further, the examiner notes that all information that is stored in a memory, is formatted, stored, and read via an algorithm).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”, “capable of…”, etc…). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Taran teaches the configurable diagnostic test system of claim 1, wherein the analyzer is handheld (The instant limitations are related to intended use/function of the analyzer and the analyzer of Taran is capable of this. Taran; [38]).
As to claim 6, Taran teaches the configurable diagnostic test system of claim 2, wherein the second component comprises at least one aperture to detect a chemical reaction at the single-use diagnostic test strip, wherein the at least one aperture is covered (Taran teaches an aperture in the cartridge to allow access to the test strip; Fig. 5, 7, 8, 13, 27. The apertures are covered by the analytical device when placed therein. Taran also teaches LEDs covering the aperture; Fig. 27, [205]).
As to claim 10, Taran teaches the configurable diagnostic test system of claim 1, wherein the analyzer further comprises one or more detectors (Taran; [112, 121, 122-132]).
As to claim 13, Taran teaches the configurable diagnostic test system of claim 1, wherein the single use diagnostic test strip is configured to have at least one diagnostic test conducted thereon (Taran; [112, 121, 122-132, 158]).
As to claim 15, Taran teaches the configurable diagnostic test system of claim 13, wherein the single-use diagnostic test strip comprises a chemical reaction that produces a signal that is detectable by the analyzer (Taran; [112, 121, 122-132, 158]).
As to claim 17, Taran teaches the configurable diagnostic test system of claim 1, wherein the configurable parameter module stores parameter information associated with a first testing identification (Taran; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]).
As to claim 18, Taran teaches the configurable diagnostic test system of claim 17, wherein the stored parameter information is configured to be erased, removed, reused, or uploaded (The stored parameter is not positively recited as part of the system and is a function of the configurable parameter module. Taran teaches various information that could be erased from the computer or removed or uploaded; [118, 119, 159, 185, 187, 197, 199, 262, 265, 323, 367-376]).
As to claim 25, Taran teaches the configurable diagnostic test system of claim 1, wherein the analyzer is configured to detect changes in signals (The instant limitations are related to intended use/function of the analyzer and the analyzer of Taran is capable of this. Taran teaches the analysis over time which would detect changes in signals via the detectors; [112, 121, 122-132, 158]).
As to claim 27, Taran teaches the configurable diagnostic test system of claim 1, wherein the analyzer is configured to: based on the determined configuration parameter, access an executable method file; and based on the executable method file, configure the analyzer to perform the test on the single-use diagnostic test strip using a particular set of test conditions (The instant limitations are related to intended use/function of the analyzer and the analyzer of Taran is capable of this. Taran teaches imaging the QR code or RFID or position lines/dots which then help determine various testing parameters to be performed on the cartridge/strip and then running the specific test using the configured parameters for that particular cartridge/strip; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]. Taran teaches using testing parameters that are accessed in the system memory; [155, 156, 159, 179-180, 245, 323]).
As to claim 28, Taran teaches the configurable diagnostic test system of claim 1, wherein the analyzer comprises a cartridge heating component (Taran teaches a heater for temperature control; [235]).
As to claim 31, Taran teaches the configurable diagnostic test system of claim 1, wherein the test cartridge is removable and is able to be replaced with a second test cartridge (The instant limitations are related to intended use/function of the analyzer and the analyzer of Taran is capable of this. Taran teaches a cartridge inserted into the analyzer where the cartridge would be a consumable that is replaced with a second test cartridge; see claim 1 above).
As to claim 48, Taran teaches the configurable diagnostic test system of claim 1, wherein the configurable parameter module comprises a radio frequency identification (RFID) tag, a barcode, or a color-coded tag (Taran; [117-120]).
As to claim 51, Taran teaches the configurable diagnostic test system of claim 1, the test cartridge comprising a single-use diagnostic test strip comprising a plurality of test zones (Taran teaches reading multiple test lines on the same strip; [122-132, 157, 158, 298]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Heron (US 20220291205; hereinafter “Heron”; already of record) teaches QR code which stores specific parameters; [384].
Fleming (US 20160370366; hereinafter “Fleming; already of record) teaches reasons for info on ID code; [88].
Wachtell et al (US 20130136347; hereinafter “Wachtell”; already of record) teaches determining the configuration of the analyzer based on the label; [33].
Tyrrell et al (US 20160077091; hereinafter “Tyrrell”; already of record) teaches a cartridge with a test strip, where the cartridge can include a housing or a cartridge receptor; Fig. 1, 2, [99-103, 145, 150]. Tyrell teaches a codes/labels as configurable parameter modules which store information; [145, 150, 153]. Tyrell teaches a digital camera or smart phone, each which have a controller or can be separable or integrated with a computer; Fig. 1, 2, [99-101, 145]. The examiner is interpreting the configurable parameter module to be any structure that is capable of providing an analyzer with information. Tyrell teaches reading the label/code and determining various parameter configurations; [153]. Tyrell also teaches reading a bar code 710 which then gives the imaging protocol parameters based on the identification; Figs. 4-5 [160-162]. Tyrrell also teaches that a this directs the processing of specific zones in the image; [162].
Response to Arguments
Applicant's arguments filed 9/9/25 have been fully considered but they are not persuasive.
With respect to applicants arguments towards the 101 rejection, applicants argue on pages 8-10 that the claims are not directed towards a judicial exception. However, the examiner respectfully disagrees. Claim 1 recites the abstract idea of “select algorithm files” in line 22 and then and appears to make a determination (claim is unclear under 112(b)- see below) via “the determined configuration parameter” in the last line. Both the selecting and determining would be considered mental processes, and further the algorithm is considered math, which each encompass abstract ideas. MPEP 2106.04(a)(2)III is states that using a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea.
With respect to applicants arguments towards the 101 rejection, applicants argue on pages 10-12 that the claims are directed towards significantly more (step 2B). However, the examiner respectfully disagrees. Applicants argue that the additional structure of the cartridge amounts to significantly more. The examiner respectfully disagrees. Under step 2B, the claim recites the additional elements of (1) a test cartridge comprising: (i) a first component comprising a first body at least partially enclosing a single-use diagnostic test strip wherein the single-use diagnostic test strip is removable from the first component; and (ii) a second component comprising a second body, wherein the second body at least partially encloses the first component, the second component comprising a configurable parameter module wherein the outer enclosure is made of a thermally conductive material, wherein the first component is removable from the second component and the second component is reusable, and the configurable parameter module is an integrated circuit capable of storing and transmitting information through a wired or wireless connection, a radio frequency identification (RFID) tag, a visual tag with encoded information such as, a color-coded tag, a bar code, or any combinations thereof, the configurable parameter module stores parameter information associated with a first testing identification. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Taran, A (US 20210263018; hereinafter “Taran”). Taran teaches a configurable diagnostic test system (Taran; Abstract, Figs. 1, 2, 5-17, 33) (1) a test cartridge comprising: (i) a first component comprising a first body at least partially enclosing a single-use diagnostic test strip wherein the single-use diagnostic test strip is removable from the first component; and (ii) a second component comprising a second body, wherein the second body at least partially encloses the first component, the second component comprising a configurable parameter module wherein the outer enclosure is made of a thermally conductive material, wherein the first component is removable from the second component and the second component is reusable (Taran teaches a cartridge with a test strip; [24, 30-34, 83, 113, 115]. Taran teaches the first component as the bottom below the test strips and that partially encloses and holds a test strip on the bottom, and a second component as the upper component that partially encloses the top of the first/bottom component; Fig. 7 and also Figs 12-15. The components of Taran can be reused as desired as this limitation is towards intended use/function. Taran teaches the top second component as having a configurable parameter module as QR code, NFC, or RFID, or position lines/dots on the cartridge; [117-120, 197]. Taran teaches that the cartridge is made from plastic; [206]. Taran also teaches providing heat; [235]. The instant specification describes that resin (i.e. plastic) is thermally conductive material [52] and also describes any material that absorbs heat as satisfying the limitation of being thermally conductive [15]. Therefore, because all material absorb heat in some capacity, and given applicants broad definition, then Taran teaches a material which would absorb some heat), and the configurable parameter module is an integrated circuit capable of storing and transmitting information through a wired or wireless connection, a radio frequency identification (RFID) tag, a visual tag with encoded information such as, a color-coded tag, a bar code, or any combinations thereof (Taran teaches a configurable parameter module as QR code, NFC, or RFID, or position lines/dots on the cartridge; [117-120, 197].), the configurable parameter module stores parameter information associated with a first testing identification (Taran teaches storing information associated with first testing identification; [118, 119, 159, 185, 187, 197, 199, 323, 367-376]). Applicants also argue that there is a proposed improvement/solution by enabling the “selection” of algorithms. However, as stated previously, the selection of the algorithms is an abstract idea itself, and the improvement cannot be the abstract idea but must be in a particular technology. See MPEP 2106.05(a), paragraphs 4 - 7.
Applicant’s arguments with respect to the prior art rejection over Taran have been considered but are moot because the arguments are towards the amended claim limitations and not the current grounds of rejection. The examiner directs applicants attention to the prior art rejection based on Taran above for an explanation of how Taran teaches the claim amendments.
Conclusion
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 Benjamin R Whatley whose telephone number is (571)272-9892. The examiner can normally be reached on Mon- Fri 8am-5pm.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798