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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on February 12th, 2026. Claims 1-20 are pending.
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:
Nanobody configured to bind red blood cells and cause non-antigen-specific agglutination…as in cl. 7
Nanobody configured to mimic a function of physiological antibodies…as in cl. 8
Nanobody configured to induce hemagglutination of the test fluid…as in cl. 9
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.
Unclear from the disclosure*
Unclear from the disclosure*
Unclear from the disclosure*
*see rejection under 35 USC 112 b/2nd below
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 § 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 7-9 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.
Applicant’s written disclosure inadequately provides basis for the recitations of claims 7-9 to the “nanobodies” configured for their particular, respective functionalities therein.
The disclosure provides generalized discussion to “nanobodies” and absent particulars thereto including definition and discussion with respect to their concordantly-claimed functionalities.
Examiner notes that the disclosure references “dromedary-derived antibody” and provides in parenthesis an inference of equating such to a “nanobody,” however this is both inadequate and appears incongruent as a nanobody and an antibody are different types of elements.
Further, it appears that Applicant is utilizing a registered trademark in the form of nanobody®, but has not provided such marking, nor a distinct definition or terminology to Applicant’s own “nanobody.”
Examiner notes par.[0083] describes GPA-directed nanobody IHF, but its ability in providing for the recited functionalities in claims 7-9 is inadequately described and shown.
The “examples” in par.[0132]+ that provide discussion to “nanobodies” are highly generalized and narrative without any particular discussion thereto to provide detailed information, experimental results, and particulars thereto such nanobodies configured as claimed.
Claims 18-20 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.
The specification inadequately describes the artificial intelligence model and its training.
The discussion thereto in the specification is at a high level of generality (see pars.[0036-0046,0065,0070-0075,0085-0088,0112-0118] of Applicant’s pre-grant publication US 2023/0024685.
Examiner notes that pars.[0090-0097] discusses a well-known object detection algorithm in YOLOV3 that uses CNN (convolutional neural network), but the training of this well-known object training algorithm to the particular functionality at-hand herein the claims is inadequately described as the training is described at a high level of generality.
Further, the “Examples” provided in pars.[0132]+ are highly generalized and absent particulars thereto.
Artificial intelligence and machine learning architecture are fundamentally defined by their architecture, training, and problem/solution offered.
With respect to the architecture, the specification provides only a high level of generality to application with “machine learning models” and “artificial intelligence model/algorithm” integration.
As discussed above, Examiner notes that there is a singular exemplification of “YOLOV3” that is a convolutional neural network but the disclosure is absent any particulars thereof to adequately describe and define such beyond the high level, known object finding algorithm and is without particulars thereto in the sought, claimed applications herein.
The specification is absent discussion to the particular machine learning/artificial intelligence architecture involved (i.e. Convolutional Neural Networks, Feedforward Neural Networks, Recurrent Neural Networks, Long Short-Term Memory Networks, Deep Neural Networks, etc…).
Further, the specification is absent discussion between the relationship of the problem to be solved (i.e. the image analysis for reaction agglutination) and particular architecture used to solve it.
Additionally, the disclosure is absent any technical details about the operation of the deep learning object detection model/artificial intelligence model/algorithm at the level of the layers, nodes, and activation functions, etc.
With respect to the training, the specification provides general discussion to “deep learning object model” and “artificial intelligence model/algorithm,” however, particular models and algorithms are not disclosed, nor is the particular training provided by the disclosure.
There is also general discussion to “training images” and but the disclosure does not go beyond these general inferences to provide specifics thereto in the present application.
Examiner notes par.[0097] and the particular discussion with respect to quantifying the presence of SARS-CoV-2 antibodies and neural network datasets over an 8-fold dilution range with a two-fold dilution corresponding to a distance of “2 neural network training datasets” in assessing a relationship between antibody titer and level of agglutination to provide a semi-quantitative assessment of antibody titers, but this Example is both somewhat prophetic and is not commensurate in scope with the breadth of the present claims.
For example, the specification is absent specifics related to the loss functions of a supervised machine learning process utilized.
With respect to the problem/solution offered, the artificial intelligence application herein is not provided with a technical problem, technical solution, and the resulting improvement over related technologies that is related to the technical problem.
The disclosure is absent a description of the structure that performs the functions claimed by the sought ‘trained artificial intelligence model,’ nor does the disclosure provide any model(s)/algorithm(s) for how the claimed function performs.
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 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As discussed above, “nanobody capable of…[x]…” as in claims 7-9 is construed under 35 USC 112 6th/F as providing an alternative-type “means for” recitation wherein “nanobody” represents a generic placeholder and absent sufficient structure thereto for its recited functionalities.
Herein, under 35 USC 112 b/2nd, in reviewing Applicant’s disclosure, the corresponding structure(s) and equivalents thereof are indefinitely defined and clarification is required.
Claims 7-9 contain the trademark/trade name nanobody®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the reagent and, accordingly, the identification/description is indefinite.
Nanbody® and Nanobodies® are trademarks owned by Ablynx N.V.
Claim 14 is 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.
The metes and bounds of the sought scannable codes are indefinitely defined by way of the amended recitation to claim 14.
Claim 14 is codified to instructions as in the one or more recited therein. However, as in claim 1, the image-capture instructions are drawn to “information relating to one or more of…” and are thus drawn to information/data.
Further, it is unclear how the alternative choices of the three instances of “instructions” correlate with the prior-established information relating to one or more of orientation, framing, exposure, white balance, or timing.
Clarification is required.
For purposes of examination, the recitation is construed coincident with the recitation of claim 1 wherein such image-capture instructions are drawn to “information relating to…”
It is further noted that this is in-line with the claims as a whole as the claims merely provide the information with prospective functionality for capture of an image, and further prospective discussion that such image is one that is suitable for computer-implemented image analysis by a machine learning algorithm. The claims are absent any sort of reader/processor and communicated camera/imager to receive and process such “information” and “information relating to” and affect a particular imaging acquisition and downstream analysis thereof.
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, 6, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond (USPN 3,853,468) in view of Scherr (US 2019/0257822).
Haymond discloses a method and apparatus for clinical testing of biological fluids (abstract). Haymond discloses a test card comprising a negative control test region 13 for receiving a negative test control fluid sample, a positive control test region 11 for receiving a positive control fluid sample, and a test sample region 12 for receiving a test fluid sample (lines 45-67, col. 2; line 35, col. 3 – line 20, col. 4, figures, for example). Haymond further discloses that comparison between the test area(s) and the positive and negative control areas can be done by visual inspection or by machine, and the top of the test card may bear a space to identify the test and a space to mark the date the test is made (lines 64-67, col. 4; lines 12-16, col. 5). With regard to claim 6, the recitation is drawn to an intended use recitation not afforded patentable weight.
With regard to claim 1, Haymond does not specifically disclose one or more scannable codes disposed on the test card, the one or more unique scannable codes encoding assay-specific information and image-capture instructions, the assay-specific information identifying the negative test region, positive test region, and sample region, and the image-capture instructions comprise information relating to one or more of orientation, framing, exposure, white balance, or timing for capture of an image of the test card that is suitable for computer-implemented image analysis by a machine learning algorithm.
Further, as in claims 12 and 13, Haymond does not specifically disclose two or more unique scannable codes comprising a first and second code as in cl. 12 and comprising data pertaining to the test card and data for instructing the processor as in cl. 13. With regard to claim 14, as best understood, Haymond does not specifically disclose that the data for instructing the processor to capture the image of the test card comprises one or more of the data recited therein. With regards to claims 15-17, Haymond does not specifically disclose the one or more unique scannable codes further comprise data pertaining to the test card, the one or more unique scannable codes is a QR code, and the one or more unique scannable codes are readable by a processor in communication with an image sensor.
Scherr discloses secure machine readable code-embedded diagnostic tests (abstract). Scherr discloses rapid diagnostic tests for quickly and accurately detecting biomarkers, pathogens, and the like, and wherein an applied QR code is configured to provide for straightforward image registration, orientation, and scaling (image registration, orientation and scaling constituting image-capture instructions comprising information relating to orientation and/or framing (seen herein equivocally as in “scaling”) for capture of an image as claimed, pars.[0015]; see also par.[0042]), and provides assay-specific information identifying the [claimed regions] as seen in par.[0016] in which the data encoded to the QR codes affords identification of the X-Y coordinates of the test line/test modules. Further, Scherr discloses that the QR codes afford the ability to assure that the image utilized for quantitative analysis of the test will be adequate, and the QR code further includes data to the test card such as in manufacturing information, test type, lot number, and the like, and affords the test results and embedded information payload therein to be uploaded to any electronic health record system or database while also maintaining a high level of security of the personal health results of the patient (pars.[0015,0016,0042], for example). From the above, Scherr provides in par.[0016] that the data encoded into the QR code maybe be used to identify X-Y coordinates of the test modules, which equivocally provides “assay-specific information identifying [regions as recited],” as such QR code pertains to the assay regions of the RDT (rapid diagnostic test), and Scherr further provides in par.[0015] that the QR code encodes image-capture instructions comprising information relating to one or more of orientation and scaling (disclosed equivocally in Scherr as “scaling”) for capture of an image that is suitable for computer-implemented image analysis by a machine learning algorithm as claimed.
It would have been obvious to one of ordinary skill in the art to modify Haymond to include one or more unique scannable codes comprising data for instructing a processor as in cls. 1 and 14-17 such as taught by Scherr in the analogous field of rapid diagnostic tests in order to provide a QR code that may be simply appended to the card and provides for effectively and automatically instructing the machine as in the processor/camera for straightforward image registration, orientation, and scaling that affects increased accuracy of the pertinent area of the test card that is assessed by the image analysis, and also providing a scannable code that affords security to the patient’s sensitive data as well as correlating and embedding information as to the card’s manufacture, lot number, etc. as in cls. 12&13 and test to develop a clear record and of which is uploadable to a database.
Further, as in cls. 12&13, while Scherr appears to provide a singular QR code providing the dual-functionality of both providing data for instructing the processor to capture an image and embedding data pertaining to the test card as in lot number, it would have been an obvious engineering design choice to provide separate QR codes for each of the two functionalities. This is seen as an obvious engineering design choice of a rearrangement or duplication of parts in which providing individual QR codes for the two discussed functionalities in Scherr is not seen to have patentable significance unless a new and unexpected result is produced. See also MPEP 2144 VI, B, C, for example.
With regards to claims 18-20, the recitations are drawn to process recitations not afforded patentable weight in a device claim (i.e. in claim 18 “the computer-implemented image analysis” is both not a positively recited element of the claims and is drawn to process recitations). As discussed above, the combination of Haymond and Scherr provide the one or more unique scannable codes comprising data for instructing as claimed, and the claims are both drawn to a device wherein such process recitations are not afforded patentable weight and the language itself to the “computer-implemented image analysis” is merely inferentially introduced in relation to a functionality of the data.
Claim(s) 1, 6, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond (USPN 3,853,468) in view of Barstis et al. (US 2016/0370389), hereafter Barstis.
Haymond discloses a method and apparatus for clinical testing of biological fluids (abstract). Haymond discloses a test card comprising a negative control test region 13 for receiving a negative test control fluid sample, a positive control test region 11 for receiving a positive control fluid sample, and a test sample region 12 for receiving a test fluid sample (lines 45-67, col. 2; line 35, col. 3 – line 20, col. 4, figures, for example). Haymond further discloses that comparison between the test area(s) and the positive and negative control areas can be done by visual inspection or by machine, and the top of the test card may bear a space to identify the test and a space to mark the date the test is made (lines 64-67, col. 4; lines 12-16, col. 5). With regard to claim 6, the recitation is drawn to an intended use recitation not afforded patentable weight.
With regard to claim 1, Haymond does not specifically disclose one or more scannable codes comprising data for instructing a processor to capture an image of the test card that is suitable for computer-implemented image analysis. Further, as in claims 12 and 13, as best understood herein, Haymond does not specifically disclose two or more unique scannable codes comprising a first and second code as in cl. 12 and comprising data pertaining to the test card and data for instructing the processor as in cl. 13. With regard to claim 14, as best understood, Haymond does not specifically disclose that the data for instructing the processor to capture the image of the test card comprises one or more of the data recited therein. With regards to claims 15-17, Haymond does not specifically disclose the one or more unique scannable codes further comprise data pertaining to the test card, the one or more unique scannable codes is a QR code, and the one or more unique scannable codes are readable by a processor in communication with an image sensor.
Barstis discloses a paper analytical device (PAD) including one or more assay regions and method for detection of low quality pharmaceutical or dietary supplement (abstract). Barstis discloses that each PAD is imprinted with a two-dimensional bar code such as a QR code that contains the type and serial number of the PAD, and in which a key task of the image analysis software is the perspective correction or transformation of distorted images in which the QR code may be provided with finder marks/fiducial marks thereon. Barstis further discloses that the image software identifies the QR code region and separates the image of the PAD’s assay regions from background present in the picture, scales, and rotates, and performs geometrical transformations (QR code encoded with image-capture instructions as claimed, providing data relating to orientation, framing for capture of an image of the test card that is suitable for computer-implemented image analysis by a machine learning algorithm, and as seen above with the perspective correction and transformation of distorted images) of the captured PAD images based on the QR code and fiducials, another scannable code, and which affords the assay-specific information as claimed in that of the alignment of the PAD assay regions (pars.[0040,0062,0066-0068], figs., for example).
It would have been obvious to one of ordinary skill in the art to modify Haymond to include one or more unique scannable codes comprising data for instructing a processor as in cls. 1 and 14-17 such as taught by Barstis in the analogous field of paper analytical devices in order to provide a QR code that may simply imprinted to the card and provides for effectively and automatically instructing the machine as in the processor/camera for providing distortion correction and framing, scaling, and rotating the test card’s assay regions while separating the background in order to provide increased accuracy of the pertinent area of the test card by the image analysis software, and also providing a scannable code that affords correlating and embedding information as to the card’s manufacture, lot number, etc. as in cls. 12&13 and test to develop a clear record and of which is storable to a database.
Further, as in cls. 12&13, while Barstis appears to provide a singular QR code providing the dual-functionality of both providing data for instructing the processor to capture an image and embedding data pertaining to the test card as in lot number (i.e. type and serial number of the PAD), it would have been an obvious engineering design choice to provide separate QR codes for each of the two functionalities. This is seen as an obvious engineering design choice of a rearrangement or duplication of parts in which providing individual QR codes for the two discussed functionalities in Barstis is not seen to have patentable significance unless a new and unexpected result is produced. See also MPEP 2144 VI, B, C, for example.
With regards to claims 18-20, the recitations are drawn to process recitations not afforded patentable weight in a device claim. As discussed above, the combination of Haymond and Barstis provide the one or more unique scannable codes comprising data for instructing as claimed, and the claims are both drawn to a device wherein such process recitations are not afforded patentable weight and the language itself to the “computer-implemented image analysis” is merely inferentially introduced in relation to a functionality of the data.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Scherr as applied to claims 1, 6, and 12-20 above, and further in view of Moorman (USPN 5,820,826).
Haymond discloses a test sample region, a positive control test region comprising a positive reagent that causes various levels of agglutination of the positive control fluid sample, and discloses a negative control test region comprising fluid from a negative control source mixed with the same reagent, wherein Haymond discloses that the target antigen may be detected by utilizing tanned red cell-latex particle mixture sensitized with antibodies which agglutinate in the presence of the antigen, and also discloses that the reverse approach is likewise applicable wherein a tanned red cell-latex mixture sensitized with an antigen agglutinates in the presence of the antibodies (and as in cl. 3) (abstract; lines 45-56, col. 2; lines 58-67, col. 3).
Further, with respect to claim 4, Examiner asserts that the negative control fluid sample, positive control fluid sample, and the test fluid sample are not positively claimed elements of the test card and are drawn to prospective workpieces not afforded patentable weight (they are inferentially related by way of functionality of the individual regions providing for receiving such fluid samples).
Lastly, with respect to claim 5, the recitation is drawn to process recitations not afforded patentable weight in a device claim. As discussed below, modified Haymond/Scherr by way of Moorman provides to disclose the commensurately claimed elements of the device wherein such negative, positive, and test reagents are activatable by a blood sample received (and while not required, Haymond discloses such activation in the antigen-antibody interaction within the patient’s blood sample at each region) and such blood sample (nor its retrieval procedure), which is not a positively claimed element of the device and is drawn to an intended workpiece is not attributed patentable weight.
Haymond/Scherr does not specifically disclose that the negative control test region comprises a negative reagent that prevents agglutination as in claim 2.
Moorman discloses a diagnostic test strip (abstract). Moorman discloses that the diagnostic strip includes a negative control region 12, a test region 13, and a positive control region 14. Moorman discloses that the negative control is designed as a marker for the integrity of the test system and this region should never present a signal. Moorman discloses that if the analyte of interest is an antigen (detected by antibody-antigen reaction), the negative control may contain inactivated or non-immune immunoglobin or antibodies of the same species present in the test region. Moorman further discloses that inactivated forms of protein A, biotin-streptavidin/avidin complexes, and IgG as a non-immunoactive forms of antibodies may be utilized in the negative control, and further discloses that in analogous sense if the test is for detecting antibodies then the region contains reagent in inactive forms of the antigen (line 52, col. 7 – line 10, col. 8, figs., for example).
It would have been obvious to one of ordinary skill in the art to modify Haymond/Scherr to provide the negative control region with a negative reagent (i.e. inactive forms of the antigen) that prevents agglutination of the negative control sample such as suggested by Moorman in the analogous art of binding assay devices in which such a constitution to the negative control test region of Haymond/Scherr provides an obvious, alternative form thereto for a likewise desired purpose of achieving negative control that does not present a signal as likewise desired in Haymond and would have a reasonable expectation of success therein.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Barstis as applied to claims 1, 6, and 12-20 above, and further in view of Moorman (USPN 5,820,826).
Haymond discloses a test sample region, a positive control test region comprising a positive reagent that causes various levels of agglutination of the positive control fluid sample, and discloses a negative control test region comprising fluid from a negative control source mixed with the same reagent, wherein Haymond discloses that the target antigen may be detected by utilizing tanned red cell-latex particle mixture sensitized with antibodies which agglutinate in the presence of the antigen, and also discloses that the reverse approach is likewise applicable wherein a tanned red cell-latex mixture sensitized with an antigen agglutinates in the presence of the antibodies (and as in cl. 3) (abstract; lines 45-56, col. 2; lines 58-67, col. 3).
Further, with respect to claim 4, Examiner asserts that the negative control fluid sample, positive control fluid sample, and the test fluid sample are not positively claimed elements of the test card and are drawn to prospective workpieces not afforded patentable weight (they are inferentially related by way of functionality of the individual regions providing for receiving such fluid samples).
Lastly, with respect to claim 5, the recitation is drawn to process recitations not afforded patentable weight in a device claim. As discussed below, modified Haymond/Scherr by way of Moorman provides to disclose the commensurately claimed elements of the device wherein such negative, positive, and test reagents are activatable by a blood sample received (and while not required, Haymond discloses such activation in the antigen-antibody interaction within the patient’s blood sample at each region) and such blood sample (nor its retrieval procedure), which is not a positively claimed element of the device and is drawn to an intended workpiece is not attributed patentable weight.
Haymond/Barstis does not specifically disclose that the negative control test region comprises a negative reagent that prevents agglutination as in claim 2.
Moorman has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Haymond/Barstis to provide the negative control region with a negative reagent (i.e. inactive forms of the antigen) that prevents agglutination of the negative control sample such as suggested by Moorman in the analogous art of binding assay devices in which such a constitution to the negative control test region of Haymond/Barstis provides an obvious, alternative form thereto for a likewise desired purpose of achieving negative control that does not present a signal as likewise desired in Haymond and would have a reasonable expectation of success therein.
Claim(s) 7, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Scherr as applied to claims 1, 6, and 12-20 above, and further in view of Patel et al. (WO 2014/015194), hereafter Patel.
Haymon/Scherr does not specifically disclose that the negative control test region comprises a negative reagent that comprises a nanobody configured to bind red blood cells and cause non-antigen specific agglutination of the red blood cells.
Patel discloses a method for detecting present of an antibody in a biological sample in which the negative control test region comprises a negative reagent that comprises a nanobody configured to bind red blood cells and cause non-antigen specific agglutination of the red blood cells(pars.[0121-0123,0128-0130], for example)
It would have been obvious to one of ordinary skill in the art to modify Haymon/Scherr so as to utilize a reagent that comprises a nanobody configured to bind red blood cells and cause non-antigen specific agglutination of the red blood cells such as suggested by Patel in the analogous art of agglutination assays in which such a reagent and approach represents an obvious alternative manner of accomplishing a similarly desired negative control test region as in Haymond and would have a reasonable expectation of success therein.
Claim(s) 7, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Barstis as applied to claims 1, 6, and 12-20 above, and further in view of Patel et al. (WO 2014/015194), hereafter Patel.
Haymon/Scherr does not specifically disclose that the negative control test region comprises a negative reagent that comprises a nanobody configured to bind red blood cells and cause non-antigen specific agglutination of the red blood cells.
Patel has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Haymon/Barstis so as to utilize a reagent that comprises a nanobody configured to bind red blood cells and cause non-antigen specific agglutination of the red blood cells such as suggested by Patel in the analogous art of agglutination assays in which such a reagent and approach represents an obvious alternative manner of accomplishing a similarly desired negative control test region as in Haymond and would have a reasonable expectation of success therein.
Claim(s) 8-11, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Scherr as applied to claims 1, 6, and 12-20 above, and further in view of Townsend et al. (“A haemagglutination test for rapid detection of antibodies to SARS-CoV-2, Nature Communications, published March 29th, 2021; (2021) 12:1951; https://doi.org/10.1038/s41467-021-22045-y), hereafter Townsend.
Haymond/Scherr does not specifically disclose a positive control test region comprising a positive reagent as in cl. 8, a test sample region comprising a test reagent as in cls. 9 and 10, and a test fluid sample with an antigen derived from SARS-CoV-2 virus as in cls. 10 and 11.
Townsend discloses red cell agglutination tests as simple, fast, and effective tests for point-of-care. Townsend discloses a quantitative haemagglutination test (HAT) for the detection of antibodies to the receptor binding domain of the SARS-CoV-2 spike protein (abstract). Townsend discloses in order to link the SARS-CoV-2 RBD to red cells, the single domain antibody/nanobody IH4 (a nanobody as in cl. 9, and as in cl. 10) specific for a conserved epitope on GPA was selected and detection of antibodies to the SARS-CoV-2 is achieved by linking the RBD of the SARS-CoV-2 spike protein to IH4 via s short (GSG)2 linker to produce the fusion protein IH4-RBD-6H test reagent (column 1, page 2). Townsend further discloses a positive control utilized in HAT as a point-of-care test as CR3022 an anti-RBD monoclonal antibody added as in cls. 8 (Fig. 6, page 8; “HAT protocol” steps col. 2, page 9). Townsend further discloses a negative control reagent of PBS was added to the negative control wells (col. 2, page 5, fig.4, for example). Townsend further discloses that the COVID-19 pandemic has had a particularly grueling influence on the world economy and there is a need for affordable serological tests for detection of immune responses to SARS-CoV-2, wherein antibody tests are both not widely available to low and middle income countries and lateral flow assays are expensive and have failed to deliver in terms of performance metrics, whereas HAT provides for low cost of production, better performance than most lateral flow devices and versatility (“Discussion” col. 2, page 6 – col. 1, page 7, for example).
It would have been obvious to one of ordinary skill in the art to modify Haymond/Scherr to utilize a positive control test region comprising a positive reagent as in cl. 8, a test sample region comprising a test reagent as in cls. 9 and 10, and a test fluid sample with an antigen derived from SARS-CoV-2 virus as in cls. 10 and 11 such as taught and suggested by Townsend in the analogous field of agglutination assays for point-of-care diagnostics in which provides an affordable, versatile and sensitively-performing platform in which such reagents afford an average 90% sensitivity and 99% specificity in detection of immune response to SARS-CoV-2 that is a highly prevalent virus of clinical significance to be desirably monitored and tested for by the world’s population at-large as one countermeasure to minimizing its spread.
Claim(s) 8-11, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Barstis as applied to claims 1, 6, and 12-20 above, and further in view of Townsend et al. (“A haemagglutination test for rapid detection of antibodies to SARS-CoV-2, Nature Communications, published March 29th, 2021; (2021) 12:1951; https://doi.org/10.1038/s41467-021-22045-y), hereafter Townsend.
Haymond/Bartris does not specifically disclose a positive control test region comprising a positive reagent as in cl. 8, a test sample region comprising a test reagent as in cls. 9 and 10, and a test fluid sample with an antigen derived from SARS-CoV-2 virus as in cls. 10 and 11.
Townsend has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Haymond/Bartris to utilize a positive control test region comprising a positive reagent as in cl. 8, a test sample region comprising a test reagent as in cls. 9 and 10, and a test fluid sample with an antigen derived from SARS-CoV-2 virus as in cls. 10 and 11 such as taught and suggested by Townsend in the analogous field of agglutination assays for point-of-care diagnostics in which provides an affordable, versatile and sensitively-performing platform in which such reagents afford an average 90% sensitivity and 99% specificity in detection of immune response to SARS-CoV-2 that is a highly prevalent virus of clinical significance to be desirably monitored and tested for by the world’s population at-large as one countermeasure to minimizing its spread.
Claim(s) 8-10, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Scherr as applied to claims 1, 6, and 12-20 above, and further in view of Kruse et al. (A Hemagglutination-based semiquantitative test for point-of-care determination of SARS-COV-2 antibody levels), hereafter Kruse.
Haymond/Scherr does not specifically disclose a positive control test region comprising a positive reagent as in cl. 8, a test sample region comprising a test reagent as in cls. 9 and 10, and a test fluid sample with an antigen derived from SARS-CoV-2 virus as in cls. 10 and 11.
Kuse discloses a hemagglutination-based semiquantitative test for point-of-care determination of SARS-COV-2 antibody levels in which a card comprises a nanobody (and given as a dromedary-derived antibody by way of Applicant’s equating such in their disclosure) targeting human glycophorin A (GYPA) and the RBD of SARS-CoV-2 to both the test and control regions of the card. Kuse further discloses the addition of blood containing COVID-19 antibodies to facilitate cross-linking of RBCs with the fusion protein (abstract, page 3, fig. 1 description, for example).
It would have been obvious to one of ordinary skill in the art to modify Haymond/Scherr to utilize a nanobody reagent as in claims 7-9 to the negative control test region, positive control test region, and test sample region such as suggested by Kruse in the analogous art of agglutination assays/cards in which such a nanobody reagent provides semi-quantitative information and high levels of specificity for SARS-CoV-2 antibodies and in which while Kuse provides application of the nanobody reagent to the test and control region, it would have been obvious to one of ordinary skill in the art to provide such nanobody reagent to a negative control test region and positive control test region so as to conform to the formatting of the agglutination card provided in Haymond.
Claim(s) 8-11, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haymond in view of Barstis as applied to claims 1, 6, and 12-20 above, and further in view of Kruse et al. (A Hemagglutination-based semiquantitative test for point-of-care determination of SARS-COV-2 antibody levels), hereafter Kruse.
Haymond/Bartris does not specifically disclose a positive control test region comprising a positive reagent as in cl. 8, a test sample region comprising a test reagent as in cls. 9 and 10, and a test fluid sample with an antigen derived from SARS-CoV-2 virus as in cls. 10 and 11.
Kuse has been discussed above.
It would have been obvious to one of ordinary skill in the art to modify Haymond/Barstis to utilize a nanobody reagent as in claims 7-9 to the negative control test region, positive control test region, and test sample region such as suggested by Kruse in the analogous art of agglutination assays/cards in which such a nanobody reagent provides semi-quantitative information and high levels of specificity for SARS-CoV-2 antibodies and in which while Kuse provides application of the nanobody reagent to the test and control region, it would have been obvious to one of ordinary skill in the art to provide such nanobody reagent to a negative control test region and positive control test region so as to conform to the formatting of the agglutination card provided in Haymond.
Response to Arguments
Applicant's arguments filed February 12th, 2026 have been fully considered but they are not persuasive.
With regards to claims 7-9 rejected under 35 USC 112 a/1st paragraph, Applicant traverses the rejection.
Applicant asserts that the Office Action asserts that the application defines a nanobody as a “dromedary-derived antibody.”
Examiner asserts that no such definition is set forth, as the rejection itself is drawn to inadequate disclosure of a nanobody (and correspondingly under 35 USC 112 b/2nd wherein the metes and bounds of such term and the structural constituency are indefinitely defined in the specification).
The Office Action sets forth, in part, “[e]xaminer notes that the disclosure references “dromedary-derived antibody” and provides in parenthesis an inference of equating such to a “nanobody,” however this is both inadequate and appears incongruent as a nanobody and an antibody are different types of elements.”
Applicant further asserts that the application defines nanobodies as “bispecific proteins that contain a dromedary-derived antibody” at par.[0064].
Examiner asserts that par.[0064] does not provide for a particular definition to the claimed “nanobodies” for their recited functionalities.
The mere presence of the word “nanobody” within parenthesis thereafter does not provide adequate disclosure as to provides basis for the recitations of claims 7-9 to the “nanobodies” configured for their particular, respective functionalities therein.
Further, as discussed above, the disclosure in par.[0064] is both is also inconguent as a nanobody and an antibody are different types of elements, and Applicant has not offered any discussion or clarification to this end.
The term “nanobody” for its recited functionality is also not a recognized term of the art.
Additionally, and not withstanding that “nanobody” itself is not adequately described and disclosed herein, bispecific proteins themselves are drawn to individually-engineered proteins wherein the constitution that they contain a dromedary-derived antibody does not suffice for particular, engineered bispecific proteins.
Lastly, presence of the discussion to “bispecific proteins that contain a dromedary-derived antibody” provides a species-type disclosure that does not afford support to the genus-type term “nanobody” utilized throughout the claims for their particular functionalities.
Examiner lastly asserts that Applicant has not addressed the fact that it appears Nanbody® and Nanobodies® are trademarks owned by Ablynx N.V., which is not acknowledged/refuted, nor does Applicant provide their own particular support thereto.
With regards to claims 18-20 rejected under 35 USC 112a/1st, Applicant traverses the rejection.
Applicant asserts that the application specifies that the machine learning algorithm may be executed by a neural network and more specifically may be executed by a deep learning convolutional neural network.
Applicant further asserts that the training is disclosed in figure 5.
Examiner asserts that the general, categorical discussion of the execution of the machine learning algorithm by neural network, such as in a deep learning convolutional neural network is drawn to a highly generalized offering of known artificial intelligence structures in image analysis, and the discussion to the “training” in fig. 5 is also provided at a high level of generality that does not adequately provide for the machine learning algorithm as claimed.
As discussed above, general discussion to a CNN and generalized training protocol remains to be absent to the actual, particular machine learning algorithm(s) itself.
The specification is devoid of particular discussion to one or more particularly developed machine learning algorithms.
As discussed above, Examiner notes that there is a singular exemplification of “YOLOV3” that is a convolutional neural network but the disclosure is absent any particulars thereof to adequately describe and define such beyond the high level, known object finding algorithm and is without particulars thereto in the sought, claimed applications herein.
With regards to the “Claim Interpretation” under 35 USC 112 F, Applicant asserts that the claims have been amended to obviate the interpretation.
Examiner asserts that usage of “capable of” in lieu of “configured to” is drawn to synonymous language that sets forth a functionality to the nanobody, wherein “nanobody” remains to be drawn to a generic placeholder followed by functional language without sufficient structure to perform the recited function.
With regards to claims 7-9 rejected under 35 USC 112 b/2nd, Applicant asserts that the claims have been amended to obviate the rejection and asserts that “nanobody” refers to a bispecific protein that contains a dromedary-derived antibody.
Examiner maintains that the metes and bounds of the constituent structure(s) and equivalents thereof that are afforded to “nanobody” are indefinitely defined herein and by the specification.
Examiner further reasserts those remarks as presented above with respect to the rejection of the claims under 35 USC 112a/1st as they are similarly pertinent here.
Lastly, Examiner asserts that discussion to “bispecific protein that contains a dromedary-derived antibody” is drawn to a species-type discussion that does not afford basis or clear metes and bounds to the broader, genus-type recitation of “nanobody.”
Examiner notes that rejection of claims 6-11 under 35 USC 112 b/2nd has been removed in the view of the amendments to the claims.
Rejection of claims 7-9 in both instances (the numbering is corrected in the second instance of the rejection from 6-9 to 7-9 due to an inadvertent error) remains for the reasons discussed above in the body of the action, and wherein the remarks are without further, particular traversal and remarks thereto.
With regards to claims 1, 6, and 12-20 rejected under 35 USC 103 as being unpatentable over Haymond in view of Scherr, Applicant traverses the rejection.
Applicant asserts that Scherr does not cure the deficiencies of Haymond.
Applicant asserts that despite Scherr discussing scannable QR codes on a test card, Scherr treats the QR code as a subject of image analysis rather than as a source of encoded instructions that control image capture of the test card itself, as recited by currently amended claim 1.
Initially, Examiner asserts that Applicant’s arguments are not persuasive as they are not commensurate in scope with the claims.
Applicant asserts “…rather than as a source of encoded instructions that control image capture of the card itself, as recited by currently amended claim 1,” however, claim 1 does not necessitate any such control of image capture of the test card itself.
Examiner maintains that Scherr commensurately provides one or more unique scannable codes as recited herein, and is drawn to analogous art to that of Haymond providing
The recitation is drawn to information and the correlation of that information to “orientation, farming, etc.…” is codified in a highly broad fashion by way of “relating to.”
The claim recitation herein is drawn to “information relating to…” and does not provide any control of image capture therewith. To this end, it is also seen that the claims are absent positive provision to a reader/processor that scans the code(s) and a communicatively coupled and configured imager.
Scherr provides in par.[0016] that the data encoded into the QR code maybe be used to identify X-Y coordinates of the test modules, which equivocally provides “assay-specific information identifying [regions as recited],” as such QR code pertains to the assay regions of the RDT (rapid diagnostic test).
Scherr further provides in par.[0015] that the QR code encodes image-capture instructions comprising information relating to one or more of orientation and scaling (disclosed equivocally in Scherr as “scaling”) for capture of an image as claimed.
The codes of Scherr equivocally provide image-capture instructions as in “information relating to…” that is fully capable of being utilized for prospective capture of an image, and that is suitable for computer-implemented image analysis by a machine learning algorithm, in which such discussion is drawn to prospective intended use of the code(s) itself that is not positively necessitated by the claim.
Further, though not required by the claim, Scherr discloses in par.[0015] (about halfway down) that successful recognition of a QR code is used as a trigger for a camera, and upon recognition of the code, an image of the QR code control line and test line or test modules are captured in a single image.
By this, Scherr equivocally provides one or more unique scannable codes disposed on the test card and comprising assay-specific information comprising information, and image-capture instructions comprising information relating to those elements as recited in claim 1.
By this, it is maintained that Scherr provides one or more unique scannable codes encoding assay-specific information and image-capture instructions in as much as claimed and recited herein.
By this, claims 1, 6, and 12-20 are maintained rejected under 35 USC 103 as being unpatentable over Haymond in view of Scherr.
With regards to claims 1, 6, and 12-20 rejected under 35 USC 103 as being unpatentable over Haymond in view Barstis, Applicant traverses the rejection.
Applicant asserts that Barstis fails to remedy the deficiencies of Haymond and Scherr.
Initially, Examiner assert that Scherr and Barstis are not utilized together in the rejection, but are provided separately and in parallel with Haymond over the claims as discussed above in the body of the action.
Applicant asserts that Barstis does not teach or suggest one or more unique scannable codes disposed on the test card, the one or more unique scannable codes encoding assay-specific information and image-capture instructions as recited in claim 1.
Examiner asserts that for likewise reasons as discussed above, Barstis is maintained as providing one or more unique scannable codes encoding assay-specific information and image-capture instructions as recited in claim 1.
The QR code in Barstis is encoded with image-capture instructions comprising information relating to orientation and framing as clearly seen by the image software identification of the QR code affording the image of the PAD to be separated from background so as to orient and scale the desired area(s) (par.[0040,0066]).
The QR code of Barstis equivocally provide image-capture instructions as in “information relating to…” that is fully capable of being utilized for prospective capture of an image, and that is suitable for computer-implemented image analysis by a machine learning algorithm, in which such discussion is drawn to prospective intended use of the code(s) itself that is not positively necessitated by the claim.
Further, the fiducial marker scannable codes of Barstis afford the assay-specific information in which such fiducial markers comprise information identifying the regions, as seen in par.[0066] in which such information from the fiducial markers informs alignment of the PAD assay regions.
By this, claims 1, 6, and 12-20 are maintained rejected under 35 USC 103 as being unpatentable over Haymond in view of Barstis.
With regard to the remaining dependent claims, Applicant asserts that the rejections are moot given their dependence on the above claim 1.
Examiner asserts as there are no such deficiencies in either combination of Haymond and Scherr, Haymond and Barstis, the remaining dependent claims are maintained rejected over the cited art of record and for the reasons discussed above in the body of the action.
Lastly, in view of the amendments made to claim 14, a new grounds of rejection has been provided under 35 USC 112 b/2nd for the reasons discussed above in the body of the action. Further, to this end, the prior art of Haymond/Scherr, Haymond/Barstis is said to provide for such recitation of claim 14 as best understood herein, wherein Haymond/Scherr, Haymond/Barstis remain to provide one or more unique scannable codes with likewise “information relating to…” wherein the claimed “instructions…” are drawn information/data as likewise commensurately provided by the codes of the prior art combinations, and the claim does not necessitate any active integration and scanning so as to affect an operation of a processor/camera.
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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798
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