DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the claims
The amendment filed 10/16/25 is acknowledged and has been entered. Claims 1-2, 4, 8-9 and 14-16 have been amended. Claims 6-7, 12 and 17-20 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 1-5, 8-11 and 13-16 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
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 1-5, 8-11 and 13-16 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.
Regarding Claims 1 and 10, the claims recite the following genera: “visualization particles”; “an analyte agglutination reagent”, “calibrator” and “fusion protein”. “” The claimed groups of molecules are broad and encompass diverse structures and biological functions. An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). See MPEP 2163.
In the instant case, the claim broadly encompasses the genus of “visualization particles” and the specification states “the term ‘visualization particle’ refers to any cell or particle that may be agglutinated and detected macroscopically or microscopically. ‘Visualization particles’ include, without limitation, erythrocytes, other cells, and microspheres” (paragraph 079]) and discloses the following examples: “the analyte may be a viral particle and the visualization particle is clustered using an agglutination reagent that is selective for the viral particle. See Figure 1, panel A. Alternatively, the analyte may be an antibody and the visualization particle may be clustered using an agglutination reagent that is selective for the antibody. See Figure 1, panel B. This agglutination is referred to herein as an agglutination binding assay (or hemagglutination assay "HA" assay where the visualization particle is a red blood cell)” (paragraph [048]). Regarding the agglutinating particles, the specification states: “’Agglutinating particles’ may include, without limitation, agglutination reagents, calibration particles, viral particles, foreign agents, antibodies, fragments of these, combinations of these, or fusion proteins of these (paragraph [040]). Regarding the “calibrator” the specification states: “[115] the calibration reagent includes a visualization binding moiety (VBM) and a calibrator binding moiety (CBM). The VBM binds to the visualization particle and the CBM binds to a calibrator particle to cause agglutination of the visualization particles. FIG. 2C illustrates a non-limiting example” (paragraph [115]). “To generate an internally controlled calibration for each analyte assay, at least one of the components of the calibration assay is used as a calibration standard (also referred to herein as the ‘calibrator’). The calibrator can be the calibration reagent or the calibration particle of a control assay. For example, where the calibration assay uses an antibody for the calibration particle, that antibody can be used as the calibrator. Similarly, if a viral particle is used as the calibration particle, the viral particle can be used as the calibrator” (paragraph [176]). The disclosure provides a single species within this genus: “The calibrator can be a strep tag antibody” (paragraph [253]). A skilled artisan cannot at once envisage the characteristic features of the genus claimed because the single species disclosed is not representative of the genus as a whole and Applicant has provided no structure or structure-to-function correlation, etc. such that possession of the genus of calibrators has been demonstrated. One skilled in the art at the time of filing would conclude that the inventors only had possession of a strep tagged antibody.
The disclosure teaches a method to identify antibodies for the SARS-CoV-2 virus, which includes the visualization particle of a GPA-directed nanobody “IH4”, which is strep tagged. The disclosure teaches the particle may be fused to one or both of two viral antigens - the receptor-binding domain of the Spike protein (Spike-RBC) of SARS- CoV-2 (NanoSpike) and the Nucleocapsid (NanoNuc) (paragraphs [252]-[253]). Thus, the breadth of the claims encompasses genera of agglutination reagents and visualization particles (cells, microspheres, etc.) and Applicant has not demonstrated possession of the genera claimed.
Claim 10 recites “a fusion protein with a visualization particle binding moiety and a calibration binding moiety.” The specification discloses the recombinant protein (fusion protein) may include a GPA-directed nanobody IH4. Regarding the nanobody of the claims, the disclosure provides only one species, the aforementioned IH4 nanobody, that may be fused to one or both of two viral antigens, including the receptor-binding domain of the Spike protein (Spike-RBC) of SARS- CoV-2 (NanoSpike) and the Nucleocapsid (NanoNuc), and may include a strep tag (paragraphs [252]-[253]). A skilled artisan cannot at once envisage the characteristic features of the genus of fusion proteins including a nanobody as claimed because the single species disclosed is not representative of the genus as a whole. One of ordinary skill would understand that Applicant had possession of this species, but did not demonstrate possession of the genus as a whole.
Since the instant specification does not disclose to the public the structures of the visualization particles, analyte agglutination reagent, calibrator, or fusion protein and provides no guidance as to the distinguishing features of each of the claimed genus of molecules. Additionally, the disclosure fails to provide a reasonable number of representative species within each genus. For all of these reasons, the claims do not meet the written description requirement of 35 USC § 112, first paragraph, and claims 1-11 are rejected.
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.
Claims1-5, 8-11 and 13-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is vague and indefinite in reciting “a first visualization particle binding moiety” because it is unclear if the first particle binding moiety is the agglutination reagent, if the agglutination reagent comprises the first particle binding moiety or if the applicant intends something else. Also, it is unclear what this binding moiety has to do with the target analyte. The claim also does not make clear all the relationships of the components. For example, the claim does not make clear what part the target analyte plays in the agglutination or how the first binding moiety binding to visualization particles has anything to do with a target analyte of interest. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims. The claims appear to be missing essential elements for a clear understand of what the applicant intends. Further, although the claim now recites utilizing a first visualization particle binding moiety the claim does not make clear how the binding moiety correlate with the target analyte. Please clarify.
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 1-5, 8-11 and 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea mental process without significantly more. The claim(s) recite(s) providing an agglutination pattern and a calibration pattern to generate an assay result and return the result. This judicial exception is not integrated into a practical application because there is no improvement within the technology; no particular treatment or prophylaxis; nor any of the other considerations under MPEP 2106.05 (a-c), e and h that impose meaningful limits upon the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps recited in addition to the judicial exception (the steps for the agglutination assay) were well-understood, routine and conventional before the filing date of the application.
The claims are directed to a process, which is one of the statutory categories of invention. (STEP 1: YES).
The claims, however, recite: “a calibration agglutination patter from at least one calibration mixture; and providing the analyte agglutination pattern and the calibration agglutination pattern to a computing device, the computing device configured to (i) generate an analyte assay result from the analyte agglutination pattern, wherein the analyte assay result corresponds to a concentration of the analyte in the biological sample, (ii) generate a calibration assay result from the calibration agglutination pattern, wherein the calibration assay result corresponds to a known concentration of the calibrator in the calibration assay, ….” (claim 1). These claims are analogous to the claims in Electric Power Group, LLC v. Alstom, S.A., directed to “collecting information, analyzing it, and displaying certain results of the collection and analysis”. Similarly a claim to collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC; and, a claim to identifying head shape and applying hair designs in In re Brown were all deemed patent ineligible subject matter. These claims were set forth as examples of claims that recite mental processes because the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind (See October Update to the 2019 PEG, at II. C. i.). Even claims that require a computer may still recite a mental process (see October Update at II. C. ii.). A claim that requires a generic computer recites a mental process. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted). Thus, the instant claims recite at least one judicial exception – a mental process. (STEP 2A, Prong One: YES).
In the instant case the computing device of the claims is “configured to (i) generate an analyte assay result from the analyte agglutination pattern … [and] (ii) generate a negative control assay result from the negative control agglutination pattern … [and] return an analyte concentration result”. The specification discloses this is achieved by “processing resources for executing instructions stored in non-transitory computer readable storage media. These instructions may be incorporated in an application stored locally to the computing device 306, an application accessible on a web browser, and so forth” (paragraph [205]). This reads upon software that is loaded or accessed by a generic computer/device and does not impose a “particular machine” limitation upon the method (See MPEP 2106.05(b)).
The steps recited in addition to the judicial exception are: incubating a test mixture with the reagents of the agglutination assay, incubating at least one calibration mixture, and capturing with aid of a light-sensing device the pattern that arises from both mixtures. These are pre-solution activities that amount to gathering data for use in the claimed process, e.g., a step of obtaining information. These are considered insignificant extra-solution activities (MPEP 2106.05(g)) that amount to those steps that must be performed for data gathering and outputting. This is analogous to the fact pattern in Mayo, where it was deemed all uses of the recited judicial exception require such data gathering or data output. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. In Mayo, claims were directed to determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis). Therefore, the additional steps of the claims do not integrate the judicial exception into a practical application. (Step 2A: Prong Two: NO).
The final analysis asks whether or not the steps recited in addition to the judicial exception amount to more than what was well-understood, routine and conventional activities previously known to the industry (MPEP 2106.05(d)) or, in other words, whether or not the additional steps, alone or in combination, provide an inventive concept.
In the instant case, the additional steps were known in the industry. Agglutination assays comprising incubating test mixtures of erythrocytes (“visualization particle” of the instant claims) with fusion protein, which provide the analyte binding moiety and act as the “agglutinating reagent”, were known prior to filing. Kruse et al. (Biochemical and Biophysical Res Comms., 553:165-171, Epub 2021 Mar 15) teaches a rapid point-of-care red blood cell (“RBC” a.k.a. erythrocyte) agglutination assay detecting antibodies against SARS-CoV-2. The assay comprises mixing two novel fusion proteins, RBD-2E8 and B6-CH1-RBD, with red blood cells. These fusion proteins were designed to bind red blood cells (RBCs) via a single-chain variable fragment (scFv), thereby displaying the receptor-binding domain (RBD) of SARS-CoV-2 spike protein on the surface of RBC (Abstract). The fusion proteins led to visible hemagglutination, indicating the presence of antibodies against SARS-CoV-2 RBD (see Kruse Fig. 1). The abstract concludes: “Given that our hemagglutination test uses methods routinely used in hospital clinical labs across the world for blood typing, we anticipate the test can be rapidly deployed at minimal cost. We anticipate our hemagglutination assay may find extensive use in low-resource settings for detecting SARS-CoV-2 antibodies” (emphasis added). Thus, the steps of the instant claims were routinely and widely used in the industry prior to the filing date of the application, and the additional steps do not amount to significantly more than the judicial exception itself. (STEP 2B: NO).
For all of these reasons, the Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an enumerated abstract idea judicial exception without significantly more.
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.
Claims 1, 8-11 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kruse et al., Biochemical and Biophysical Research Communications 553 (2021) 165-171) in view of Nguyen et al (Journal of Laboratory Automation 2016, Vol. 21(2), pages 287-296)
Kruse et al teaches a quantitative agglutination assay using a calibrator to detect a target analyte in a biological sample, with the “target analyte” being SARS-CoV-2 antibodies. The method comprises incubating blood draws (“biological sample” of the claim) to for a “test mixture” comprising erythrocytes (“visualization particles” of the claimed method) with an “analyte agglutination reagent”, which is Kruse’s mixture of RBD-2E8 and B6-CH1-RBD fusion proteins. These fusion proteins selectively bind to the erythrocytes (visualization particles) and the SARS-CoV-2 antibodies such that the analyte reagent agglutinates the visualization based on the concentration of the target analyte (e.g. Fig. 1, abstract, pgs 165-167). A fusion protein, RBD-2E8, was constructed, consisting of the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at the N-terminus, which is equivalent to the ABM disclosed in the current specification, connected via a linker to a single-chain variable fragment (scFv, consisting of VH and VL domains connected with a flexible linker) at the C-terminus targeting the H antigen on the surface of red blood cells (RBCs), which is equivalent to the visualization particle binding moiety recited in current claim 14. Kruse demonstrates that the analyte binding moiety (ABM referenced above) comprises an antigen particle, which is the antibody against SARS-CoV-2 RBD (fig 1) and “at least an antibody fragment”, which is the VH-VL moiety in Figure 1 (as recited in current claim 11).
Kruse et al teaches “one or more calibration mixtures comprising a calibrator agglutination reagent and a calibrator” wherein it states “a dilution series of RBD-2E8 was performed to test for optimal levels of protein to induce agglutination in presence of patient anti-RBD antibodies. A series of six 1:1 dilutions were performed from the ~100 mg/mL of RBD-2E8, B6-CH1-RBD (mammalian), and B6-CH1-RBD (bacterial) stocks” (at bullet 2.3). Figure 3 of the reference discloses these calibration results were captured using a light-sensing device (photography). The six dilutions also anticipate the “two calibration mixtures with different concentrations of the calibrator” (recited in claim 8).
Kruse teaches: “To read the assay, the plate was then tilted to allow the RBC pellet to dislodge; agglutination kept the pellet effectively in place. Figures 3 and 4 of the reference teach photography (“light-sensing device” of the claims) to observe “analyte agglutination patterns” (dislodge or pellet kept in place) from both test mixture and negative control mixture.
Kruse et al teach a fusion protein comprising a “C-terminus targeting the H antigen on the surface of red blood cells (RBCs)”. Since the H antigen is attached to oligosaccharide chains that project above the RBC surface and these chains are attached to proteins and lipids that lie in the RBC membrane, and glycophorins are sialoglycoprotein of the membrane of a red blood cell, then the Kruse et al discloses a “visualization particle binding moiety” VBM that binds a glycophorin protein on the erythrocytes (as recited in claim 14).
Kruse differs from the instant invention in failing to teach the use of and image-capturing device and a light sensing device and light sensing device and providing the agglutination pattern and the calibration patter to a computer.
Nguyen et al (Journal of Laboratory Automation 2016, Vol. 21(2), pages 287-296) teaches automated imaging and analysis of hemagglutination assays (same as in Kruse) by using computer vision and image processing and automatically generating results with the use of algorithms (e.g. abstract p 288, 290). Nguyen et al teaches the use of a charge-coupled device (CCD) camera and light sources for the image acquisition of the agglutination reactions in a sample and in dose response curves (calibration curve) (e.g. pgs 288-290). Nguyen et al teaches that this provides for a process that reduces the potential for human error in a manual reading method, crease a visual record of the results and reduces the labor hours for the reading of results (e.g. pg 288).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate automated imaging and analysis such as taught by Nguyen et al into the method of Kruse et al because Nguyen et al shows that it is known and conventional in the art and that this provides for a process that reduces the potential for human error in a manual reading method, crease a visual record of the results and reduces the labor hours for the reading of results. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating automated imaging and analysis such as taught by Nguyen et al into the method of Kruse et al.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kruse et al and Nguyen et al as applied to claims1, 8-11 and 13-16 and further in view of Redecke et al (Scientific Reports, Dec. 30, 2021, 11:24507).
See above for the teachings of Kruse et al and Nguyen et al.
Kruse et al and Nguyen et al differ from the instant invention in failing to teach the calibration assay is used to provide a calibration curve and the calibration curve is used to generate the calibrated test results.
Redecke et al teaches that it is known and conventional in the art to generate a calibration curve (standard curve) from a previous calibration curve to create a continuous standard curve which can improve the quantification approach (e.g. page 10).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate the creation of a calibration curve such as taught by Redecke et al from the calibration curve of Kruse et al because Redecke et al shows that it is known and conventional in the art that that this provides for a continuous standard curve which can improve the quantification approach. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the creation of a calibration curve such as taught by Redecke et al into the method of Kruse et al.
Response to Arguments
Applicant's arguments filed 10/16/25 have been fully considered but they are not persuasive.
112(a) Written Description:
Applicant argues that the claims have been amended to address the issues.
This argument is not found persuasive because the addition of the limitations “utilizing a first visualization particle binding moiety”, “utilizing an image-capture device” and the generation steps of the computer does nothing at all to provide support for the large genus of “visualization particles”, “analyte agglutination reagent” “calibrator” and “fusion protein”. The applicant has not provided specific arguments or showed evidence of the structures etc of the large genus of components. Therefore, the rejection has been maintained.
101 Rejection:
Applicant argues that currently amended claim 1 cannot be practically performed in the human mind and that “incubating a test mixture comprising a first potion of the biological sample, visualization particles and an analyte agglutination reagent, wherein the analyte agglutination reagent selectively agglutinates the visualization particles, utilizing a first visualization particle binding moiety, based on a concentration of the target analyte”, incubating at least one calibration mixture comprising a second portion of the biological sample, visualization particles….”.
This argument is not found persuasive because these limitation are considered to be additional elements which do not apply, rely on, or use the judicial exception/abstract idea in a manner that imposes a meaningful limit on the judicial exception/abstract idea. Also, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
Applicant’s remaining arguments have been considered but are moot in view of the new grounds of rejection.
Conclusion
No claims are allowed.
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.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678