DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. This Office Action is in response to the amendment filed 29 January 2024, wherein claims 1-10 were canceled and claims 11-20 were added.
Claims 11-20 are under consideration.
Priority
3. Receipt is acknowledged of certified copies of papers required by 35 CFR 1.55. Should Applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CRF 41.154(b) and 41.202(e). The effective filing date for purposes of applying prior art is 25 July 2022.
Failure to provide a certified translation may result in no benefit being accorded for the non-English translation.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 20 February 2024 was filed after the mailing date of the Instant Application on 29 January 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
5. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
6. Claims 11, 13, 15, and 18 are objected to because of the following informalities:
Regarding claim 11,
In line 4, it is unclear if “(“Sample Deposition”)” is the name of the first area. If it is, it should be introduced as such.
In line 9, it is unclear if “(“Signal amplification”)” is the name of the third area. If it is, it should be introduced as such.
In line 9, a semicolon should be added before “and a fifth control area”.
In line 13, "antibodies to the Spike protein of the virus" appears to be part of the portion dedicated to the detection of SARS-CoV-2 viruses but it is unclear as the commas and phrases around it read as a list.
In line 19, “the coronavirus” should be “the SARS-CoV-2 virus”.
In line 19, “the” before “unwanted biological components” should be removed.
Regarding claim 13, “the drop of sample” should be “a drop of sample”.
Regarding claim 15, the unpaired quotation mark should be removed.
Regarding claim 18,
“starting” should be removed as it is redundant.
“cells intestinal” should read “intestinal cells”.
There should be a comma before “or a drop of whole blood”.
“directly” should be removed as it is redundant.
“for viral antigenic evaluation” should be inserted after “wherein” to read something like “wherein viral antigenic evaluation is done with a biological sample selected from the group consisting of…”.
Appropriate correction is required.
Claim Interpretation
7. Regarding “relief” in claim 13, Examiner is interpreting the term to be a sculpted pit/indentation in the device.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 11-20 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 11 recites the limitation:
"the lateral flow" in line 2.
“the biological sample” in line 3.
“the first reaction” in line 4.
“the molecule” in line 5.
“the signal amplification” in line 9.
"the portion dedicated to the detection of SARS-CoV-2 viruses" in line 12.
"the portion dedicated to the detection of the relative antibody production" in line 13.
There is insufficient antecedent basis for these limitations in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “a first reaction area”, “a fourth test area”, and “a fifth control area”, and the claim also recites “(“Conjugation pad”)”, “(“Test line”)”, and “(“Control Line”)”, respectively, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For example, the first reaction area does not necessarily need to comprise a conjugation reaction or a pad. Similarly, the fourth and fifth areas do not necessarily need to be a line. See lines 6 and 11. The scope of what is inside the parentheses and what it describes outside of them should be the same.
Similarly, claim 17 recites the broad recitation “the molecular probes” and a narrower statement of the range/limitation, “(i.e., ACE2 receptor…)”.
Regarding claim 11, lines 12 to 16, it is unclear if both portions are part of one device or if they are two different options and thus there are multiple structural interpretations. Examiner is interpreting this limitation to be two different options for the test line of the device.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “antibody production”, which can refer to any antibody, but then recites “antibodies against the nucleoproteins of the viral envelope” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See line 14.
Regarding claim 11, line 16, “two results visible” is unclear because it can be interpreted as one test line (either virus or antibody) and the control line, or both test lines.
The term “about” in claim 11, line 18, is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “About 200 nm – 1 μm” could indicate different ranges to different people.
Regarding claim 11, line 18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 12-20, which depend on claim 11, are similarly rejected for all the reasons stated supra.
Regarding claim 12, "being associated" is unclear because it can be interpreted as an app integrated into the device or the device being used with another machine entirely. Thus, there are multiple interpretations present. Examiner is interpreting this limitation to be a separate machine.
Regarding claim 12, "an application based on the analysis of photographs" is unclear because it could be interpreted as an app on a separate device or the intended use of an application of the device, thus there are multiple interpretations present. Examiner is interpreting this limitation to be an app on a separate device.
Regarding claims 13 and 15, "diluted with a 1:2 aqueous solution" is unclear if it is the sample:solution ratio or if that is the ratio between two different compounds in the solution, thus there are multiple interpretations present. Examiner is interpreting this to be the sample:solution ratio.
Claim 14 recites the limitation "the biological matrix used for virus evaluation" and "the biological matrix used for antibody evaluation". There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 16, the first part of the claim recites “wherein the test line area comprises…” and the second recites “and in the portion dedicated to the detection of relative antibody production, the presence of antibodies directed against the nucleoproteins of the viral envelope.” The test line of the relative antibody production should have the nucleoproteins themselves, not “the presence of antibodies”. It is unclear if this limitation is a typo or is supposed to define what is being detected. Examiner is interpreting this limitation to be what the test line of the antibody test strip is detecting.
Claim 17 recites the limitation "the main molecular probes". There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the surface". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, it is unclear what the “covalent bonds with the surface of the materials involved” is. It could be interpreted to be a covalent bond between the detection probe and the pad, a covalent bond between the capture probe and the pad, covalent bonds between the sample and either probe, or all of the above. Examiner is interpreting this limitation to be a covalent bond between the capture probe and the pad itself.
Regarding claim 18, "first respiratory tract" is unclear since there is only one respiratory tract and it appears to imply that there is multiple.
Regarding claims 19-20, "wherein it is based" is unclear because "it" is undefined, this could be interpreted to be the device, a specific area of the device, or something else entirely. Thus, there are multiple interpretations present. Examiner is interpreting “it” to be the device as a whole.
Regarding claims 19-20, “different degree” is unclear because there is no control and therefore it is unclear what the concentrations are being compared to.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen
(CN 111024954 A; 17 April 2020) (See IDS filed 20 February 2024) in view of Lee (15 October 2020, Biosensors and Bioelectronics, 171: 112715), Choi (2010, Biosensors and Bioelectronics, 25: 1999-2002), and Laderman (US 20230204581 A1; CON 03 March 2021), as evidenced by Koczula (2016, Essays in Biochemistry, 60: 111-120).
Regarding claims 11, 14, and 16, Chen teaches Figures 1-3:
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wherein Figure 2 shows a test strip for detecting COVID-19 antigens (Brief Description, ¶ 2), which would be for viral detection, and Figure 3 shows a test strip for detecting COVID-19 antibodies (Brief Description, ¶ 3). Figure 1 shows a device where both strips are inserted, allowing for rapid detection of both COVID-19 virus and antibodies (Page 3, ¶ 4 and page 4, ¶ 7).
Regarding the test strip for detecting COVID-19 antigens, Chen teaches sample pad 4 (Page 4,
¶ 8) and first binding pad 5 (Page 4, ¶ 8), which read on first area to receive the biological sample and a second area where the conjugation takes place, respectively. In this second area, pad 5 is coated with colloidal gold-labeled coronavirus NP monoclonal antibodies and colloidal gold-labeled rabbit IgG antibody (Page 4, ¶ 8). Chen further teaches that the first reaction pad 6 has a detection line 8 and a control line 9 (Page 4, ¶ 8), which read on the fourth test area and fifth control area, respectively. The detection line 8 is coated with coronavirus NP monoclonal antibodies (Page 4, ¶ 8). COVID-19 nucleoproteins are defined as nucleocapsid proteins (NP) (Page 6, ¶ 9).
Regarding the test strip for detecting COVID-19 antibodies, Chen teaches sample pad 11 (Page 4, ¶ 10) and second binding pad 12 (Page 4, ¶ 10), which read on first area to receive the biological sample and a second area where the conjugation takes place, respectively. In this second area, pad 12 is coated with colloidal gold-labeled coronavirus NP and S proteins (Page 4, ¶ 10). Chen further teaches that the second reaction pad 13 has two detection lines 15 and 16, to detect coronavirus NP and S proteins, respectively, and a control line 17 (Page 4, ¶ 10). The detection line 15 is coated with anti-human IgM antibodies and detection line 16 is coated with anti-human IgG antibodies, both of which are specific for COVID-19 (Page 5, ¶ 1 and ¶ 7). When COVID-19 antibodies against the NP or S proteins are present, they will conjugate to the gold-labeled coronavirus NP and S proteins on pad 12. Once this complex reaches the test lines 15 and 16, the anti-human IgM and IgG antibodies will bind to the antibodies against the NP and S protein. Therefore, when the test is positive, the antibodies against the COVID-19 NPs will be present on the test line.
For both test strips, Chen further teaches judging the sample according to the color development of the test lines and the quality control lines (Page 9, ¶ 1). In summary, Chen teaches a rapid test device with two different test strips to detect both SARS-CoV-2 virus and antibodies with a first sample deposition area; a first reaction pad with nucleocapsid proteins for antibody detection; a test line and control line, wherein the test strip for the antibody detects SARS-CoV-2 antibodies directed against the nucleoproteins; and reading the test results by two results visible by a colored strip.
Chen does not teach using ACE2 receptor molecules for the second area of the test strip for detecting COVID-19 antigens, a signal amplification area with the addition of gold nanoparticles, coating the test line of the COVID-19 antigen test strip with spike protein, or the filter to get rid of unwanted biological components.
Regarding the ACE2 receptor molecules and spike protein antibodies for the conjugation and detection of the viral particles, respectively, Lee teaches the reverse: using ACE2 as the capture probe and a SARS-CoV-2 S1 antibody as the conjugate (Figure 1b; Figure 4a, pictured below):
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One of ordinary skill would know that all that the system requires to work is two binders of the S1 protein that do not interfere with each other. Since ACE2 capture receptor and detection antibody used here are functional in the lateral flow assay together, they are known not to interfere with one another.
Therefore, one of ordinary skill in the art would be able to switch their order to yield a predictably functional assay and it would have been obvious before the filing date to take the device of Chen and further use ACE2 as the detection probe and the Spike protein antibody as the capture probe for the detection of SARS-CoV-2 viruses. It would further be obvious to label the ACE2 receptor with colloidal gold, as discussed in Chen. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding the signal amplification area, Choi teaches two conjugate pads (Figure 1) for signal amplification in lateral flow assays (Abstract):
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wherein “The 1st AuNP conjugate was allowed to be immobilized with an antibody against an analyte for the purpose of the sandwich assay contained in a typical LFA system. The 2nd AuNP conjugate was designed to bind only with the 1st AuNP conjugate with a higher size. The two conjugates were positioned at different sites so as not to be mixed before the sandwich assay (Fig. 1). Using this strategy, we could achieve a high-sensitivity one-step LFA method for the analysis of troponin I as a model analyte.” (Introduction, ¶ 3) and “The 2nd AuNP conjugate was added to a conventional AuNP-based LFA system and was designed to specifically bind with the 1st AuNP conjugate. The LFA method developed in this study is useful in rapid analysis of an antigen lower than 1 ng/mL.” (Conclusions). In summary, Choi teaches a signal amplification area that uses two size-based gold nanoparticles that can be applied to different antigens and LFA systems.
Therefore, it would have been obvious to one of ordinary skill before the time of filing to take the device made obvious by Chen and Lee and further include Choi’s gold nanoparticle-based amplification area in order to increase the sensitivity of the test. Combining Choi’s gold nanoparticle-based amplification area with Lee’s detection and capture probes will result in a gold nanoparticle-linked ACE2 receptor. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding the filter, Laderman teaches a lateral flow assay for SARS-CoV-2 (Abstract, Figure 1). Additionally, Laderman teaches “In one embodiment, the sample pad comprises a porous material. The porous material comprises a matrix selected from […] nitrocellulose…” (¶ [0012]) and “In another embodiment, the sample is blood. In the embodiments where the sample is blood, the porous material of the sample [pad] can also act as a filter to filter out (e.g., retain) red blood cells and/or white blood cells, but allow the serum or plasma proceed through the mobile phase.” (¶ [0105]). Laderman does not a specific pore size. However, Koczula teaches “A range of nitrocellulose pore sizes are available, from 0.05 to 12 μm.” (Membrane).
Therefore, it would have been obvious to one of ordinary skill before the filing date to take the device made obvious by Chen, Lee, and Choi and further make the sample pad out of nitrocellulose in order to filter out the unwanted biological components. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Furthermore, the pore size of the filter is a result-effective variable and obvious to optimize. The size of the pores determines the clarity of the test sample moving through the test strips, and thus the efficacy of the assays. Excess contaminant may interfere with the reactions due to non-specific binding. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 12, Lee teaches “After 20 min, the strips were captured by a smartphone, and their peak intensities were analyzed.” (Figure 4a caption).
Regarding claims 13 and 15, Laderman teaches using nitrocellulose for the sample pad, as discussed supra. Chen further teaches sample hole 2 (Page 3, ¶ 9). This hole shape would predictably favor a spherical formation of the sample drop, as it would keep the sample contained. As for the 1:2 sample to solution ratio, Lee teaches suspending nasopharyngeal swabs in universal transport media (UTM), then further diluting the UTM samples with running buffer in a 1:1 ratio (Page 5, ¶ 1). While none of these references teach the 1:2 ratio directly, the dilution of samples is a result-effective variable. Too dilute samples could result in a false negative and samples that are too concentrated may overwhelm the test and cause non-specific binding, or false positives. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result-effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 17, Laderman teaches “In some embodiments, the analyte binding agent is immobilized to the test line through covalent or ionic means by techniques known by those skilled in the art.” (¶ [0112]) and “Saliva/oral fluid samples contain a high concentration of interfering substances that can contribute to non-specific binding. Early development prototype sample pads exhibited significant levels of NSB when run with normal pooled saliva with untreated sample pads. High concentrations of phosphate buffered saline (PBS) can help neutralize the causes of non-specific interactions.” (¶ [0202]). Lee also teaches “To avoid non-specific interaction between capture probes in test lines and detection probes, the nitrocellulose membrane was adequately treated with blocking solution. (3.3. Sensitivity and specificity of ACE2-based LFIA for SARS-CoV-2 S1).
Regarding claim 18, Chen teaches “The test sample of the present application is blood, which avoids the problem that the nucleic acid test collects upper respiratory tract samples and exposes the medical staff to a high risk.” (Page 9, ¶ 3) and “The blood includes human serum, plasma and whole blood samples.” (Page 9, ¶ 4).
Regarding claims 19-20, as discussed supra, Lee teaches using nasopharyngeal swabs as the sample, which would predictably contain nasal mucus as they are taken by inserting a swab into the nose (Figure 6a). Furthermore, Chen teaches “The colloidal gold immunochromatographic device of the present invention is used to detect the novel coronavirus COVID-19 at different concentrations.” (Page 9, ¶ 7). Therefore, the device made obvious by Chen, Lee, Choi, and Laderman would predictably work with a varying concentration of virus in the sample, as the sample can be diluted as needed. In order to determine whether the sample contains SARS-CoV-2 virus or antibodies, the positive results would have to be based on the different degree of concentrations of virus/antibodies in the samples as compared to a control. This is done through comparison of the control vs. test lines.
Conclusion
13. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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