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 .
Election/Restrictions
Applicant's election with traverse of (b) CV2 as the species of antigen and (o) Lymphoma as the species of cancer in the reply filed on 2025-11-22 is acknowledged. The traversal is on the grounds that an antigen species can be expressed by various cancers, a single cancer can express different antigen species, multiple species of antigens can be identified in a single species of cancer, and two types of tumors can be associated with multiple species of antigens. This is not found persuasive because the species of antigens and species of cancer impart an undue search burden due to their different field of search and undue examination burden. Where two or more species are claimed, a requirement for restriction to a single species may be proper if the species are mutually exclusive. Claims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first. This may also be expressed by saying that to require restriction between claims limited to species, the claims must not overlap in scope. See MPEP 806.04(f).
In the case that the applicant’s invention is a method for detecting cancer with multiple species of antigens, the claims should be amended to reflect that invention. Currently, claim 1 encompasses an invention with only one species of antigen indicating one species of cancer.
The applicant is reminded that upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141. See MPEP 809. Note: amended claim 1 is deemed a generic claim.
The requirement is still deemed proper and is therefore made FINAL.
Claim 5 and 7-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of antigens and nonelected species of cancers, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2025-11-22.
Claims 1-4, 6, and 17 are examined herein.
Information Disclosure Statement
The information disclosure statements filed 2025-09-17 and 2025-11-22 have been considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims the
benefit of Application Number 63/649,324 filed 2024-05-17. Based on the filing receipt, the
effective filing date of this application is May 17, 2024 which is the filing date of Application
Number 63/649,324 from which the benefit of priority is claimed.
The applicant’s specification recites, “This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/649,324, filed May 18, 2024, with the same title, the entire content of which is incorporated herein by reference” (see para. [0001]). However, the filing date of U.S. Provisional Patent Application Serial No. 63/649,324 is May 17, 2024. The applicant is required to amend the specification to recite the correct filing date of the provisional patent.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Dalmau (US 2023/0053910 A1, published 2023-02-23) as evidenced by Raoult, et al. (“The line blot: an immunoassay for monoclonal and other antibodies”, published 1989) in view of Koczula, et al. (“Lateral flow assays”, published 2016).
Dalmau teaches a method for detecting cancer in an animal, including at least one of a dog, a cat, a rabbit, or a ferret, as in claim 1 (see, e.g., detecting cancer – para. [0059]: “the carrier according to any of embodiments 5 to 6 for diagnosing a neurological autoimmune disease or a cancer”; animals including at least one of a dog or a cat – para. [0169]: “In a preferred embodiment, the sample is from an organism having a brain and producing autoantibodies, [..] more preferably a mammal from the group comprising [...] a dog, a cat”). Dalmau teaches the sample is a blood specimen, as in claim 1 (see, e.g., para. [0168]). Dalmau teaches binding the specimen to an intracellular neuronal protein immobilized on the test strip, as in claim 1 (see, e.g., para. [0056]-[0059] and para. [0189]). It is understood that amphiphysin, recoverin, Hu, Yo, Ri, and CV2 in embodiment 6 of Dalmau (described in para. [0058]) and SOX1 (see para. [0189] of Dalmau) are equivalents to intracellular neuronal proteins as evidenced by para. [0042] of the applicant’s specification. Dalmau teaches optically detecting a presence of at least one antigen-antibody binding complex using a predetermined threshold, as in claim 1 (see, e.g., para. [0189]: “The test strip may comprise a cut-off control band indicating the minimum staining that qualifies as an indication that an autoantibody has been detected”). It is understood that the staining of the cut-off control band is equivalent to optically detecting antigen-antibody binding complexes using a predetermined threshold.
Dalmau teaches providing an indication of positive for cancer when the presence of at least one antigen-antibody binding complex exceeds the predetermined threshold, as in claim 2 (see, e.g., para. [0189] and para. [0218]).
Dalmau teaches optically detecting the antigen-antibody binding complexes using a microscope, as in claim 4 (see, e.g., Dalmau claims 3 and 17-19).
Dalmau teaches detecting cancer in a mammalian animal, as in claim 17 (see, e.g., detecting cancer – para. [0059]: “the carrier according to any of embodiments 5 to 6 for diagnosing a neurological autoimmune disease or a cancer”; mammalian animal – para. [0169]: “In a preferred embodiment, the sample is from an organism having a brain and producing autoantibodies, [...] more preferably a mammal”). Dalmau refers to Raoult when discussing the structure of the test strip (see, e.g., para. [0189]). Raoult provides evidence that the test strip is a nitrocellulose test strip, as in claim 17 (see, e.g., p. 57, under “Introduction”, para. 1). Dalmau teaches providing a test strip with an antigen-containing solid phase coated with at least one immobilized recombinant intracellular neuronal protein, as in claim 17 (see, e.g., para. [0056]-[0059] and para. [0189]). It is understood that amphiphysin, recoverin, Hu, Yo, Ri, and CV2 of Dalmau (described in para. [0058]) and SOX1 (see para. [0189] of Dalmau) are equivalents to intracellular neuronal proteins as evidenced by para. [0042] of the applicant’s specification. Dalmau teaches the sample is a blood specimen, as in claim 17 (see, e.g., para. [0168]). Dalmau teaches binding the specimen to an intracellular neuronal protein immobilized on the test strip, as in claim 17 (see, e.g., para. [0056]-[0059] and para. [0189]). It is understood that amphiphysin, recoverin, Hu, Yo, Ri, and CV2 in embodiment 6 of Dalmau (described in para. [0058]) are equivalents to intracellular neuronal proteins as evidenced by para. [0042] of the applicant’s specification. Dalmau teaches optically measuring a color intensity of at least one antigen-antibody binding complex, as in claim 17 (see, e.g., para. [0189]: “The test strip may comprise a cut-off control band indicating the minimum staining that qualifies as an indication that an autoantibody has been detected”). It is understood that the staining of the cut-off control band is equivalent to optically measuring a color intensity of antigen-antibody binding complexes. Dalmau teaches providing an indication of positive for cancer if the concentration exceeds a predetermined concentration threshold, as in claim 17 (see, e.g., para. [0189]: “The test strip may comprise a cut-off control band indicating the minimum staining that qualifies as an indication that an autoantibody has been detected” and under “Abstract”: “The autoantibody can be used for diagnosing a neurological autoimmune disease or a cancer”). It is understood that the staining of the cut-off control band is equivalent providing an indication if the concentration of at least one antibody exceeds a predetermined concentration threshold.
Dalmau fails to teach adding a buffer to the specimen to form a composite specimen, as in claims 1 and 17. However, in a journal article reviewing lateral flow assays, Kaczula rectifies this deficiency. Kaczula recites “the sample is applied at one end of the strip, on the adsorbent sample pad” and “[the] sample pad is usually impregnated with buffer salts, proteins, surfactants and other liquids”, as in claims 1 and 17 (see p. 112, under “Principle of the lateral flow immunoassay” and p. 114, under “Sample pad”, respectively). It is understood that the buffer salts, proteins, surfactants and other liquids of Kaczula are equivalent to a buffer and are added to the sample when the sample is added to the sample pad.
Dalmau and Kaczula are analogous to the field of the claimed invention because they are both in the field of immunoassays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the sample pad containing buffers in the Dalmau assay. An artisan would have been motivated to do so because Kaczula teaches that the buffers “control the flow rate of the sample and to make it suitable for the interaction with the detection system” (see p. 114, under “Sample pad”). An artisan would have had a reasonable expectation of success based on the given disclosures.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dalmau (US 2023/0053910 A1, published 2023-02-23) as evidenced by Raoult, et al. (“The line blot: an immunoassay for monoclonal and other antibodies”, published 1989) and Koczula, et al. (“Lateral flow assays”, published 2016), as applied to claims 1-2, 4, and 17 above, and further in view of Urusov, et al. (“Towards Lateral Flow Quantitative Assays: Detection Approaches”, published 2019-07-17).
Dalmau and Koczula teach as set forth above, but they fail to teach the optical detection step is done using an optical scanner, as in claim 3. However, in a review article on lateral flow assays, Urusov rectifies this deficiency. Urusov recites, “An alternative approach to the digital imaging of test strips is using standard scanners”, as in claim 3 (see p. 7, under “3.3. Software for Processing Images and Obtaining Quantitative Assay Results”, para. 2).
Dalmau, Koczula, and Urusov are analogous to the field of the claimed invention because they are all in the field of immunoassays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the optical scanner of Urusov into the assay of Dalmau and Koczula. An artisan would have been motivated to do so because Urusov discloses, “In this case, traditional scanning produces a high-resolution image of a test strip, and it can be processed using existing software; that is, no special solutions for immunochromatography are required because the analysis of a test strip image does not differ much from electrophoresis data processing, for which software already exists” (see p. 7, under “3.3. Software for Processing Images and Obtaining Quantitative Assay Results”, para. 2). The use of existing software provides a benefit to the artisan that uses an optical scanner. An artisan would have had a reasonable expectation of success based on the given disclosures.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dalmau (US 2023/0053910 A1, published 2023-02-23) as evidenced by Raoult, et al. (“The line blot: an immunoassay for monoclonal and other antibodies”, published 1989) and Koczula, et al. (“Lateral flow assays”, published 2016), as applied to claims 1-2, 4, and 17 above, and further in view of Wang, et al. (“An overview on CV2/CRMP5 antibody-associated paraneoplastic neurological syndromes”, published 2023-03-31) and Tawa, et al. (“Transcriptomic profiling in canines and humans reveals cancer specific gene modules and biological mechanisms common to both species”, published 2021-09-27).
Dalmau and Koczula teach as set forth above, but they fail to teach providing an indication of lymphoma when detecting the antigen-antibody binding complex associated with CV2 in an animal, as in claim 6. However, in journal articles on CV2 antibody associated cancer, Wang rectifies these deficiencies. Wang discloses, “The CV2/CRMP5 antibody is now known as a high-risk antibody, and its presence indicates a potential tumor”, as in claim 6 (see p. 2359, under “Oncological associations”, para. 1). Wang further discloses, “CV2/CRMP5 antibody-associated PNS can also accompany breast cancer (Antoine et al., 1993; Wu et al., 2019), lymphoma” (see p. 2359, under “Oncological associations”, para. 1).
Dalmau, Koczula, Wang fail to teach CV2 for diagnosing lymphoma in animals, such as dogs, as in claim 6. However, in a journal article on understanding the relationships between cancer in pet canines and humans, Tawa rectifies this deficiency. Tawa discloses, “Towards this end we developed a protocol that analyzes canine transcriptomics data in the context of existing human data to evaluate comparative relevance of canine to human cancer. We used this protocol to characterize five canine cancers: melanoma, osteosarcoma, pulmonary carcinoma, B- and T-cell lymphoma, in 60 dogs” (see p. 2, under “Author summary”). Tawa continues by disclosing, “The demonstrated transferability of classification models from canines to humans enforces the idea that tumor biology, biomarker genes and therapeutics derived therefrom, in canines may translate to humans”, as in claim 6 (see p. 2, under “Author summary”).
Dalmau, Koczula, and Wang are analogous to the field of the claimed invention because they are all in the field of oncology. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use Wang’s disclosure of CV2 as a diagnostic biomarker for lymphoma in the assay of Dalmau and Koczula. An artisan would have been motivated to do so because Wang discloses, “About 90% of CV2/ CRMP5 antibody-associated PNS cases are accompanied by tumors” (see p. 2359, under “Oncological associations”, para. 1). The artisan would have a reasonable expectation of success based on the given disclosures.
Dalmau, Koczula, Wang, and Tawa are analogous to the field of the claimed invention because they are all in the field of oncology. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to utilize Tawa’s disclosure that the tumor biology and biomarkers of dogs and humans are transferable between these species to use the assay of Dalmau, Koczula, and Wang for lymphoma detection in dogs using CV2. An artisan would have been motivated to do so because Tawa discloses, “The demonstrated transferability of canine derived diagnostic models to the human case reinforces the idea that biomarkers used in the detection and treatment of cancers are shared between canines and humans” (see p. 3, last paragraph). An artisan would have had a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Raoult, et al. (“The line blot: an immunoassay for monoclonal and other antibodies”, published 1989) teaches that the test strip of Dalmau is a nitrocellulose test strip.
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/MICHAEL CAMERON SVEIVEN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678