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 without traverse of Group I, claims 1-3, 5-7 and 10, and new claims 21-24, in the reply filed on March 27, 2026 is acknowledged.
This Restriction/Election Requirement is made FINAL.
Claim Status
Claims 1-3, 5-7, 10, and 21-24 are pending. Claims 8-9, and 11-20 are canceled. Claims 21-24 are newly added. Claims 1-3, 5-7, 10, and 21-24 are examined herein.
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 1-3, 5-7, 10, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is drawn to a method of screening for cancer in a subject, the method comprising: detecting a behavioral, chemotaxis, and/or a neuronal response of a nematode to a biological sample obtained from the subject; determining whether the response exceeds or is within a threshold for a positive response, wherein a positive response indicates the subject has cancer or is at risk for having cancer; and identifying the subject as having cancer or as being at risk for having cancer.
Claim 23 is drawn to a method of screening for cancer in a companion animal, the method comprising: detecting a behavioral, chemotaxis, and/or a neuronal response of a nematode to a biological sample obtained from the companion animal; determining whether the response exceeds or is within a threshold for a positive response, wherein a positive response indicates the companion animal has cancer or is at risk for having cancer; and identifying the subject as having cancer or as being at risk for having cancer.
The claim recites a step or act, i.e., to a process, which is one of the statutory categories of invention (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claim recites a step of detecting a response, determining whether the response is within a predetermined range, and identifying a subject. These steps of are recited at a high level of generality that merely requires a comparison of data or information and imposes no limits on how the steps are performed. In Myriad CAFC, the court found this step of comparing to be an abstract idea.
It is apparent that the steps of detecting, determining and identifying could be performed by a human using mental steps or basic critical thinking. Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC. The specific information that is being processed (responses from nematodes) merely narrows the abstract idea, which does not make the steps less abstract and is not sufficient to provide eligibility on its own. Thus, the claims are directed to an abstract idea (Step 2A: YES).
Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the abstract idea. The claims recite the steps of detecting, determining and identifying, all of which were identified as the abstract idea explained above. There are no other elements/steps recited in the claims. This judicial exception is not integrated into a practical application. Accordingly, the claims as a whole do not amount to significantly more than the abstract idea of comparing information (Step 2B: NO). The claims are not patent eligible.
Dependent claims 2-3, 5-7, and 10 recite limitations thar serve to further narrowing the scopes of the responses, or the cancer types, etc., and do not make the less abstract and are not sufficient to make the claims amount to significantly more than the abstract idea.
Dependent claim 22 recites a computer-implemented method, a computer system, or a computer readable medium. Since the “computer readable medium” is recited as an optional alternative, the claim still encompasses subject matter that only requires a “computer-implemented method” which is also regarded as being abstract. Therefore, claim 22 is still included in this rejection.
Claims 21 and 24 further recites a step of “recommending”, which is also considered a mental process that are not sufficient to make the claims amount to significantly more than the abstract idea.
Therefore, claims 1-3, 5-7, 10 and 21-24 are rejected under 101.
Claim Rejections - 35 USC § 112
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.
Claim 21 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.
Claim 21 recites the limitation " the companion animal" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 10, 21, and 23-24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by HIROTSU (PGPUB US 20210215669 A1. Published on July 15, 2021; filed on August 14, 2019).
Claim 1 is drawn to a method of screening for cancer in a subject, the method comprising: detecting a behavioral, chemotaxis, and/or a neuronal response of a nematode to a biological sample obtained from the subject; determining whether the response exceeds or is within a threshold for a positive response, wherein a positive response indicates the subject has cancer or is at risk for having cancer; and identifying the subject as having cancer or as being at risk for having cancer.
Claim 23 is drawn to a method of screening for cancer in a companion animal, the method comprising: detecting a behavioral, chemotaxis, and/or a neuronal response of a nematode to a biological sample obtained from the companion animal; determining whether the response exceeds or is within a threshold for a positive response, wherein a positive response indicates the companion animal has cancer or is at risk for having cancer; and identifying the subject as having cancer or as being at risk for having cancer.
HIROTSU discloses a method for diagnosing for cancer in a non - primate mammal , the method comprising : evaluating taxic behavior of nematodes toward a urine sample from the mammal. (Claim 1); wherein the mammal is a mammal selected from a canine, a feline or a rodent (Claim 2); the canine, feline or rodent mammals read on the instant claimed “subject” or “companion animal”. and wherein the cancer is a hematopoietic tumor, an epithelial cancer, or a non-epithelial sarcoma (Claims 6-8); wherein the evaluating comprising placing the urine sample obtained from the mammal into a container comprising a solid medium; placing the nematodes separated at a predetermined distance from the urine sample in the container; and then allowing the nematodes to move; comparing a difference or ratio between a first number of the nematodes approaching the test sample to a second number of nematodes far from the urine sample; and evaluating the nematodes exhibiting taxic (i.e., chemotaxis) attractive behavior as positive response for cancer (Claims 16-18).
In particular, HIROTSU discloses that when the nematodes exhibit attractive behavior , the subject can be evaluated to suffer from cancer or to have the possibility of having cancer ([0022]); that this method of analyzing urine with nematodes can include determining that the subject suffers from cancer or has the possibility of suffering from cancer when the nema todes exhibit taxic behavior toward the test sample ([0027]).
Furthermore, HIROTSU discloses subjects that have been evaluated to have cancer by the nematode testing method can then be treated for cancer, or undergo more detailed examination (i.e., further diagnosis) to receive a definitive diagnosis of cancer.
Claim 2 is drawn to the method of claim 1, wherein the nematode is a wildtype, a mutant or a transgenic nematode. Claim 3 recites wherein the nematode is a wildtype, a recombinant or a transgenic Caenorhabditis elegans. HIROTSU discloses using wild-type nematode Caenorhabditis elegans (e.g., [0014], [0019]).
Claim 5 is drawn to the method of claim 1, wherein the positive response comprises chemotaxis toward the biological sample. As discussed above, HIROTSU discloses moving (taxic) behavior toward the diluted urine sample, therefore reads on chemotaxis toward the biological sample.
Claim 6 is drawn to the method of claim 1, wherein the biological sample is urine. As discussed above, HIROTSU discloses the sample being urine.
Claim 10 is drawn to the method of claim 1, wherein the subject is a companion animal. As discussed above, HIROTSU discloses the subject being a dog or cat.
Claims 21 and 24 are drawn to the method of claim 1, wherein the method further comprises recommending diagnostic testing. As discussed above, HIROTSU discloses the method further comprising more detailed examination to receive a definitive diagnosis.
Therefore, claims 1-3, 5-6, 10, 21, and 23-24 are anticipated by the prior art.
Claims 1-3, 5-7, and 22, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by HIROTSU (PGPUB US 20170016906 A1. Published in 2017).
Regarding claims 1-3 and 5-6, HIROTSU discloses a method for detecting cancer, using, as an indicator, the reaction of nematodes to a bio-related substance (biological sample) of a subject (Claim 1); wherein the nematode is Caenorhabditis elegans (Claim 2); wherein the nematode is a wild-type nematode, a mutant nematode, or a transgenic nematode (Claim 3); wherein when the nematode shows a positive response, the subject is determined to have cancer, or to have cancer risk (Claim 4); wherein the sample is urine (Claim 6-7).
Claim 7 is drawn to the method of claim 1, wherein the cancer is lymphoma. HIROTSU discloses the detection method that “To date, it has been confirmed that gastric cancer, colon/rectal cancer, esophageal cancer, pancreatic cancer, prostate cancer, bile duct cancer, breast cancer, malignant lymphoma, gastrointestinal stromal tumor, cecal cancer, and lung cancer can be detected by the present cancer diagnosis system”.
Claim 22 is drawn to the method of claim 1, wherein the method further comprises using a computer-implemented method, a computer system, or a computer readable medium in at least one of the detecting, determining, or identifying steps. Regarding claim 22, HIROTSU discloses a system that has a processing part 20 for processing the detected information; that further comprise a preservation part 40 for preserving the data processed in the processing part 20. The preservation part 40 comprises program and database, which are for use in detection of cancer. ([0159]; and Fig. 16A which cites a computer program in part 40).
Therefore, claims 1-3, 5-7, and 22, are anticipated by the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663
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