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 of 18-22 in the reply filed on 3/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-17 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/26/2026.
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 20 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.
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 20 recites the broad recitation “said yeast strains”, and the claim also recites “Saccharomyces cerevisiae strains” 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.
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.
Subject Matter Eligibility - Step 1:
Claims 18-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural process without significantly more. The claim recites a series of steps or acts, including method of detecting cancer. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
Subject Matter Eligibility - Step 2A, Prong 1:
Regarding claims 18, the step of " assessing activation or non-activation of at least Sra-13, Str-2, Odr-10, Sra-17 and Str-130,wherein, when at least Sra-13, Str-2, Odr-10, Sra-17 and Str-130 are activated, said subject is determined to have cancer" is a step describing a correlation or relationship between the presence of response of a gene and cancer. This limitation sets forth a judicial exception, because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo). The step could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception, which may be termed a law of nature, an abstract idea, or both. Note that although the claim recites several nature-based product limitations (e.g., the sample and biomarker), the claim as a whole is focused on a process of detecting whether the biomarker is present in a sample, and is not focused on the products per se.
Regarding claims 19, the correlation is not resolved, because the limitations include two additional genes.
Regarding claim 20, the correlation is not resolved as it further modifies the detection method.
Regarding claim 21-22, the correlation is not resolved as it limits the type of cancer and the type of sample.
Subject Matter Eligibility - Step 2A, Prong 2:
This judicial exception is not integrated into a practical application because the step of "assessing activation or non-activation…said subject is determined to have cancer" is merely linking the abstract idea to the field of endeavor and would not be considered a particular practical application (MPEP 2106.05(h)). The claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the law of nature, the claim recites additional steps of "subjecting C. elegans to odorant stimuli with a biological fluid sample derived from a subject". Introducing a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary to use the correlation. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well- understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting an activation of a gene. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)). Therefore the limitation is not considered a particular practical application (MPEP 2106.05(h))
Regarding claims 19, there is not significantly more than the exception because the limitation merely adds genes to be observed. is not resolved, because the limitations include two additional genes.
Regarding claim 20,there is not significantly more than the exception because modifies the detection method that is well known and routine activity for diagnostics.
Regarding claim 21-22, there is not significantly more than the exception because it further limits the type of cancer and the type of sample.
Subject Matter Eligibility - Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the introducing and capturing biomarker steps are the other elements. Subjecting, and assessing gene activation of C. Elegans are well understood and conventional as evidenced by Hirotsu et al (US 20170016906, see rejection below for details). The claim is therefore not patent eligible.
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) 18-19, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirotsu et al (US 20170016906) in view of Milanetti et al, "Investigation of the binding between olfactory receptors and odorant molecules in C. elegans organism" Biophysical Chemistry 255 (2019) 106264, pp. 1-8.
Regarding claim 18, Hirotsu et al teach a method for detecting cancer comprising: subjecting C. elegans AWA and AWC GPCR receptors to odorant stimuli with a biological fluid sample derived from a subject (Para. 0259; Claim 7: urine), and assessing activation or non-activation of sra-17 (Table 5), str-2 (Table 4), odr-10 (Par. 0184), str-130 (Table 4) and wherein sra-17 (Table 5), str-2 (Table 4), odr-10 (Par. 0184), str-130 (Table 4) are activated (Para. 0184: detection of the expression of odr-10), said subject is determined to have cancer (Para. 0075: detect breast cancer). Hirotsu is silent to sra-13.
Milanetti et al teach genes encoding for GPCRs expression on AWC neurons including sra-13, str-2, str-130, srsx-5, and str-199 as well as odr-10 on the AWA neuron (p. 3 para. 2.1 Datasets). It is desirable to provide GPCRs genes in AWA and AWC that due to volatile compounds which express in the presence of cancer metabolites are indicative of cancer in patients (p. 2 col. 2 para 1). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a GPCRs gene expression that is linked to cancer is a result effective variable that gives the well-known and expected results of detecting cancer. In the absence of a showing of unexpected results, the Office maintains the sra-13 of Milanetti et al would have been within the skill of the art as optimization of a results effective variable to include in the method of Hirotsu.
Regarding claim 19, Hirotsu/Milanetti teach srsx-11 and str-199 (Hirotsu: Table 4), Hirotsu is silent to srsx-5. Milanetti et al teach genes encoding for GPCRs expression on AWC neurons including sra-13, str-2, str-130, srsx-5, and str-199 as well as odr-10 on the AWA neuron (p. 3 para. 2.1 Datasets). It is desirable to provide GPCRs genes in AWA and AWC that due to volatile compounds which express in the presence of cancer metabolites are indicative of cancer in patients (p. 2 col. 2 para 1). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a GPCRs gene expression activation or not activated that is linked to cancer is a result effective variable that gives the well-known and expected results of detecting cancer. In the absence of a showing of unexpected results, the Office maintains the srsx-5 of Milanetti et al would have been within the skill of the art as optimization of a results effective variable to include in the method of Hirotsu to determine if the subject is determined to have cancer.
Regarding claim 21, Hirotsu/Milanetti teach the cancer is breast cancer. (Para. 0073: breast cancer)
Regarding claim 22, Hirotsu/Milanetti teach the body fluid is urine. (Para. 0071: bodily fluid is urine)
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirotsu/Milanetti in view of Tehseen et al, "Functional Coupling of a Nematode Chemoreceptor to the Yeast Pheromone Response Pathway", PLoS One. 2014 Nov 21;9(11), pp. 1-21.
Regarding claim 20, Hirotsu teaches the fluorescent imaging of yellow cameleon gene to detect the activation neurons. (Para. 0184). Hirotsu is silent to said assessment is carried out by putting in contact with said biological fluid sample distinct Saccharomyces cerevisiae strains comprising each, a DNA coding for one of said AWC and/or AWA GPCR receptors, coupled to Saccharomyces cerevisiae Ga subunit so to express a GPCR- Ga chimera, each of said yeast strains also comprising a pheromone-responsive fluorescent transcriptional reporter gene, said GPCR receptors being at least Sra-13, Str-2, Odr-10, Sra-17 and Str-130;and when emission of fluorescence is observed in at least in Saccharomyces cerevisiae strains expressing Sra-13-Ga; Saccharomyces cerevisiae strains expressing Str-2-Ga;Saccharomyces cerevisiae strains expressing Odr-10-Ga; Saccharomyces cerevisiae strains expressing Sra-17-Ga and Saccharomyces cerevisiae strains expressing Str-130-Ga, Sra-13, Str- 2, Odr-10, Sra-17 and Str-130 GPCR receptors are assessed as activated.
Tehseen et al teach putting in contact with said biological fluid sample distinct Saccharomyces cerevisiae strains comprising each, a DNA coding for one of said AWC and/or AWA GPCR receptors, coupled to Saccharomyces cerevisiae Ga subunit so to express a GPCR- Ga chimera, each of said yeast strains also comprising a pheromone-responsive fluorescent transcriptional reporter gene, said GPCR receptors being Odr-10; and when emission of fluorescence is observed in at least in Saccharomyces cerevisiae strains expressing Odr-10-Ga GPCR receptors are assessed as activated (Abstract; p. 13: fluorescent reporter lacZ; Fig. 5). It is desirable to provide a robust assay for analysis of C. elegans GPCR function to enable de-orphaning of C. elegans chemoreceptors GPCR (p. 17, para. 1-2). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the assay of Hirotsu/Milanetti for the Saccharomyces cerevisiae Ga subunit assay of Tehseen et al to provide the above advantage of enabling de-orphaning of C. elegans chemoreceptors GPCR.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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