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 the species of “the set of biomarkers consisting of 3-methylguanine, 5-methylcytosine, butyric acid, and urea” for the genus of biomarkers in the reply filed on 07/07/2026 is acknowledged. The traversal is on the ground(s) that the recited biomarkers are unified by a common use disclosed throughout the specification (remarks, page 12). This argument has been fully considered but is not found persuasive because searching every biomarker that can potentially be assessed in a bile sample from a subject, both individually and in all possible combinations, certainly constitutes an undue burden of search.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 07/17/2026 has been entered. Claims 2-3, 7, 11, 14, 18, 21, 24, 26, 28, 30, 34-35, 38, and 40-44 are pending in this US patent application. Claims 11, 14, 18, 21, 24, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/17/2026.
Claims 2-3, 26, 28, 30, 34-35, 38, 40-41, and 43-44 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 05/21/2025 has been received and considered.
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.
Claims 3, 7, 35, and 38 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.
The rejected claims each depend from claim 2 but recite limitations of things that are not recited in claim 2: “the pancreaticobiliary condition” in claim 3, “assessing a pancreaticobiliary condition in a subject” in claims 7 and 35, and “treating the subject for the pancreaticobiliary cancer” in claim 38. As such, these claims lack proper antecedent basis to claim 2, which causes confusion because it is unclear which of the limitations of claim 2 these claims are supposed to further limit. Accordingly, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 3, 7, 35, and 38, rendering them indefinite, and these claims are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, “the pancreaticobiliary condition” in claim 3 is interpreted as “an indeterminant biliary structure” as recited in claim 2. “Assessing a pancreaticobiliary condition in a subject” in claims 7 and 35 is interpreted as an additional step 2(a)(ii) that occurs along with the assessment of bile biomarker levels in the subject. “Treating the subject for the pancreaticobiliary cancer” in claim 38 is interpreted as a further limitation of the step of “seeking further review of the subject” in claim 2.
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 2-3, 26, 28, 30, 34-35, 38, and 40-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) not be directed to a judicial exception or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Directed to a judicial exception’ analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
Claim 2 recites a step of assessing levels of biomarkers in a bile sample from a subject and performing separate steps if the biomarker levels indicate malignancy or a benign condition. The decision required to determine whether the patient should receive the treatments recited in 2(b)(i) or 2(b)(ii) is a mental step, which is an abstract idea, and depends on the relationship between bile biomarker levels and the presence of particular pancreaticobiliary conditions, which is a natural phenomenon. As such, claim 2 recites a judicial exception, as do all of its dependent claims.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 2 recites that depending on the biomarker level, a patient will receive either the treatment steps recited in step 2(b)(i) or step 2(b)(ii). However, at least one embodiment of each of these steps is recited at a high level of generality: “seeking further review of the subject” and “conducting additional imaging.” Neither of these steps constitutes a particular treatment or prophylaxis for the condition, which is required to integrate the judicial exception into a practical application. See MPEP § 2106.04(d). Similarly, claim 35 recites a number of nonspecific steps that may be performed on the subject, which do not represent a particular treatment or prophylaxis for any condition. Similarly, claim 41 limits the step of “seeking further review of the subject” by reciting various physicians or groups from whom review is sought, but no further delineation of the type of review is recited. As such, claim 41 cannot be interpreted to recite a particular treatment or prophylaxis for any condition.
Claims 28, 30, and 34 recite limitations of the process of obtaining the bile sample that is assessed in the method of claim 2. As such, these claims represent insignificant extra-solution activity because they are required for the judicial exception step in claim 2.
Please note that, while claims 38 and 40 do require particular types of treatment or imaging, respectively, to be performed on a subject based on their bile biomarker levels, the steps of claim 38 and 40 are still optional steps that are not required to be performed in the method of claim 2 because the method of claim 2 may not indicate that the patient has a malignant (claim 38) or benign (claim 40) condition. As such, claims 38 and 40 also cannot be interpreted to integrate the judicial exception of claim 2 into a practical application because their steps are not required to be performed.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because none of the additional steps recited in the dependent claims are other than well-understood, routine, and conventional.
Therefore, claims 2-3, 26, 28, 30, 34-35, 38, and 40-41 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Election/Restrictions
The instant claims are free of the prior art in light of the elected set of biomarkers, “3-methylguanine, 5-methylcytosine, butyric acid, and urea”. The closest prior art to the claimed invention is found in the teachings of Zubareva, discussed below. However, this reference does not teach the measurement of all four of these biomarkers in the bile samples taken from the subject. As such, the claims are free of the prior art in light of Applicant’s elected set of biomarkers. Accordingly, the Examiner has selected another set of biomarkers, “urea”, that falls within the scope of the genus of “one or more biomarkers” recited in instant claim 2 for further examination at this time. In light of the Examiner’s selection, claims 11, 14, 21, 24, and 42-44 are withdrawn from examination at this time.
Claims 2-3, 7, 18, 26, 28, 30, 34-35, 38, and 40-41 are currently under examination and were examined on their merits.
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.
Claims 2-3, 7, 18, 26, 28, 30, 34-35, 38, and 40-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russian patent application RU 2109284 filed by Zubareva et al., published 04/20/1998.
Please note that the page and paragraph numbers cited below refer to the English translation of this document attached to this Office action.
Zubareva teaches determination of the concentration of urea in the bile of patients with external drainage of the bile ducts in the bile (see entire document, including page 2, paragraph 9; reads on claims 28 and 30; reads on step (a) of claim 2; the Examiner notes that any removal of a fluid from the body can be interpreted as a “fluid biopsy”). Some of the bile is removed from the patient’s drainage tube for urea analysis, and 100 µL is a sufficient amount of bile (page 2, paragraph 11; reads on claims 18 and 34). If the urea concentration in the bile sample is higher than 8.3 mmol/L, the patient is diagnosed with uremia (page 2, paragraph 7; reads on claim 26). In a specific embodiment, a patient with symptoms including itching and weight loss was hospitalized (page 2, paragraph 17; reads on claim 3). The biliary tract was drained by percutaneous drainage, and the urea content was measured to be 9.8 mmol/L. As the drainage failed to decompress the biliary tract, the patient underwent surgery, during which a metastatic liver cancer was detected and a biopsy was performed (page 3, paragraph 1; reads on claims 7, 35, 38, and 40-41; reads on step (b)(i) of claim 2; the Examiner notes that the surgical procedures and biopsy performed on the patient can be interpreted as “further review” and the physician who diagnosed the metastatic liver cancer can be interpreted as an “oncology specialist”; the evaluation of the biopsy sample can be interpreted as “histology”; because the patient was assessed to have a malignant condition, the step of claim 40 is optional).
As such, claims 2-3, 7, 18, 26, 28, 30, 34-35, 38, and 40-41 are anticipated by Zubareva and are rejected under 35 U.S.C. 102(a)(1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 10/03/2026
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