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 .
DETAILED ACTION
1. Applicant’s election without traverse of Group II (claims 10-15, 18) in the reply filed on May 28, 2026 is acknowledged.
Status of the Application
2. Claims 10-15 and 18 are considered for examination. Claims 1-9 and 16-17 are withdrawn from further consideration as being drawn to nonelected group.
Priority
3. This application filed on December 21, 2023 is a 371 of PCT/KR008902 filed on June 22, 2022 which claims foreign priority to KR10-2022-0076394 filed on June 22, 2022 and KR10-2021-0080807 filed on June 22, 2021.
Objection to the Specification
4. Claim 18 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
5. 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 10-15 and 18 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. Claims 10 and 18 recite ‘measuring the expression of stanniocalcin-1 (STC1) of claim 1’. It is not clear if the biological sample comprises STC1 of claim 1 or STC1 as biomarker. The specification discloses the isolated STC1 and the STC1 in the biological sample is one and the same. It is not clear the dependency on STC1 of claim 1 is different from the STC1 in any biological sample.
Claim Rejections - 35 USC § 102
6. 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. Claims 10-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kasper et al. (US 2007/0134670).
Kasper et al. teach an information proving method or a method of claim 10, 18, for diagnosing or predicting the metastasis or prognosis of cancer comprising:
isolating a biological sample from a subject (para 0010-0011, 0117-0119, 0123, 0144-0145, 0181-0182, 0016-0019);
measuring the expression level of Stanniocalcin-(STC1) in the biological sample (para 0010-0011, 0117-0119, 0123-0135, 0144-0148, 0181-0184, 0016-0019; and
comparing the expression level of STC1 with a reference value of a control group (normal control group) (para 0010-0011, 0117-0119, 0125-0135, 0144-0148, 0155, 0184-0185, 0016-0019).
With reference to claim 11, Kasper et al. teach that the biological sample is from blood, plasma, tissue biopsy (para 0016, 0118, 0144).
With reference to claim 12, Kasper et al. teach that cancer is determined by an increased (abnormal) expression of STC 1 compared to the reference value of the control group (para 0011, 0119).
With reference to claim 13, Kasper et al. teach that the cancer is breast, and colon cancer (para 0142).
With reference to claims 14-15, Kasper et al. teach that an increase in the growth, invasion or migration of cancer cells or clinical stage of cancer is determined by an increase in the expression of STC1 (para 0010-0011, 0119, 0155, 0016). For all the above the claims are anticipated.
B. Claims 10-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birrer et al. (US 2010/0286237).
Birrer et al. teach an information proving method or a method of claim 10, 18, for diagnosing or predicting the metastasis or prognosis of cancer comprising:
isolating a biological sample from a subject (para 0010-0011, 0159, 0268-0280, 0284-0285);
measuring the expression level of Stanniocalcin-(STC1) in the biological sample (para 0010-0011, 0159, 0268-0280, 0286-0287: indicating at least one tumor associated molecule of tables 1-5, which includes STC1 biomarker in table 1 and 5) and
comparing the expression level of STC1 with a reference value of a control group (para 0010-0011, 0268-0280, 0286-0287, table 1 and 5).
With reference to claim 11, Birrer et al. teach that the biological sample is from tissue (para 0271, 0284-0285).
With reference to claim 12, Birrer et al. teach that cancer is determined by an increased expression of STC 1 compared to the reference value of the control group (para 0011, 0159, 0273-0280, 0286-087, table 1 and 5).
With reference to claim 13, Birrer et al. teach that the cancer is ovarian cancer (para 0010-0011, 0159, 0284-0285).
With reference to claims 14-15, Birrer et al. teach that an increase in the growth, invasion or migration of cancer cells or clinical stage of cancer is determined by an increase in the expression of STC1 (para 0010-0011, 0268-0280, 0159, table 1, 5). For all the above the claims are anticipated.
Claim Rejections - 35 USC § 101
7. 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 10-15 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claim(s) recite a method for diagnosing or predicting the metastasis or prognosis of cancer, a process, statutory category. Claims 10-15 and 18 recite a judicial exception (law of nature, natural phenomenon) because claims recite diagnosis or predicting metastasis or prognosis of cancer in a subject based on the expression of STC1, which is a law of nature or natural phenomenon that exits in nature. The claims 10-15 and 18 do not include any additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps (isolating biological sample and measuring expression level) which do not add significantly more to the claimed method. The additional steps are not themselves natural laws, but neither are they sufficient to transform the nature of the claims because they consist of well-understood, routine, conventional activity already engaged in by the scientific community. The additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community (Kasper et al. (US 2007/0134670); Birrer et al. (US 2010/0286237). The additional steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. This judicial exception is not integrated into a practical application because the judicial exception is not markedly different from the natural phenomenon because the claims recite the abstract idea of determining by a computer processing. It is noted that a judicial exception itself, such as an abstract idea, cannot be considered to meet the criteria of "significantly more" than a judicial exception. The Courts decision rested upon an examination of the particular claims in light of the Court's precedents, specifically Bilski, Flook and Diehr. The Court repeated the long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U.S.C. § 101. In conducting the analysis, the Court addressed the "machine-or-transformation" test explained in Bilski with a reminder that the test is an "important and useful clue" to patentability but that it does not trump the "law of nature" exclusion. A claim that recites a law of nature or natural correlation, with additional steps that involve well-understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation. On the other hand, reaching back to Neilson, the Court pointed to an eligible process that included not only a law of nature (hot air promotes ignition) but also several unconventional steps involving a blast furnace) that confined the claims to a particular, useful application of the principle. For all the above, the claims are rejected under 35 USC 101.
Conclusion
No claims are allowable.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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