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 .
Status of Claims
The preliminary amendment filed on 02/28/2024 amended claims 8 and 10 and added new claims 15 and 16. Claims 1-16 are pending and will be examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on 04/08/2022 and 11/11/2022. It is noted, however, that applicant has not filed a certified copy of the KR10-2022-0044131 or the KR10-2022-0150152 application as required by 37 CFR 1.55.
Therefore, as there is no translated copy of the foreign priority applications, it cannot be determined if they disclose the claimed invention. Therefore, the effective filing date of the claimed invention is considered to 02/20/2023, the date of filing for PCT/KR2023/002384, for the purposes of applying prior art.
Information Disclosure Statement
The Information Disclosure Statements filed on 05/21/2024 and 01/22/2026 have been considered. Signed copies are enclosed.
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 1-16 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.
Claim 1 recites “A peptide represented by SEQ ID NO:1”. Claims 4, 6, 11, and 16 recite “a peptide represented by SEQ ID NO:2”. “Represented by” is not language commonly used in the art to describe the sequence of a peptide. The specification does not provide a definition for or any parameter that would result in a peptide being “represented by” a sequence. Examiner suggests amending the claims to recite “a peptide of SEQ ID NO:1” and “a peptide of SEQ ID NO:2”, or replacing the language of “represented by” with more commonly used language, such as “comprising” or “consisting of” (see MPEP § 2111.03). For the purposes of applying prior art, Examiner will be interpreting the claims as “a peptide comprising SEQ ID NO: 1”. No dependent claim rectifies this problem, and therefore claims 2-3, 5, 7-10, and 12-15 inherit this rejection.
Claim 11 is indefinite due to the recitation of steps (a), (a’), (b), (b’), and (c). The labeling of the steps makes it unclear if step (a’) requires step (a), is a further limitation of step (a), or is a modified step (a). Similarly, (b’) is unclear. If all steps are required, Examiner suggests amending the claim to recite steps (a)-(e). If only one of step (a) or (a’) is required, Examiner suggests amending (a’) to be an alternate clause of (a). For example, “(a) contacting a sample…of claim 8, or contacting a sample…with a nano-self assembly of a bacteriophage in which the peptide represented by SEQ ID NO: 2 is externally expressed.”
Claim 14 recites “the RGB pattern in step (b) is analyzed for the color change pattern after conversion to black and white.” A color change pattern cannot be observed in black and white. Appropriate correction is required.
Claim 12 recites “the sample is selected from the group consisting of whole blood…and cerebrospinal fluid obtained from a separated organ, tissue, cell, or subject.” It is unclear if the final clause applies to the entire list of samples in claim 12, or only the cerebrospinal fluid, as currently suggested by the grammatical structure. If the latter, the claim is indefinite because cerebrospinal fluid cannot be obtained from a cell. If the clause is intended to apply to the entire Markush group, Examiner suggests amending the claim structure. For example, “the sample is selected from the group consisting of: whole blood…and cerebrospinal fluid, and wherein the sample is obtained from a separated organ, tissue, cell, or subject.”
Claim 12 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of 12 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the majority of the recited samples have the common structural feature of being liquids. However, "breath" is a gas, not a liquid, and would be difficult to use in the method of claim 10..
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Examiner also suggests Applicant may remove the term “breath” from the group.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites "the peptide of claim 1, wherein the peptide is a peptide for detecting ovarian cancer." The intended use of the composition does not hold patentable weight. See MPEP §2103/2111. Therefore, claim 2 does not recite any further meaningful limitation to the peptide of claim 1. Claim 3 recites "a composition for diagnosing ovarian cancer, comprising the peptide of claim 1." As claim 3 does not recite any additional elements that are required in the composition, the composition of claim 3 is not distinguishable from the peptide of claim 1. Therefore, claim 3 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 15 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a method for diagnosing ovarian cancer. This judicial exception is not integrated into a practical application because all steps can be performed by a human using mental steps or basic critical thinking. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis
Applicant’s claims 15 and 16 recite methods of diagnosing ovarian cancer. The claim recites a series of steps or acts. Thus the claim is directed 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 only step of the claim is comparing the expression level of CA125 in a subject with a control group. 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. Additionally, the step of diagnosing 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 (Step 2: Yes), which may be termed a law of nature, an abstract idea, or both.
Next, 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.
Dochez et al. (J Ovarian Res 12, 28 (2019)) teach that it is routine in the art to measure levels of CA125 and HE4 and to diagnose ovarian cancer when these levels are elevated (abstract, whole document). Dochez et al. also teaches that this can be done using immunoassays, which involve binding the marker to a peptide and detecting its presence (see page 4, left column). Thus, claims 15 and 16 recite diagnostic methods that are well understood, routine, and conventional in the art, and are directed to known markers of ovarian cancer. Therefore, the combination of elements is not sufficient to ensure that the claimed method amounts to significantly more than the exception.
On February 6, 2019, the United States Court of Appeals for the Federal Circuit (CAFC) found in Athena Diagnostics V. Mayo Collaborative Services that diagnostic methods are not patent subject matter eligible unless they embody a separate technical improvement beyond the correlation of molecules in bodily fluids to particular diseases/conditions.
Claims drawn to diagnostic uses of underlying natural phenomena regardless of the reagents employed or the starting samples used have been found not patent eligible, because once the newly discovered natural phenomenon is removed from the claims, the remaining elements merely recite routine, conventional, and well-understood steps that cannot provide the inventive concept to transform the methods into patent eligible subject matter. See Myriad Genetics; In re BRCA1 - and BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014); Arisoa Diagnostics, Inc. V. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015) (en banc petition denied) (cert. denied); Genetic Tech. Ltd. V. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Cleveland Clinic Foundation V. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); Roche Molecular Systems, Inc. V. CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018); Genetic Veterinary Sciences, Inc. V. Laboklin GmbH & Co. KG, 933 F.3d 1302 (Fed. Cir. 2019).
Accordingly, claims 15 and 16 are not patent eligible.
Closest Prior Art
Claims 1-16 are free of the prior art. The closest prior art is:
Dochez et al., J Ovarian Res 12, 28 (2019), teach that detecting CA125 and HE4 together is the current most efficient method of diagnosing ovarian cancer. The novel concept of the invention is not simply the detecting, however, but the peptide and the method of claim 10.
Shin et al. (February 2019), "Phage-Based Point-of-care Biosensor to Detect Salivary Biomarkers in Ovarian Cancer," Master's Thesis, Ajou University Graduate School, College of Pharmacy, discloses a very similar method of diagnosing ovarian cancer using a 12 nucleotide peptide that binds to CA125 expressed on a phage, and analyzing for RGB color change patterns. However, Shin et al. does not disclose the peptide as having SEQ ID NO:1. Therefore, Shin et al. does not anticipate the current claims.
Conclusion
No claims are allowed.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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