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 species election with traverse of the specific set of CpG sites: cg14543412, cg16070018, cg24440941, and cg22339775 in the reply filed on 08/06/2026 is acknowledged. The traversal is on the ground(s) that (1) All fifteen CpG sites identified in the present application demonstrate a single inventive concept-DNA methylation patterns that reliably indicate preeclampsia, independent of disease severity; and (2) the fifteen CpG sites function as an integrated diagnostic panel rather than separate species. This is not found persuasive because the claim does not require the use of the fifteen CpG sites as an integrated diagnostic panel. Further, as recited in the 103 rejection below, Toung teaches measuring the methylation levels of the recited CpG sites, thereby demonstrating lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Claims 1-8 are pending.
Claims 1-4 and 6-7 are under examination on the merits.
Priority
This application 18/683,683 filed on 02/14/2024 is a 371 national phase of PCT/KR2022/012378 filed on 08/19/2022, and claims the benefit of Republic of Korea Application No. 10-2021-0110050, filed on 08/20/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. It is noted that foreign priority is not perfected as no English translation was provided for the foreign priority document received on 02/14/2024. In order to perfect the foreign priority claim, please provide a certified English copy.
In the absence of a translated copy, the priority date of claim 1 and its dependents is determined to be 08/19/2022, the filing date of Republic of Korea Application No. 10-2021-0110050.
Information Disclosure Statement
The information disclosure statement filed 02/14/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98, which requires a legible copy of each cited foreign patent document. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Documents that were not considered have been lined through on the information disclosure statement. References 1 and 3 have been lined through because the references are to a patent and application respectively titled “Furniture tip over prevention system.”
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The use of terms which are trade names or marks used in commerce (including IIlumina® and Qiagen™ among others), has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claim 1 recites a method “for providing information necessary for diagnosing preeclampsia” in the preamble. This limitation is an intended result of performing the active step of the claimed method. Claim 1 further recites the active step “measuring a methylation level of one or more CpG sites —“. Under broadest reasonable interpretation the claim requires only measuring the methylation level of the recited CpG sites. Following the election of species, the claimed CpG sites are “the specific set of CpG sites: cg14543412, cg16070018, cg24440941, and cg22339775”. Thus, the claim is interpreted to require measuring the methylation levels of cg14543412, cg16070018, cg24440941, and cg22339775.
Claim Rejections - 35 USC § 112(b)
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 1-4 and 6-7 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.
Regarding claim 1, it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites “an analytical method for providing information necessary for diagnosing preeclampsia”. However, the method steps in the claim only require “measuring a methylation level of one or more CpG sites ---". Thus, it is unclear if applicant intends to cover any method of measuring a methylation level, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the latter, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal of diagnosing preeclampsia as set forth by the preamble of the claim. Amending the claim to include an active process step directed towards identifying the information necessary for diagnosing preeclampsia.
Claims 2-4 and 6-7 are similarly indefinite because they directly or indirectly depend from claim 1.
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 1-4 and 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Step 1
The claimed invention is directed to the statutory category of a process.
Step 2A, Prong One
The claim is (claims are) taken to be directed to an abstract idea, a judicial exception.
Claim 1 is directed to a method comprising “An analytical method for providing information necessary for diagnosing preeclampsia”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, “providing information necessary for diagnosing” encompasses the mental process of making a decision regarding which data are required to make a diagnosis and choosing that data.
Claims 2-4 and 6-7 depend from claim 1, and require the same mental process.
Step 2A, Prong Two
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception.
While claim 1 further recites the active step of “measuring a methylation level of one or more CpG sites”, this is not an integration of the exception into a practical application. Instead, this element is data gathering required to perform the method.
Additional dependent claims further recite limitations directed towards data gathering required to perform the method. These include limiting the subject’s sample to a placental sample, limiting the method for measuring the methylation level to methylation-specific quantitative real-time polymerase chain reaction, and measuring hypermethylation of CpG sites.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not add a specific limitation other than what is well-understood, routine, and conventional in the field. Steps directed to measuring methylation levels are techniques that are routine, conventional, and well-known in the art as demonstrated in the 103 rejection documented below.
Claim Rejections - 35 USC § 102
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 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, 2, and 4 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Li et al. (Differential placental methylation in preeclampsia, preterm and term pregnancies. 2020. Placenta. (93): 56-63) as evidenced by Illumina Infinium HumanMethylation850 BeadChip Manifest (from www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GPL23976. Public on 09/01/2017).
Regarding claim 1, Li teaches a method for identifying methylation levels of genes associated with preeclampsia (p. 56) (Abstract). Li teaches measuring methylation levels using the Illumina Infinium HumanMethylation850 K BeadChip (p. 56, Abstract and p. 57, col. 1), which includes the CpG sites cg14543412, cg16070018, cg24440941, and cg22339775. Thus, as evidenced by Illumina Infinium HumanMethylation850 BeadChip, Li teaches measuring the methylation levels of the selected CpG sites.
Regarding claim 2, Li teaches collecting placental tissues from the maternal side of the placenta within 15 min after delivery (p. 57, col. 1), which reads on placenta externally discharged from a pregnant woman.
Regarding claim 4, Li teaches measuring levels of hypermethylation (p. 56, Abstract and p. 58, col. 1-2, Fig. 1), which reads on measuring whether one or more CpG sites (on the Illumina Infinium HumanMethylation850 K BeadChip) are hypermethylated.
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.
Claims 1-3, and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Differential placental methylation in preeclampsia, preterm and term pregnancies. 2020. Placenta. (93): 56-63) as evidenced by Illumina Infinium HumanMethylation850 BeadChip Manifest (from www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GPL23976. Public on 09/01/2017) and in view of Anderson et al. (US 20160369339, on IDS dated 02/14/2024).
The teachings of Li as they relate to claims 1 and 2 are stated in the 102 rejection above in this office action.
Regarding claims 3 and 6, Li does not teach measuring a methylation level is carried out by methylation-specific quantitative real-time polymerase chain reaction.
Anderson teaches a method for identifying biomarkers for preeclampsia comprising measuring methylation levels (abstract) using the Illumina Infinium DNA methylation 450K bead-based array (para 70).
Anderson teaches the determination of the methylation level/state of a gene can be measured by methods available and known to an art worker, for example, by Methylation-Specific PCR (MSP) (para 37-38), which reads on measuring a methylation level by methylation-specific quantitative real-time polymerase chain reaction.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li and Anderson to arrive at the instantly claimed invention. The modification would have entailed using MSP to measure methylation levels in the method of Li. One of skill in the art would have known the method of methylation-specific PCR and performing MSP would have been routine and conventional to one of skill in the art. One would have been motivated by the accessibility of PCR technology and the ability to design probes to measure methylation. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 7, Li teaches measuring levels of hypermethylation (p. 56, Abstract and p. 58, col. 1-2, Fig. 1), which reads on measuring whether one or more CpG sites are hypermethylated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA GRAY whose telephone number is (571)272-0116. The examiner can normally be reached Monday-Friday 8-5 with second Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, WINSTON SHEN can be reached at (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
