DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed June 1, 2026. Currently, claims 1-2, 4-17 are pending. Claim 2 has been withdrawn as directed to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
The 102 rejections, namely Tothill and Resinger, over expression analysis have been withdrawn in view of the amendments to the claims.
Election/Restrictions
Applicant's election without traverse of ZSCAN12 species in the paper filed December 18, 2025 is acknowledged.
Priority
This application is a 371 of PCT/EP2022/051512, filed January 24, 2022 and claims priority to EPO 21305086.7, filed January 25, 2021 and EPO 21306344.9, filed September 28, 2021.
Drawings
The drawings are acceptable.
Non-Compliant Amendment
The instant claims are not a proper markup of the previously pending claims. Previously pending claims recited “detecting of” which is not marked up in the instant claims. Further, the comma after determining the level of has been omitted. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
As noted above, the amendment under consideration herein fails to comply with 37 CFR 1.121 because the claim listing does not contain the appropriate markings indicating matter removed from the amended claims. Thus, the amendment could be considered non-responsive. In the interest of compact prosecution the amendment at issue will not be considered non-responsive. However, any future responses failing to comply with 37 CFR 1.121 will be held non-responsive, and will not be considered
Improper Markush Rejection
Claims 1, 4-17 are 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.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117.
Here each species is considered to each of the genes. OXT and ZSCAN12 are located on different chromosomes and have different structures. Figure 2 illustrates different methylation patterns.
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different gene that could be detected is itself located in a separate region of the genome and has its own structure. The genes recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequences with different expression and methylation patterns. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with colorectal cancer. Accordingly, while the different markers are asserted to have the property of being expressed in colorectal cancer, they do not share a single structural similarity.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”
The recited genes do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the genes will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited genes would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited genes possess the common property of being associated with endometrial or ovarian cancer.
MPEP 2117 (II) further states the following:
Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of genes being claimed because it is shared by ALL nucleic acids. Further, the fact that the genes all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of being associated with endometrial or ovarian cancer.
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.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
Response to Arguments
The response traverses the rejection. The response asserts the amendment to the claims clarify the level of methylation is for a ZSCAN12 gene, OXT gene or both.
This argument has been considered but is not convincing because the claim remains directed to different alternatives, particularly ZSCAN12 and OXT. The amendment does not remedy the recitation of distinct alternatives in the same claim. Thus, for the reasons above and those already of record, the rejection is maintained.
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, 4-17 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.
Question 1
The claimed invention is directed to a process that involves a natural principle and a judicial exception.
Question 2A Prong I
The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon.
Claim 1 is directed to “an in vitro method for detecting and treating endometrial carcinoma in a human subject by determining methylation status of elected ZSCAN12 gene, comparing the methylation status with a reference methylation state and administering a therapeutic treatment “when” hypermethylation is detected”.
Claim 9 is further directed to a decreased is indicative of a benefit of the therapeutic treatment. Thus, the decrease is a recitation of a comparison or abstract idea and the indicative is a natural phenomenon.
Claim 12 is directed to “indicative of a risk of relapse” after persistent hypermethylation is also a recitation of a comparison or abstract idea and the indicative is a natural phenomenon. Claim 13 and 14 are similarly directed to residual disease and therapeutic resistance.
Claim 1 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “detecting an endometrial carcinoma”, and “comparing the determined methylation status with a reference methylation state”) and a law of nature/natural phenomenon (i.e. the natural correlation between the hypermethylation status of ZSCAN12 and endometrial carcinoma). Claims 9-14 which require uses of methylation state are also laws of nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Herein, claim 1 involves the patent-ineligible concept of an abstract process. Claim 1 requires performing the step of “detecting or monitoring an endometrial carcinoma or an ovarian carcinoma”. Neither the specification nor the claims set forth a limiting definition for "detecting or monitoring" and the claims do not set forth how “detecting or monitoring” is accomplished. As broadly recited the detecting or monitoring step may be accomplished mentally by thinking about a subject’s level or methylation of ZSCAN12 and assessing whether the subject has endometrial carcinoma. Alternatively, the claim encompasses obtaining information from a database to detecting the level or methylation of ZSCAN12. Thus, the detecting or monitoring step constitutes an abstract process idea.
Claim 1 further recites a comparison between the methylations status and a reference methylations state that is deemed an abstract idea (see MPEP 2106.04(a)(2)(III)(A); • claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014)).
A correlation that preexists in the human is an unpatentable phenomenon. The association between methylation states such as elected ZSCAN12 methylation state and risk of endometrial cancer is a law of nature/natural phenomenon. The preamble and use steps which tells users to predict endometrial or ovarian cancer in the sample, amounts to no more than an "instruction to apply the natural law". This is no more than a mental step. Even if the step requires something more such as to verbalize the discovery of the natural law, this mere verbalization is not an application of the law of nature to a new and useful end. The preamble does not require the process user to do anything in light of the correlation. The preamble fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.”
Question 2A Prong II
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 the claim recites determining methylation of ZSCAN12, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception.
Claims 1, 4-17 have been amended to require administering a therapeutic treatment “when” hypermethylation is detected. This step is conditional and “when” hypermethylation is not determined, no treatment is required. Even more, the treatment is not particular. The treatments recited encompasses all treatments are not particular to the judicial exception.
Question 2B
The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons:
The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope.
The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The measuring methylation status is mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the methylation of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the markers through whatever known processes they wish to use.
The step of determining the methylation was well known in the art at the time the invention was made. The prior art teaches that methylation analysis using commercially available biochips and arrays that comprise the claimed genes. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any methylation analysis to determine the methylation status. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed.
Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known. Specifically, the specification teaches SEQ ID NO: 2 is probe cg25060829 on the Illumina 450K BeadChip.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Response to Arguments
The response traverses the rejection. The response asserts the claim now recites a therapeutic treatment step which integrates the judicial exception into a practical application and is thus patent eligible. This argument has been considered but is not convincing because the administration step is conditional and “when” hypermethylation is not detected, no administration is required.
Moreover, as discussed above, the treatment is not particular and is general in nature as it encompasses all treatments. Thus for the reasons above and those already of record, the rejection is maintained.
Claim Rejections - 35 USC § 112-Scope of Enablement
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-2, 4-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of detecting SEQ ID NO: 2 in human subjects to detecting methylation, does not reasonably provide enablement for a method for detecting methylation in ZSCAN12. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The nature of the invention and breadth of claims
Claims are drawn to method for detecting and treating an endometrial carcinoma by determining methylation status of one or more CpG dinucleotides in ZSCAN12, comparing the methylation status with a reference methylation state and administering a therapeutic treatment to the subject when hypermethylation is detected.
Claims 9-14 are further directed to monitoring the impact of a therapeutic treatment, early diagnosis of a subject, assessing risk of relapse, assessing molecular residual disease, assessing therapeutic resistance in patients with metastasis.
The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The unpredictability of the art and the state of the prior art
The art teaches methylation analysis of ZSCAN12 in swabs from symptomatic patients with endometrial cancer (see Herzog et al. (J. or Clinical Oncology, Vol. 40, pages 3828-3838, 2022)). Figure 1 illustrates cg25060829 in ZSCAN12 and demonstrates a single methylation peak at cg25060829 but no additional methylated markers in the region.
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Guidance in the Specification.
The specification provides no evidence that the broad scope of the claims are enabled. The specification teaches SEQ ID NO: 2 is 87 nucleotides in length. The specification states this is the cg25060829 probe on the Illumina 450K array.
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The post filing date art illustrates differentially expression only at the single cg25060829 methylation site.
The specification teaches the probe is hypermethylated in uterine corpus endometrial cancers, and hypomethylated in ovarian cancer.
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The guidance provided by the specification amounts to an invitation for the skilled artisan to try and follow the disclosed instructions to make and use the claimed invention.
Quantity of Experimentation
The quantity of experimentation in this area is extremely large since there is significant number of parameters which would have to be studied to enable the use of any CpG site in ZSCAN12 for detecting or monitoring endometrial or ovarian cancer. The post filing date art of Hertzog illustrates differentially expression only at the single cg25060829 methylation site. It would require further unpredictable experimentation to analyze each of the CpG sites in ZSCAN12 and determine whether they are differentially methylated in endometrial or ovarian cancers.
The specification does not provide any support for monitoring the impact of a therapeutic treatment, assessing risk of relapse, assessing molecular residual disease, assessing therapeutic resistance in patients with metastasis. There is no assessment of when methylation may be used to detect diagnosis, whether residual disease or therapeutic resistance may be detected. The specification teaches that it is not predictable that methylation is associated with the same phenotype in the same manner. Figure 2 illustrates hypermethylation in endometrial cancers and hypomethylation in ovarian cancers. Therefore, the skilled artisan would be required to perform further unpredictable and undue experimentation to determine which phenotypes are associated with hyper and hypo methylation since the specification provides no guidance.
This would require significant inventive effort, with each of the many intervening steps, upon effective reduction to practice, not providing any guarantee of success in the succeeding steps.
Level of Skill in the Art
The level of skill in the art is deemed to be high.
Conclusion
Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of a working example and the negative teachings in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
Response to Arguments
The response traverses the rejection. The response asserts DNA methylation typically affects a stretch of CpG dinucleotides within a gene rather than an isolated site. This argument is merely an argument and is not supported by evidence. The art teaches not all CpG in a gene are similarly methylated (see Herzog).
The response argues that Example 1 demonstrates that neighbor positions in the Illumina HM450 array are detected as consistently hypermethylated in endometrial carcinoma. This argument has been reviewed but is not considered persuasive. Example 1 does not provide the results to the analysis but merely considered performing the analysis. The specification is not clear on which CpG sites were analyzed and which neighboring CpG sites were found to be similarly associated. The specification does not teach which CpG sites are methylated. It would be unpredictable and undue experimentation to determine if other CpG sites are methylated and which sites are methylated.
The response argues Herzog is not prior art. This argument has been considered. The Examiner agrees Herzog is not prior art. However, if a publication demonstrates that those of ordinary skill in the art would find a particular invention was not enabled years after the filing date, it could be evidence that the claimed invention was not possible at the time of filing. See MPEP 2164.05(a).
The response argues that the fact that a single peak, over a narrow region in the ZSCAN12 region showed differential methylation in the HM450 array in Herzog does not mean methylation is limited to that single site. This argument has been reviewed but is not persuasive. The evidence of record, namely Herzog, teaches the single peak is the only methylated site. Applicant has provided no evidence that the skilled artisan would have determined additional hypermethylation of CpG sites in the ZSCAN12 gene would be indicative of the patient having endometrial cancer. Applicant may wish to submit evidence of additional CpG sites in the ZSCAN12 gene that are hypermethylated with evidence.
Thus for the reasons above and those already of record, the rejection is maintained.
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.
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 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.
Claim(s) 1, 4-5, 7-8, 10, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (BMC Genomics, Vol. 15, No. 868, 2014).
The specification teaches SEQ ID NO: 2 is a probe on the Illumina 450K methylation array.
Zhang teaches methods for diagnosing endometrial cancer using CpG methylation. Zhang teaches analyzing DNA methylation microarray data from an Infinium Human Methylation 450K BeadChip. Zhang teaches TCGA Infinium 450K data was obtained (page 16, col. 2). Thus, Zhang inherently teaches detecting and determining methylation of ZSCAN12 gene in endometrial cancer (para 119).
With respect to Claim 7, Zhang teaches genomic DNAs were extracted from the tumor tissues (para 126).
With respect to Claims 8 and 15, the claim merely limits the methylation detection and does not limit the level of expression limitation.
With respect to Claims 10 the claims are merely directed to intended use. The claim does not require any methods steps in addition to the detecting level of methylation. The method of Zhang may be used for any of these uses.
Response to Arguments
The response traverses the rejection. The response asserts Zhang does not identify, disclose or correlate methylation of ZSCAN12 with endometrial cancer and ZSCAN12 is not mentioned in these references. This argument has been considered but is not convincing because the reference inherently teaches each limitation required by the instant claim. First, Zhang teaches determining the methylation status of one or more CpG dinucleotides in ZSCAN12. Zhang performs analysis on the 450K methylation array which comprises probes for CpG sites in ZSCAN12. Second, Zhang teaches calculating the beta value which is a comparison to a reference value. Thus, Zhang teaches comparing the determined methylation status with a reference methylation state. The statement that “wherein hypermethylation is indicative of the presence of endometrial carcinoma is a statement of intended use and is not an active method step. The instant claims are conditional and do not require a therapeutic treatment unless hypermethylation is detected. Therefore, Zhang teaches each limitation of the claimed invention. Thus, for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
June 14, 2026
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