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 .
The claims dated 6/17/2026 are under consideration.
The amendments and arguments presented in the papers filed 6/17/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 2/17/2026 listed below have been reconsidered as indicated.
a) The amendments to the specification addressing hyperlinks and trade names or marks are acknowledged.
b) The objection of claim 18 is withdrawn in view of the amendments to the claim.
c) The rejection of claim 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in view of the amendments to the claim limiting the type of sample to a serum sample.
d) The rejection of claim 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of the amendments to claim 18 requiring determining the express level of at least the recited miRNAs before and after ovarian cancer treatment.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Election/Restrictions
Applicant elected with traverse Group III, claim 18, in the reply filed on 11/24/2025.
Claims 1, 3-8, 14-15 and 21-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/24/2025.
Priority
The present application is a 371 national stage entry of PCT/PL21/50079 (filed 11/11/2021) and claim foreign priority to POLAND P.435967 (filed 11/12/2020).
An English translation of the foreign priority document has not been received.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
It is noted that applicant filed a Sequence Listing on 6/17/2026. The following requirement has been maintained. The Sequence Listing dated 6/17/2026 is defective. Applicant is directed to the “Sequence Listing in Computer Readable Format is Defective” document dated 6/17/2026 for additional information.
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because the specification discloses nucleotide sequence at least on page 28.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Claim Interpretation
Claim 18 states “wherein the comparison provides an indicator of the subject's response to the ovarian cancer treatment for adjustment of the ovarian cancer treatment”. The recitation states a result that flows from making the comparison. It is noted the claim does not require an active method step of “indicating the subject’s response to the ovarian cancer treatment” and/or “adjusting the ovarian cancer treatment”.
It is noted the claim does require an active method step of “determining levels of the miRNA biomarkers” both before and after ovarian cancer treatment.
Claim 18 as amended recites two “wherein” clauses stating:
wherein (i) an increase in the expression level of miR-1246 in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-1246 in the sample from the subject before the ovarian cancer treatment and (ii) a decrease in the expression level of miR-150-5p in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-150-5p in the sample from the subject before the ovarian cancer treatment indicate an increased presence of ovarian cancer in the subject; or
wherein (i) a decrease in the expression level of miR-1246 in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-1246 in the sample from the subject before the ovarian cancer treatment and (ii) an increase in the expression level of miR-150-5p in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-150-5p in the sample from the subject before the ovarian cancer treatment indicate a decreased presence of ovarian cancer in the subject.
The claim provides information that may be used in the context of the “comparing” step or that may be used for “indicating” the status of the ovarian cancer in the subject. However, “wherein” clause does not limit any of the positively recited, active method steps of the claim. The clauses are interpreted as not limiting the scope of the claim as indicating a decrease or increase in the presence of ovarian cancer is not an element required by the claimed active method steps.
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.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
Claim 18 recites a series of steps and therefore is a process.
The claim(s) recite(s):
“determining the expression level of a panel of two miRNA biomarkers: miR-1246 and miR-150-5p in a sample from a subject before and after the ovarian cancer treatment”;
“comparing the levels determined in step i) with the expression levels of miR-1246 and miR-150-5p in the subject before ovarian cancer treatment”; and
“the comparison provides an indicator of the subject's response to the ovarian cancer treatment for adjustment of the ovarian cancer treatment”.
The “determining” step broadly encompasses an abstract idea in view of the specification. The specification describes “normalization” or analysis, manipulating or processing of raw data as being how expression levels are determined. See p. 4 and 5. The “normalization” process is based on a formula, i.e., a mathematical formula, which is an abstract idea.
The “comparing” step broadly encompasses comparing four to six data points. This limited amount of data may be compared purely in the human mind and thus encompasses an abstract idea.
The statement regarding what the “comparison provides” broadly sets forth a natural correlation between the levels of the miRNA biomarkers and the subject’s response to treatment.
The claim as amended sets forth two “wherein” clauses at the end of the claim that set forth a natural relationship between the level of miRNA determined and the presence of ovarian cancer. This information is a natural phenomenon.
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions as they broadly encompass data gathering steps. While claim 18 further comprises “treating the subject based on the indicator of the subject's response to the ovarian cancer treatment”, the treating is not particular in any manner. The step is recited at a high level of generality such that it amounts to instructions “to apply” the judicial exceptions. Furthermore, the step is premised on the “indicator”; however, the claim does not require any active method steps of “indicating the subject’s response to the ovarian cancer treatment” and/or “adjusting the ovarian cancer treatment”. Thus, there is no nexus between the above judicial exceptions and the treating step.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of techniques that are well-known and used in a conventional manner as described on pages 10, 12 and 15 of the instant specification.
Examiner’s response to the traversal of the 101 rejection
The Remarks argue the claim, as amended, recites a method of treatment which recites a patent-eligible practical application and claim 18 as amended is not directed to an abstract idea, but instead recites a specific, concrete method of monitoring and treating a disease. The Remarks argue the ordered combination of steps - (i) determining specific molecular markers from a physical serum sample taken before and after treatment; (ii) comparing these levels based on a specific directional change to obtain an indicator; and (iii) actively treating the subject based on that indicator - integrate any underlying concepts into a practical application. The Remarks further argue the claim does not pre-empt the use of the recited biomarkers, but rather claims a specific application of using them in a multi-step treatment process and this constitutes "significantly more" than a judicial exception itself by tying the diagnostic correlation to a specific therapeutic action, thereby transforming it into a patent-eligible method. See p. 11 of 15.
The arguments have been fully considered but are not persuasive. First, it is noted that the steps forming the basis of the arguments, i.e.,
determining specific molecular markers from a physical serum sample taken before and after treatment;
(ii) comparing these levels based on a specific directional change to obtain an indicator; and
(iii) actively treating the subject based on that indicator
are different from those recited in the claimed method. The “comparing” step does not actively require observing any “specific directional change”. Furthermore, the intended use of the “comparing” step which is to provide an “indicator of the subject’s response to the ovarian cancer treatment”, is distinct from the information provided in the final two “wherein” clauses which describe “increased” or “decreased” presence of ovarian cancer.
Second, the positively recited, active methods steps do not involve making any “determinations”, “indications”, etc., regarding the patient’s response to ovarian cancer treatment or how to particularly treat the patient. The “treating” step is recited at a high level of generality and basically instructs one to act in the way a doctor would based on whether or not a presence of ovarian cancer is observed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The following are new rejections necessitated by the amendments to the claims.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 as amended requires “comparing the levels determined in step i) with the expression levels…before ovarian cancer treatment”. Step i) requires determining expression levels in a sample “before and after the ovarian cancer treatment”. The instant specification does not support comparing expression levels before ovarian cancer treatment with expression levels before ovarian cancer treatment or how that comparison provides any useful information. The instant specification supports comparing expression levels before treatment with expression levels after treatment.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Todeschini (Cancer Letters. 2017. 388:320-327 and Supplementary Materials) and Lodes (WO 2010/098862 A2)
Regarding claim 18, Todeschini teaches determining the levels of miRNAs prior to ovarian cancer treatment in serum samples (p. 321, patients, and miRNA profiling by microarray). The microarray includes reagents for detecting hsa-miR-1246 and hsa-miR-150-5p (Table S2.1 and S3.1).
Todeschini is sufficient to teach determining the expression level of hsa-miR-1246 and hsa-miR-150-5p in serum samples as embraced by part (i) of the claim.
Lodes further teaches the use of miRNA expression patterns as a biomarker to monitor the effect of therapy on cancer progression (p. 5 to 6).
It would have been prima facie obvious to the ordinary artisan at the time of filing to have used the miRNAs assays of Todeschini to monitor in serum whether HGSOC cells are present over the course of ovarian cancer treatment. For example, one would monitor the miRNA levels prior to treatment to have an established baseline regarding the ovarian tumor miRNA levels. By measuring the levels of miRNAs after the start of treatment, one would be able to gauge the progression of the ovarian cancer. For example, if the levels changed and looked more like benign or normal tissue, one would conclude the treatment was working or had worked. Alternatively, if the levels did not change, one would reasonably conclude the treatment was not working as ovarian tumor cells were still present. Based on whether or not ovarian tumor cells are present, one would be able to adjust the treatment accordingly.
As described in the above claim interpretation section, the claim includes a number of intended results or uses and “wherein” clauses that provide information regarding miRNA levels. However, this claim language does not further limit how the active methods of “determining”, “comparing” and “treating” are carried out and do not impact the scope of the claims.
Examiner’s response to the traversal of the rejection over Todeschini
The Remarks argue a person of ordinary skill in the art (POSA) without the benefit of impermissible hindsight reconstruction would not have been motivated to combine the cited references in order to arrive at the claimed invention, nor would they have had any reasonable expectation of success. See p. 12 of 15.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The above rejections are made over the broadest reasonable interpretation as established in this office action.
The Remarks argue Todeschini discloses differential expression of a long list of microRNAs, including inter alia miR-1246 and miR-150-5p, in ovarian cancer tissue - not serum (Todeschini, Supplementary Table S3.1). See p. 12-13 of 15.
The argument is not persuasive as Todeschini teaches determining the expression level of miRNA in serum (Table S2.1) and making comparisons using the data. The claim is not limited to determining the expression levels of only the two recited miRNAs and broadly encompasses determining the expression level of any number of miRNAs as long as the two recited are included. The reagents and assays of Todeschnini as sufficient to determine the expression levels of miR-1246 and miR-150-5p.
The Remarks argue the prior art, including Todeschini, teaches that miRNA expression trends are unpredictable and even yield opposite results when comparing between tissue and serum. See p. 13 of 15.
The arguments have been fully considered but are not persuasive. The claim is not limited to measuring only the two recited miRNA or reaching any type of indication based solely on the expression level of miR-1246 and miR-150-5p.
The Remarks argue a POSA would be led away from using a tissue-based marker for a serum-based monitoring application, and certainly would eliminate any reasonable expectation of success. The Remarks further argue Todeschini's disclosure is a broad concept that does not suggest selecting the specific pair of miR-1246 and miR-150-5p for monitoring ovarian cancer in serum and does not render the claimed method obvious. See p. 13 of 15.
The arguments have been fully considered. The claim does not require only determining the expression level of miR-1246 and miR-150-5p and does not require observing any specific levels of the mRNAs. The claim does not require making any indications based on the determined levels. The claim broadly encompasses simply making a comparison between miRNA levels determined before and after ovarian cancer treatment. Thus, the arguments are not commensurate in scope with the invention as broadly claimed presently.
The Remarks argue Lodes teaches the general idea of using miRNA patterns to monitor cancer therapy, it provides no specific guidance for ovarian cancer and Lodes's disclosure is a broad concept that fails to cure the deficiencies of Todeschini and does not suggest selecting the specific pair of miR-1246 and miR-150-5p for monitoring ovarian cancer in serum. See p. 13 of 15.
The arguments have been fully considered. The arguments are not commensurate in scope with the invention as broadly claimed presently. As noted previously, the claim does not require making any determination solely, based on any determined levels of miR-1246 and miR-150-5p. Any reference to an “indication” or the relationship between miRNA levels and ovarian cancer are in recitations of intended uses present in “wherein” clauses that do not impose any meaningful limitations on how the active methods steps are carried out.
The Remarks argue the combined references fail to teach or suggest the core requirements of the claimed invention i.e., the specific indicator of treatment response and Applicant demonstrated for the first time that an increase in miR-1246 and a decrease in miR-150-5p in serum over the course of treatment is indicative of an increased presence of ovarian cancer and thereby provides a critical indicator of the subject's response. The Remarks further argue these specific directional changes are the linchpin of the claimed method and are absent from the prior art. The Remarks reiterate a POSA, starting from Todeschini and Lodes, would not have been motivated to select this specific pair of markers for a serum-based assay and would have had no reasonable expectation of discovering this particular inverse relationship as a reliable indicator for monitoring ovarian cancer treatment. The Remarks argue the claimed method as a whole, in the absence of hindsight bias, would not have been obvious at the time of filing. See p. 13 of 15.
The arguments have been fully considered but are not persuasive. The claims do not require any active methods steps that reach any sort of determination regarding ovarian cancer in a subject as noted previously in the office. The arguments are not commensurate in scope with the broad method claimed presently.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning.
The Remarks argue each of the issues raised by the Examiner have been addressed by the amendments and remarks provided herewith. The Remarks argue the amendments to the claims clarify that: (1) expression levels are determined both "before and after" treatment, providing proper antecedent basis for the
comparison; (2) the method is performed on a "serum sample," conforming
the claim scope to the enabling disclosure; and (3) the indicator of response is based on the specific, inventive finding that an increase in miR-1246 and a decrease in miR-150-5p over the course of treatment indicates an increased presence of ovarian cancer and vice versa, distinguishing the claim from the prior art. See p. 14 of 15.
The arguments have been fully considered but are not persuasive because they are not commensurate in scope with the broad method as presently claims.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elias (eLife. 2017. 6:e28932, 28 pages and Supplementary File 5).
The following are new rejections necessitated by the amendments to the claims.
Regarding claim 18, Elias teaches determining the expression level of miR-1246 and miR-150-5p in serum samples (p. 15, Study subjects for model development) using either sequencing (p. 16, Next generation sequencing) or qPCR (p. 17, qPCR).
Elias teaches samples from pre- and post- treatment with surgery were analyzed (p. 17, Comparison of preoperative and postoperative samples; and p. 8).
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Elias further teaches that in cancer versus non-cancerous serum that miR-1246 is increased and miR-150-5p is decreased (Supplementary File 5). The data from Supplementary File 5 is reproduced below:
Elias teaches comparing the expression level before and after treatment (p. 17, Comparison of preoperative and postoperative samples; and p. 8). It is noted that the “comparing” step simply requires comparing expression levels. While the step includes a “wherein” clause stating, “wherein the comparison provides an indicator of the subject's response to the ovarian cancer treatment for adjustment of the ovarian cancer treatment”, the clause states a result that flows from making the comparison and is considered an intended use of the comparison step. It is noted the claim does not require an active method step of “indicating the subject’s response to the ovarian cancer treatment” and/or “adjusting the ovarian cancer treatment”. The clause does not limit the manner in which the “comparing” is carried out. Thus, the comparison of Elias satisfies the elements required by the active method step of “comparing”.
The claim as amended recites two “wherein” clauses stating:
wherein (i) an increase in the expression level of miR-1246 in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-1246 in the sample from the subject before the ovarian cancer treatment and (ii) a decrease in the expression level of miR-150-5p in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-150-5p in the sample from the subject before the ovarian cancer treatment indicate an increased presence of ovarian cancer in the subject; or
wherein (i) a decrease in the expression level of miR-1246 in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-1246 in the sample from the subject before the ovarian cancer treatment and (ii) an increase in the expression level of miR-150-5p in the sample from the subject after the ovarian cancer treatment relative to the expression level of miR-150-5p in the sample from the subject before the ovarian cancer treatment indicate a decreased presence of ovarian cancer in the subject.
The claims provide information that may be used in the context of the “comparing” step or that may be used for “indicating” the status of the ovarian cancer in the subject. However, “wherein” clause does not limit any of the positively recited, active method steps of the claim. The clauses are interpreted as not limiting the scope of the claim as indicating a decrease or increase in the presence of ovarian cancer is not an element required by the claimed active method steps.
While Elias teaches the above methods, Elias does not specifically teach treating a subject based on the observed miRNA levels. However, it would have been prima facie obvious to the ordinary artisan to have used miRNA levels to monitor whether or not the subject’s profile was like a normal serum sample or like a serum sample from a subject with ovarian cancer. For example, one may use the model of Elias to classify a patient based on changes in the miRNA levels over time. Further, if a patient post-surgery is determined to have a miRNA profile indicating the presence of ovarian cancer, it would have been prima facie obvious to have treated the patient for the ovarian cancer, i.e., additional surgery, chemotherapy, etc. Alternative, if a patient post-surgery is determined to have a miRNA profile indicating the absence or decrease in ovarian cancer, it would have been obvious to treat the patient by continuing to monitor the patient to see whether there are any signs of cancer recurrences, i.e., an increase in ovarian cancer.
Conclusion
No claims allowed.
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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST 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, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682
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