DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This action is in response to the papers filed March 12, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicant's amendments. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
Applicant’s election without traverse of Group I, traverse cervical squamous cell carcinoma and endocervical adenocarcinoma, and the combination of PCED1B-AS1, RP11-291B21.2 and AC092580.4 is reiterated for the record.
Claims 1, 3-4, 6-10, and 13-15 are currently pending.
Claims 3, 4, and 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter (either a nonelected invention or nonelected species), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20, 2025.
Applicants are reminded that for any amendment being filed in response to a restriction or election of species requirement and any subsequent amendment, any claims which are non elected must have the status identifier (withdrawn). In response to this Office Action Applicants should indicate that claims 3 and 4 are now withdrawn as they read on non-elected combinations of lnrRNAs.
Claim Objections
3. Claim 1 is objected to because of the following informalities: the claim recites “identifying of a lncRNA signature”. This is grammatically incorrect. Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. 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, 6 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite abstract ideas. In particular they recite mental processes because they cover concepts performed in the human mind, including observations, evaluation, judgment, and opinions.
Claim 1 recites a step of “identifying” a lncRNA signature of PCED1B-AS1, RP11-291B21.2 and AC092580.4 in a cancer patient’s tumor tissue. Neither the specification nor the claims set forth a limiting definition for “identifying” and the claims do not set forth how this step is accomplished. In the instant case it is not clear that “identifying” requires performing any “wet” laboratory steps. The broadest reasonable interpretation of the “identifying” step is that it may be accomplished by a mental processes. For example, one may “identify” a lncRNA signature by reading a laboratory report for the patient.
The instant claims recite a law of nature.
Claim 15 recite a correlation between the lncRNA signature (PCED1B-AS1, RP11-291B21.2 and AC092580.4) and overall survival. 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.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Claim 1 recites a step of “administering” a cancer treatment. It is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. However the treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exceptions. Here the administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the judicial exceptions into a practical application.
The claims do not recite any other steps in addition to the judicial exceptions that integrate the judicial exceptions into a practical application.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
The claims do not recite any other steps in addition to the judicial exceptions that provide an inventive concept.
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.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
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 the reasons set forth above the claims are not directed to patent eligible subject matter.
Response To Arguments
5. In the response the Applicants traversed the rejection under 35 101. They argue that the rejection should be withdrawn because they have amended Claim 1 to include a treatment step and to specify which patients are treated.
The amendment has been fully considered but does not overcome the rejection. Claim 1 recites a step of “administering” a cancer treatment. It is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. However the treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exceptions. Here the administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the judicial exceptions into a practical application. Claims 1, 3, 4, 6, and 15 remain rejected. Claim 13 is no longer rejected because it recites specific types a treatment. Claim 14 is no longer rejected because states the identifying step is done by performing PCR.
Claim Rejections - 35 USC § 112(b)
6. 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.
Claim 15 is 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 15 is rejected over the recitations of “better overall survival (overall survival (HR) less than 1)” and “worse overall survival (overall survival (HR) greater than 1)”. The claim is considered indefinite because it contains information in parentheses. Parentheticals make the claims indefinite because it is unclear whether the information in the parentheses has the same, less, or more weight as the rest of the claim language. This rejection may be overcome by deleting the information in parentheses.
Claim 15 recites that “the cancer treatment is administered when the lncRNA signature predicts worse overall survival”. The recitation of “when” makes it sound like the administering step is conditional and the treatment is only administered when overall survival is worse. This recitation is confusing when read with claim 1 because claim 1 requires administering the cancer treatment to ALL patients regardless of their predicted overall survival. Therefore it’s not clear how this limitation is further limiting. Clarification is required.
Claim Rejections - 35 USC § 103
7. 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, 6, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Knudsen (Breast Cancer Res Treat (2012) 133:1009-1024) in view of Trayes (Am Fam Physician 2021;104(2):171-178).
Regarding Claims 1 and 6 Knudsen teaches that DCIS and IBC samples were obtained from a tumor bank. Total RNA was extracted and amplified to produce cDNA. The cDNA was then hybridized to the Affymetrix Human Exon 1.0 ST GeneChip arrays (pages 1010-1011). It is noted that it is a property of this array that it contains probes for detecting PCED1B-AS1 (ENSG00000247774), RP11-291B21.2 (ENSG00000256039), and AC092580.4 (ENSG00000235576) (See OA Appendix). It is noted that the claims recite a signature but do not require the lncRNA’s to be present, absent, increased, or decreased in the signature. This rejection is based on a broad interpretation of the claims that by detecting these lncRNA’s, Knudsen identified a lncRNA signature of PCED1B-AS1, RP11-291B21.2 and AC092580.4 in a cancer patients tumor tissue, wherein the cancer is invasive breast cancer.
Knudsen does not teach a method further comprising administering a cancer treatment to the patient (clm 1). Knudsen does not teach a method wherein the cancer treatment is chemotherapy, radiation, or immunotherapy (clm 13).
However Trayes teaches ductal carcinoma in situ is treated with lumpectomy and radiation or with mastectomy. If ductal carcinoma in situ is estrogen receptor–positive, patients may also receive endocrine therapy. Early invasive stages (I, IIa, IIb) and locally advanced stages (IIIa, IIIb, IIIc) are nonmetastatic and have three treatment phases. The preoperative phase uses systemic endocrine or immunotherapies when tumors express estrogen, progesterone, or ERBB2 receptors. Preoperative chemotherapy may also be used and is the only option when tumors have none of those three receptors. There are two options for the surgical phase with similar survival rates; a lumpectomy with radiation if the tumor can be excised completely with good cosmetic results, or a mastectomy. Sentinel lymph node biopsy is also performed when there is suspected nodal disease. The postoperative phase includes radiation, endocrine therapy, immunotherapy, and chemotherapy. Postmenopausal women should also be offered postoperative bisphosphonates (abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Knudsen by further administering a cancer treatment to the cancer patients as suggested by Trayes. One of skill in the art would have been motivated to administer chemotherapy, radiation, or immunotherapy to the cancer patients because as demonstrated by Trayes these were the conventional therapies given at the time to treat DCIS and IBC.
9. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng 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.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
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