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 April 27, 2026. Currently, claims 1-20 are pending. Claims 2-4, 8-13, 19-20 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election without traverse of the combination of 13 biomarkers, claims 1, 5-7, 14-20 in the paper filed April 27, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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It is noted that a translation of the foreign document has not been received.
Drawings
The drawings are acceptable.
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, 5-7, 14-18 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 “a method for treating breast cancer by administering a treatment “appropriate for treating breast cancer” wherein prior to administration, a signature score was produced from normalized levels of….and had been determined to be above a reference signature score”.
Claim 1 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of a signature score which was produced from normalized levels and “had been determined to be above a reference signature score”) and a law of nature/natural phenomenon (i.e. the natural correlation between the signature score and breast cancer).
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 a signature score was produced from normalized levels and had been determined to be above a reference signature score. This is a recitation of a mathematical calculation. Producing a signature score from normalized levels of biomarkers is a mathematical concept and mental process. Thus, the signature that was produced from normalized levels that was determined to be above a reference signature score constitutes an abstract process idea.
Claim 1 further recites a comparison between the signature score and a reference signature score 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 a signature score produced from normalized levels of biomarkers and breast cancer is a law of nature/natural phenomenon. The "assessing" step which tells users of the process to administer a treatment in the sample, amounts to no more than an "instruction to apply the natural law". This assessing step 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 "assessing" step does not require the process user to do anything in light of the correlation. The "assessing" step 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. The sole administration a treatment step appropriate for treating breast cancer is not particular and is general in nature. There is no particular application of the judicial exceptions.
Accordingly, the claims are directed to judicial exceptions.
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 expression levels of genes are 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 biomarkers 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 essentially tells users to determine the markers through whatever known processes they wish to use.
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.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 15 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 pre-AIA the applicant regards as the invention.
Regarding claim 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 5-7, 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gehrmann et al. (US 2014/0228241, August 14, 2014).
Gehrmann teaches a method for predicting the response to chemotherapy in a patient suffering from or at risk of developing recurrent breast cancer. Gehrmann teaches analysis of Affymetrix HG-U133A gene expression data sets. The Affymetrix HG-U133A array inherently comprises each of the elected genes. Therefore, Gehrmann inherently teaches determining a signature score for each of the genes in the combination, and normalizing the data (para 81). Gehrmann teaches a high score value indicates an increased likelihood of response after neoadjuvant chemotherapy treatment, and a low score value indicates a decreased likelihood of developing a pathological complete response after neoadjuvant treatment. Gehrmann teaches that a high score indicates that the patient is a high risk patient who will benefit from a more aggressive therapy, e.g. cytotoxic chemotherapy (para 92).
With respect to Claim 14, Gehrmann teaches sample includes blood, serum, plasma (para 33).
With respect to Claim 15, Gehrmann teaches Affymetrix U-133 arrays or protein levels may be used to measure expression levels (para 90).
With respect to Claim 16, Gehrmann teaches the levels of biomarkers are normalized against reference genes (para 97).
With respect to Claim 18, Gehrmann teaches combining the expression levels may be accomplished by multiplying each expression level with a defined and specified coefficient and summing up such products to yield a score (para 36).
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou (US 2020/0370122, November 26, 2020) Zhou teaches predicting breast cancer outcome by determining the expression levels of a plurality of biomarkers to generate and derive an index which can be used as an indicator predictive of cancer patient outcome (abstract). Zhou teaches analysis of expression and classifying different subtypes (see Figure 1-2). Zhou teaches obtaining expression values from Affymetrix gene expression data in a format of CEL files that were processed using Robust Multi-chip Average and merged into a dataset and standardized (para 56). This data comprised the elected biomarkers, as Affymetrix array data comprises analysis of each of the claimed combination. Zhou teaches the expression product is determined by normalization to the level of reference RNA transcripts (para 25). Zhou teaches the analysis is used to develop a treatment strategy for breast cancer patients. Zhou teaches the information will be used for determining poor and worse prognosis and treatment decisions (para 16, 18-19).
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.
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 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 24, 2026
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