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 .
Status of the Claims
Claims 47-66 are pending.
Claim 66 is withdrawn.
Claims 47-65 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group 1 and mRNA RP11-452L6.1 and peptide RP11-452L6.1 in the reply filed on 3 August 2026 is acknowledged.
Claim 66 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3 August 2026.
Claim Rejections - 35 USC § 112 - Enablement
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.
Claims 49, 50, 57, and 60-65 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are broadly drawn to a method of diagnosing or determining a prognosis of breast cancer in a subject using the biomarker RP11-452L6.1.
Factors to be considered
In determining whether a disclosure meets the enablement requirement of 35 USC § 112, first paragraph, factors have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988).
Wands states on 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 skills of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims."
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make or use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided.
The Nature of the Invention
The nature of the presently claimed invention is determining a level of RP11-452L6.1 in a biological sample from the subject and making a diagnosis or determination that the subject does or does not have breast cancer. Such an invention has potential use in the art for diagnosing breast cancer, however, the nature of such an invention is within the broad genera of using a biological sample to make a diagnostic determination, and, as shown below, Applicants' invention, as claimed, is not enabled due to problems with the complexity, unpredictability, and unknown correlation between levels of RP11-452L6.1 as an indicator in the biological sample, lack of specific guidance, state of the art, and the amount of experimentation required to successfully practice the claimed invention.
The Breadth of the Claims
The instant claims are drawn to the use of a biological sample to determine a level of RP11-452L6.1 in the biological sample and diagnose or determine if the subject has breast cancer. The aspects considered broad is the correlation between the biomarker and the diagnosis. As will be shown below, this aspect is not enabled.
Predictability and State of the Art
The art is unpredictable. With respect to diagnosis of cancer by detecting levels of RP11-452l6.1, the art does not show any correlation with the biomarker in a subject and if they will develop breast cancer.
There is nothing in the specification to indicate any level of RP11-452L6.1 and breast cancer. Applicant points to studies completed by other researchers that show a comparison of levels of biomarkers in patients with breast cancer and those that do not have breast cancer. That data is not provided in the specification and even if it was it does not prove causation. There is nothing in the specification to show that applicant has detected this marker in a subject that later developed breast cancer. There is nothing in the specification to show that RP11-452L6.1 was used to diagnose breast cancer.
The prior art does not show any correlation between RP11-452L6.1 and breast cancer.
Hence, from the nature of the invention and the state of the art, the Artisan would not reasonably predict that determining the level of RP11-452L6.1 in a subject would be predictive of developing breast cancer or diagnosing breast cancer.
The Amount of Direction or Guidance/The Existence of Working Examples
The specification does not provide any guidance regarding diagnosing or determining if a subject has breast cancer or could develop breast cancer.
The specification provides cites to studies that detected biomarkers in patients with breast cancer and patients that did not have breast cancer.
Amount of Experimentation Necessary
There would be a large and prohibitive amount of experimentation required to make and use the claimed invention in the full scope as encompassed by the claims. One would have to perform a large scale study detecting RP11-452L6.1 in patients that do not have breast cancer and track them to see if they develop breast cancer. The fact that breast cancer patients in a study showed a difference in biomarkers is not determinative a diagnosis.
Conclusion
In conclusion, the instant specification is not enabling because one cannot follow the guidance presented therein and practice the claimed methods without first making a substantial inventive contribution. As such, claims 49, 50, 57, and 60-65 are not enabled, because there would be an undue amount of experimentation required to make and use the invention as claimed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 49, 50, and 60 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant elected RP11-452L6.1, which is a long non-coding RNA. Applicant has identified RP11-452L6.1 an mRNA and as a peptide and it is neither. It is not clear from the claims what applicant is intending to claim, however, they will be interpreted to read on a biomarker and not an mRNA or peptide as a long non-coding RNA is not an mRNA and is non-coding, therefore does not produce a peptide.
Claim 51 recites the limitation "(iii)" in the third line. There is insufficient antecedent basis for this limitation in the claim. Claim 47 does not recite an (f)(iii).
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 47-65 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon and an abstract idea) without significantly more. The claim(s) recite(s) determining a method of diagnosing or determining a prognosis of breast cancer in a subject. This judicial exception is not integrated into a practical application based on the reasoning below:
The unpatentability of laws of nature and abstract ideas was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S., (2010) (slip op., at 5). “Phenomena 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).
Additionally, the unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Inti, 134 S. Ct. 2347, 2354 (2014).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claims are directed to methods.
Step 2A, prong 1. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, where the claims recite a step of diagnosing or determining if a subject has breast cancer from expression levels of biomarkers, they encompass the mental comparison of data and the correlation of data and information to reach a conclusion. Further, the diagnosis is based on a law of nature or natural phenomenon because it is based on a level of a biomarker already occurring in the subject.
Step 2A, prong 2. Does the claim recite additional elements that integrate the exception into a practical application? No, the judicial exceptions to which the claims are directed are not integrated into a practical application because the rejected claims do not require any particular practical steps related to the determining a biomarker level and predicting response to a treatment. The claims recite using a computer executable program, however reciting a generic computer does not overcome an eligibility rejection. The claims do not recite anything other than a computer executable program.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims only recite diagnosis or determining breast cancer.
For these reasons, the claims are rejected under USC 35 section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 47, 48, 51-56, 58, and 59 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosner et al. (US 2016/0078167 A1).
Regarding claim 47 and 58, Rosner et al. teach a method of calculating a prognosis score of a breast cancer patient. (claims 1). Rosner et al. teach measuring the level of expression in a sample with at least four biomarkers and comparing the level of expression or activity of each biomarker to a reference expression level or activity and calculating a prognosis score using a computer algorithm. (claim 1). Claim 4 recites calculating a prognosis score with thresholds.
Regarding claim 48, Rosner teach that the markers are genes. (for example claim 4).
Regarding claims 51-53, Rosner teach overexpression refers to biomarkers that are upregulated in cancer cells compared to non-cancer cells. [0064]. Rosner teach that overexpression can be 10% to 90% more than a normal cell or a cancer cell that is not associated with the worst or poorest prognosis. [0064]. Rosner further states that can be underexpression. [0122-124].
Regarding claim 54, Rosner teach RT-qPCR [0360] and microarray [0046], for example.
Regarding claim 55, expression levels of peptides can be determined with ELISA, Western blotting, and mass spec, for example. (claims 21).
Regarding claim 56, Rosner teach a method of diagnosing breast cancer at any stage. [0211, 0229]. Additionally, claim 56 recites all stages of breast cancer and therefore, as Rosner is diagnosing and prognosing cancer, the limitations of the claim are satisfied.
Regarding claim 59, Rosner teach wherein the sample is saliva, blood, tissue or urine. [0193].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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/MINDY G BROWN/Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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