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 1-20 are cancelled.
Claims 21-40 are newly added.
Claims 22 and 26 are withdrawn.
Claims 21, 23-25, and 27-40 are examined on the merits.
Election/Restrictions
Applicant's election with traverse of DECR1, JAM-2 and HG-EDF and their corresponding SEQ ID NOs: 43, 46, and 57 in the reply filed on 28 January 2026 is acknowledged. The traversal is on the ground(s) that the proteins should be examined with their nucleic acid sequences as this would not cause serious search burden. This is not found persuasive because the standard for restriction in an application filed as a national stage application under 35 USC 371 is unity of invention and not search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 22 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 28 January 2026.
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.
Claims 21, 23-25, and 27-40 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 treating rheumatoid arthritis (RA) with a disease-modifying anti-rheumatic drug (DMARD).
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 quantitative level of a biomarker in a biological sample from the subject and making a predicting a response to a treatment and administering a treatment based on that prediction. Such an invention has potential use in the art for treating RA, 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 treatment response and 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 quantitative level of a biomarker in the biological sample and make a predict a response to a treatment and administer a treatment based on that prediction. The aspects considered broad are: (i) the correlation between the biomarker and the treatment response; and (ii) the type of treatment. As will be shown below, these broad aspects are not enabled.
Predictability and State of the Art
The art is unpredictable. With respect to make a treatment response prediction based on a biomarker, the art does not show any correlation with the amount of a biomarker in a subject and how they will respond to a treatment. The claims recite specific biomarkers to be evaluated and administering a DMARD. The specification provides data regarding levels of markers after treatment with methotrexate, sulfasalazine, leflunomide, and hydroxycloroquine.
Bankaitis-Davis et al. teach the use of markers in biological samples to monitor disease progression. They teach that the subject is monitored over time to determine if their treatment is effective. (claim 1).
Cherlin et al. teach prediction of treatment response in RA patients using SNP data. However, their prediction models are based on patients already receiving treatment. (page 756).
There is nothing in the prior art to indicate that any biomarker from a subject can predict how that subject will respond to a DMARD treatment.
Hence, from the nature of the invention and the state of the art, the Artisan would not reasonably predict that determining the level of DECR1, JAM-1 or HG-EGF in a subject would be predictive of what treatment will be appropriate for the subject.
The Amount of Direction or Guidance/The Existence of Working Examples
The specification does not provide any guidance regarding predicting the appropriate treatment for an RA subject.
The specification provides data regarding patients that have already received treatment. The specification does not provide any data regarding any baseline for the biomarkers before they received treatment. At most the specification is providing biomarker results from a treatment. There is nothing in the specification to indicate that the end result of a biomarker level is indicative of their status before the treatment to indicate if the treatment would be appropriate.
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 establish a baseline of the biomarkers of the subject, administer a treatment, and then at some point after the patient has taken the drug, assess the biomarker again. This would need to be performed across a large population of patients for a wide variety of DMARDs.
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 21, 23-25, and 27-40 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 § 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 21, 23-25, and 27-40 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 biomarker level in sample to predict response to treatment and administering a treatment. 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 determining a biomarker level and predicting response to a treatment (e.g., claims 1, 11, and 21), they encompass the mental comparison of data and the correlation of data and information to reach a conclusion. Further, the treatment decision 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.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims include practical steps related to the administration of a DMARD to the subject, but the broadly recited step is considered routine and conventional and the claims are not significantly more than the judicial exceptions to which they are directed. Where the claims recite limitations of administering a DMARD, this is a known treatment for a subject with RA.
For these reasons, the claims are rejected under USC 35 section 101 as being directed to non-statutory subject matter.
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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