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 .
This action is in response to papers filed 7/09/2026.
The species elections has been maintained. The species of JAK2 V617F, CALR type I, and MPL W515K in the reply filed on 6/22/2021 and 10/27/2021 is acknowledged.
Claims 8, 17, 21-30 are pending. Claims 1-7,9-16,18- 20,31 have been cancelled.
Claims 8, 22, 29 are withdrawn as being drawn to a nonelected species.
The following rejections for claims 17,21,23-28,30 are newly applied.
This action is Nonfinal.
Withdrawn Rejection
The 35 USC 112a and 35 USC 112b rejections made in the previous office action is withdrawn based upon amendments to the claims.
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 17,21,23-28,30 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.
Claims 17,21,23-28,30 are indefinite over “the cutoff values 1 and 2 are specified based on a plurality of determination values….”. This phrase is not clear as it is not clear if the claim is intending to refer to the predetermined cutoff values or some other undefined values. Further, the predetermined values is the average value and standard deviation whereas the cutoff values are specified based on a plurality of determination values 1 and 2, respectively, calculated”. Lastly it is not clear what specimens whose types have been confirmed is intending to limit and how type limits specimens.
Claims 25-28 are drawn to detecting MPL or JAK2, however, claim 17 is drawn to detection of CALR. As such it is not clear how these claims limit claim 17 as it appears to not require CALR and therefore the correlation to CALR for MPN.
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 17, 25-26,30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) calculation and determining steps which can be interpreted as abstract ideas. This judicial exception is not integrated into a practical application because using a kit comprising known gene fragments and measuring signals from a microarray using any hybridization method appear to be routine and conventional. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not integrate the judicial exception.
Question 1
The claimed invention is directed to a method that recites abstract ideas.
Question 2A – Prong 1
Claim 1 recites the patent ineligible concepts of abstract ideas or “calculating”. The steps of calculating and determining are abstract ideas. Calculating and determination are mental processes that can be performed in the human mind, such as by observation, evaluation, judgment or opinion. Methods that can be performed in the human mind, or by a human using a pen and paper are considered abstract ideas. Thus, the calculating and determination steps constitute abstract ideas. Therefore these steps are considered no more than an ‘instruction to apply the natural law’ and 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 2
The judicial exceptions are not integrated into practical application because the claims do not recite any additional elements that integrate the judicial exceptions into practical application of the exceptions.
Accordingly, the claims are directed towards judicial exceptions.
Question 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims do not add a specific limitation other than what is well-understood, routine and conventional in the field. The step of calculating is the judicial exception.
Even when viewed as a combination, the additional elements of the claims fail to transform the exceptions into patent-eligible applications of the exceptions. Thus, the claims as a whole do not amount to significantly more than the judicial exceptions themselves. The claims do require a kit that comprises mutations of a known gene and measuring signals, however these steps appear to routine and conventional as the specification discloses any array and assays can be used to detect the naturally occurring gene (see pages 2 and 13-16). The steps outlined above are merely well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, applied to the steps of calculating the expression values and determining the expression values. The claims do not recite additional elements that amount to significantly more than the judicial exceptions.
For those reasons, the claims are rejected under 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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached on 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
