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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/14/2025 has been entered.
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 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Claims 8, 22, 29 are withdrawn as being drawn to a nonelected species.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Withdrawn Rejection
The 35 USC 112a New Matter rejection made in the previous office action is withdrawn based upon amendments to the claims.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 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 17,21,23-28,30 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 17,21,23-28,30 are drawn to a diagnosing MPN based upon the presence of type 1 or type 2 mutations are detected. The claims are drawn to determination of type 1 and/or type 2 mutation is present wherein the calculated determinator value or 1 is higher than the cutoff value 1 and when the calculated determination of value 2 is lower than the predetermined cutoff value 2. The claims state that the predetermined cutoff value 1 is from an average value and standard deviation of determination value 1 and the predetermined cutoff value 2 is from an average value and standard deviation of determination value 2.
The specification teaches that average values can be used as a threshold value using a particular formula (para 68). However, the specification does not provide that threshold value is the same as predetermined cutoff. Further, paragraph 68 is drawn to a plurality of values whereas it is not clear if the claims predetermined cutoff are determined with the sample or other specimens. The specification teaches in table 5 specific average values however it is not clear if the claims are intending to be limited to this value. However, the specification has not described the breadth of the claim language. Paragraph 15 probes that a formula and determination of gene mutation is present when value 1 is higher and value 2 is lower than a predetermined cutoff value. However, although the specification states this language it is not clear if this cutoff value is identical to a threshold value. Furthermore it is not clear how the average and standard deviation is measured when only one sample is detected.
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 “used for diagnosis” in the last line of claim 17. The phrase is indefinite as it is not clear how to perform the preamble of diagnosis with the steps of data analysis. By the term “used for” the claims can be interpreted as having non specified other steps to diagnosis. As such it is not clear the metes and bunds of diagnosis.
Claims 17,21,23-28,30 are indefinite over the phrase “calculating a predetermined cutoff value 1 from an average value and standard deviation of determination value 1; calculating a predetermined cutoff value 2 from an average value and standard deviations of determination of value 2” recited in claim 17. These steps are unclear as it is not clear what average or standard deviations are from. Determination value 1 is only required in one subject and as such it is not clear how an average or deviation is determined.
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