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 .
Applicant’s preliminary amendment filed 10/18/2022, is acknowledged. Claims 1, 2, 5, 6, 12-16, 18, 21, 23, 26, 27, 29, 30, 32, 33, 35-37 and 39 are pending.
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, 6, 12-16, 18, 21, 23, 26, 27 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 1 recites the step of measuring the expression amount of DUSP5 in a blood cancer patient sample. This step is merely involve gathering data of a naturally occurring phenomenon. This judicial exception is not integrated into a practical application because the data gathered is used for correlation purposes in identifying or selecting a blood cancer patient, which in turn is merely a mental step or at best insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it does not involve administration of any drug nor does it elaborate on the type of sample.
Similarly, claim 2 is directed to a natural phenomenon without significantly more for the same reasons as claim 1. The only difference being that claim 2 is for the purpose of predicting the therapeutic effect of a drug to be used.
The method claims depending from claims 1 and 2 do not cure the failure of claims 1 and 2 to be directed to significantly more than a natural phenomenon.
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 1, 5, 6, 12-16, 18, 21, 23, 26, 27, 29, 37 and 39 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.
The term “low” in claims 1 and 2 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim. To be sure, the specification does provide examples of what types of samples would be considered low. However, while claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Even more problematic is claim 2 recitation of the terms “highly possibly” for which there is no description in the specification as to how this should be understood.
Claim 1 recites the limitation “the treatment using a drug comprising one or more DNA methyl transferase inhibitors,” “the expression amount of DUSP5 in a sample” and “reference expression amount of DUSP5.” There are insufficient antecedent bases for these limitations in the claim.
Claim 2 recites the limitation “the therapeutic effect of a drug comprising one or mo,” “the expression amount of DUSP5 in a sample” and “reference expression amount of DUSP5.” There are insufficient antecedent bases for these limitations in the claim.
Insofar as claims depend from claims 1 and 2, they are indefinite.
Regarding claims 37 and 39, they recite “a reagent for measuring the expression amount of DUSP5 mRNA or DUSP5 protein in a sample obtained from the patient.” This is a functional limitation. A claim limitation is functional when it recites a feature by what it does rather than by what it is. While functional limitations may be properly used in claims, the boundaries imposed by a functional limitation must be clearly defined to be definite under 35 U.S.C. 112(b). When claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Here, even a reagent that would not be considered directly, but rather indirectly, involved “for measuring the expression amount of DUSP5 mRNA or DUSP5 protein in a sample obtained from a patient” directly, would be encompassed by the functional limitation.
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.
Claim(s) 30, 32 and 33 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tutino et al. (US 2012/0196823).
Regarding claim 30, Tutino et al. provides “pharmaceutical compositions comprising cytidine analogs (e.g., 5-azacytidine or decitabine)” (current claim 33). Para. [0016]. The composition may be used to treat cancer. Id. Although Tutino et al. does not teach that the composition be used in the treatment of a blood cancer patient identified or selected based on the expression amount of DUSP5, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 32, Tutino et al. provides “pharmaceutical compositions comprising cytidine analogs (e.g., 5-azacytidine or decitabine).” Para. [0016]. The composition may be used to treat cancer. Id. Although Tutino et al. does not teach that the composition be used in a blood cancer patient to whom the therapeutic effect of a drug is predicted, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim(s) 37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kottwitz et al. (US 2017/0233820).
Regarding claims 37 and 39, Kottwitz et al. teaches a kit comprising a reagent capable of converting an unmethylated cytosine to uracil or to another base that is detectably dissimilar to cytosine in terms of hybridization properties and/or reagents such as buffers, nucleotides and/or polymerase for carrying out a PCR reaction.” Para. [0109]. Although Kottwitz et al. may not teach that these reagents are for measuring the expression amount of DUSP5 mRNA or DUSP5 protein in a sample, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614