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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 5, 2025 has been entered.
Status of Claims/Rejections
Claims 1-4, 7, and 10-51 are currently pending in the instant application.
The restriction requirement for the species in group I and that among groups I, III, IV, and VI as set forth in the Office action mailed on March 1, 2022 have been reconsidered. Upon reconsideration, previously withdrawn claims, claims 12, 31-41, and 49-50, are hereby rejoined as they require and/or overlap in scope with the previously examined claims.
Accordingly, the restriction requirement is hereby withdrawn among groups I, III, IV, and VI.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 16-30 and 42-48 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Accordingly, claims 1-4, 7, 10-15, 31-41, and 49-51 are under examination on the merits in the instant application.
Any rejections not repeated in this Office action are withdrawn, and the following rejections are the only rejections applied in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 5, 2025 has been considered by the examiner. Note that Foreign Patent Document Citation No. 4 is not considered as a legible copy of the reference is not submitted.
Claim Objections
Claim 40 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 7, 10-12, 15, 31-34, 41, and 49-51 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.
Claim 7 recites that the imetelstat at about 8.9 mg/kg is intravenously administered for “1” dosage cycle, wherein “each cycle” is “once every three weeks.” This limitation is internally conflicting because the single dose pertaining to “1” dosage cycle cannot occur “once every three weeks” as required by the claim.
Claim 10 recites “further comprising determining average relative telomere length” “in a biological sample from the patient.” It is unclear whether this additional, “further” step is performed after or prior to the “administering” step. It is also unclear whether the step of claim 10 is performed after or prior to the “determinizing” step of claim 1. That is, claim 10 fails to particularly point out and distinctly claim the sequential order of the three different method steps recited in the claim, thereby rendering the method of claim 10 ambiguous and unclear.
Claim 11 recites “the determining comprises selecting a patient having an average relative telomere length”. It is unclear whether the “selecting a patient” step recited in claim 11 should occur prior to the two steps recited in claim 1. It is also unclear whether the patient being treated in claim 11 has a triple negative status and the shorter relative telomere length, thereby further limiting the patient population being treated by claim 11.
Claims 10 and 11 each recite “target cells”. It is unclear which cells should be “target cells” as no particular cell is being targeted in claim 1 as currently written.
Claim 11 recites “characterized cell lines.” The claim fails to particularly point out and distinctly claim the type of characteristic(s) the cell lines should have or how the cell lines should be “characterized”. That is, it is unclear what is meant by “characterized”.
Claim 12 recites “further comprising screening a patient to determine if the patient has a high-molecular risk (HMR)”. It is unclear how this “screening” method step in claim 12 is related to treating a patient having a triple negative status. That is, claim 12 fails to particularly point out and distinctly claim how the HMR status is related to the triple negative status and how the HMR status screening leads to the treatment of the specific MF patient population having a triple negative status. Further, as currently written, it is unclear whether the patient being treated in claim 12 is required to have both the triple negative status and the HMR status.
Claim 15 recites “altering the dosage of the imetelstat or imetelstat sodium” or altering “the course of therapy administered to the subject.” Claim 1 as currently amended requires that the MF patient having a triple negative status should be treated by fixed a course of therapy comprising administering a specific dosage for imetelstat (about 8.9 mg/kg) and for imetelstat sodium (about 9.4 mg/kg), whereas claim 15 also recites, by virtue of claim dependency, that the specific dosage as well as the course of therapy should be altered. Hence, claim 15 recites conflicting limitations (fixed vs. altered) pertaining to the administering step, thereby rendering the claim indefinite. In addition, claim 15 fails to particularly point out and distinctly claim how the “dosage” and “course of therapy” should be altered. Accordingly, the metes and bound of claim 15 pertaining to the altered dosage and altered course of therapy cannot be clearly ascertained.
Claims 31-34 recite “one or more known standards.” It is noted that the “known standards” may differ for different artisans, wherein use of different known standards may render different results. As such, the “known standards” are not consistent/fixed but rather widely variable. Hence, the clear metes and bounds of the “known standards” cannot be ascertained.
Claim 36 recites the limitation "the myelofibrosis" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites “further comprising screening a patient to determine if the patient has a high-molecular risk (HMR)”. It is unclear how this “screening” method step in claim 39 is related to treating a patient having a triple negative status. That is, claim 39 fails to particularly point out and distinctly claim how the HMR status is related to the triple negative status and how the HMR status screening leads to the treatment of the specific MF patient population having a triple negative status. Further, as currently written, it is unclear whether the patient being treated in claim 39 is required to have both the triple negative status and the HMR status.
Claim 41 recites “further comprising obtaining a sample that comprises DNA from the patient.” The claim fails to particularly point out and distinctly claim when this “further” step of “obtaining a sample” should occur in relation to the steps recited in claim 35.
Claim 49 recites the limitation "the patient" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 50 recites the limitation "assessed" in line 2. There is insufficient antecedent basis for this limitation in the claim. Note that claim 49 does not recite a method step of “assessing”.
Claim 51 recites that the imetelstat sodium at about 9.4 mg/kg is intravenously administered for “1” dosage cycle, wherein “each cycle” is “once every three weeks.” This limitation is internally conflicting because the single dose pertaining to “1” dosage cycle cannot occur “once every three weeks” as required by the claim.
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 31-41 and 49-50 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.
The instant claims are broadly drawn to methods that encompass any “telomerase inhibitor”. The term “telomerase inhibitor” reads on structurally diverse compounds in various chemical classes as such inhibitor is known to encompass and are not limited to the following: “6-thio-2’-deoxyguanosine (6-thio-dG)”, “zidovudine (also known as azidothymidine)”, “stavudine”, “tenofovir”, “didanosine”, “abacavir”, “rhodocyanine (also known as FJ 5002)”, “EGCG or pro-EGCG”, “MST-312 (an EGCG derivative)”, “curcumin”, “genistein”, “TMPI”, “telomestatin”, “RHPS4”, “BRACO-19”, “TMPyP4”, “tertomotide”, “imetelstat sodium” (or “imetelstat (GRN163L))”, “ASTVAC-1”, “GX-301”, and “UCPVax”. See paragraphs 0046 and 0093 of Villanueva (US 2019/0282600 A1).
The instant specification is found to describe methods that administers “imetelstat sodium” (or “imetelstat (GRN163L))” as the “telomere inhibitor” at a specific dosage. Since imetelstat or imetelstat sodium at a specific dosage is not a representative number of species reflecting a myriad of different telomerase inhibitor species known in the relevant art, the instant specification’s disclosure is far from adequately supporting the instantly claimed methods reciting a broad genus of “telomerase inhibitor” in such a way to reasonably convey that the instant co-inventors had possession of the entire genus as of the filing date sought in the instant application.
Claims 35-41 recite “selecting a patient most likely to benefit from treatment with a telomerase inhibitor”, wherein the selected patient has the triple negative status.
The instant specification does not provide any adequate written description support that the triple negative patient is “most” likely to benefit from a telomerase inhibitor as the specification is deficient in the comprehensive data comparing treatment effects across all possible patients receiving the entire genus of telomerase inhibitors or the disclosed species of imetelstat or sodium salt thereof.
Solely in the interest of compact prosecution, the word “most” in line 1 and line 6 of claim 35 will not be taken into consideration.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Caocci et al. (Blood, 2016, 128(22):3116, Abstract No. 634) in view of Tefferi (American Journal of Hematology, 2016, 91:1261-1271, of record) and Bassett et al. (US 2014/0155465 A1, of record).
Caocci discloses a method of treating a myelofibrosis patient who is determined to have a reduced relative telomere length (RTL) when assessed by q-PCR, wherein the method comprises administering ruxolitinib, which resulted in a significant increase in median RTL, “showing overlapping values with the healthy controls”, thereby “restoring telomere lengths to normal values.” Hence, Caocci suggests a potential “about the rationale of treatment with telomerase inhibitors in MF patients.” See the entire abstract including Figure.
Caocci does not expressly teach 50 percentile or less for the telomere length. Caocci does not teach that the MF patient should receive or not receive ruxolitinib (JAK inhibitor) prior to the “treatment with telomerase inhibitors”.
Tefferi teaches that high-risk primary myelofibrosis (PMF) patients treated with JAK inhibitors discontinue therapy because of “adverse events” or “adverse reactions” to JAK inhibitors such that the “long-term outcome of ruxolitinib therapy in MF was recently reported and disclosed a very high treatment discontinuation rate (92% after a median time of 9.2 months)”. See pages 1268-1269.
Tefferi teaches that PMF “is a myeloproliferative neoplasm”. See abstract.
Bassett teaches a method of treating hematological cancer including “myeloproliferative diseases” or “chronic myeloproliferative disorders” by administering imetelstat to a subject who is determined to have “50th percentile or less of a relative telomerase length range” in a biological sample, wherein such subject is deemed to “benefit from treatment with telomerase inhibitor therapy”. See paragraphs 0009-0010 and 0086; claims 1-7, 9, and 20.
It would have been obvious to one of ordinary skill in the art before the effective filing date to practice and/or modify the “treatment with telomerase inhibitors” suggested by Caocci, who selected an MF patient having a reduced RTL and administered a therapeutic JAK inhibitor, ruxolitinib, which resulted in an increased RTL in the patient. One of ordinary skill in the art would have been motivated to provide the “treatment with telomerase inhibitors” in lieu of ruxolitinib to an MF patient having a reduced RTL as such treatment was expressly suggested as a potential treatment for increasing telomere length as evidenced by the disclosure of Caocci. One of ordinary skill in the art would have been also motivated, with a reasonable expectation of success, to provide “treatment with telomerase inhibitors” to a PMF patient who discontinued JAK inhibitor (ruxolitinib) treatment due to “adverse” effects because ruxolitinib treatment was known to be associated with “adverse” events/reactions leading to “a very high treatment discontinuation rate” as taught by Tefferi because one of ordinary skill in the art was taught that both ruxolitinib (a JAK inhibitor) and imetelstat (a telomerase inhibitor) were each suggested to be useful and beneficial in a patient having a reduced RTL as evidenced by Caocci and Bassett, wherein it was known in the art that patients with MF including PMF were known to have a reduced RTL, wherein imetelstat was taught to be particularly useful for a patient who is determined to have “50th percentile or less of a relative telomerase length range” in a biological sample as taught by Bassett.
Accordingly, claims 31-34 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 31-41 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Tefferi et al. (Leukemia, 2014, 28:1472-1477, of record; Tefferi (2014) hereinafter) in view of Tefferi (American Journal of Hematology, 2016, 91:1261-1271, of record; Tefferi (2016) hereinafter), Bellanne-Chantelot et al. (WO 2016/207405 A1, of record), Mosoyan et al. (Leukemia, 2017, 31:2458-2467, of record), Bassett et al. (US 2014/0155465 A1, of record), and Trehu et al. (US 2018/0318303 A1).
Tefferi (2014) teaches a method of screening a “total of 254 patients (median age 64 years; 65% males) with WHO-defined PMF” and identifying “triple-negative myelofibrosis” patients, wherein the triple-negative genotype is considered “as high-risk molecular signatures in PMF.” See title; abstract; page 1473; and Table 1.
Tefferi (2014) reports, “Prognosis was particularly worse for triple-negative patients with median survival of only 2.5 years” thus “‘triple-negative’ PMF should now be considered as a molecularly high-risk disease”. See pages 1474-1475.
Tefferi (2014) does not teach administering imetelstat for treating the triple-negative PMF patient who is considered to have a “high-risk disease”.
Tefferi (2016) teaches that “intermediate-2 or high-risk” primary myelofibrosis (PMF) patients “should be considered for ASCT or investigational drug therapy, sooner than later.” See page 1268.
Tefferi (2016) teaches that high-risk PMF patients “should first be offered participation in investigational drug therapy before treatment with conventional drugs including JAK inhibitors.” See page 1268.
Tefferi (2016) teaches that high-risk PMF patients treated with JAK inhibitors discontinue therapy because of “adverse events” or “adverse reactions” to JAK inhibitors such that the “long-term outcome of ruxolitinib therapy in MF was recently reported and disclosed a very high treatment discontinuation rate (92% after a median time of 9.2 months)”. See pages 1268-1269.
Tefferi (2016) discloses that “many other drugs are being tested for their therapeutic value in MF and the most intriguing results were recently reported with the use of imetelstat, which is a 13-mer lipid-conjugated oligonucleotide that targets the RNA template of human telomerase reverse transcriptase.” See page 1269.
Bellanne-Chantelot discloses that triple negative MPN (myeloproliferative neoplasm) patients are “defined by the absence of the V617F mutation in JAK2, W515R mutation in MPL and the 52-bp deletion (pL367Tfx*46) or the 5-bp insertion (K385Nfs*47) in CALR.” See Table 1, which discloses four triple negative patients initially diagnosed with essential thrombocythemia (ET) and are still alive, wherein what ET in the triple negative patients evolved to (e.g., MF) has not been determined.
See also Figure 8 reproduced below showing “Triple negative” occurs in 25% of patients; MPL mutations occur in 8%; CALR mutations occur in 17%, and JAK2 mutations occur in JAK2.
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Bellanne-Chantelot teaches the following at page 48: “Importantly, the spectrum of acquired driver mutations leading to ET included JAK2V617F, MPL and CALR mutations as well as triple negative cases, similarly to sporadic ET cases.”
Bellanne-Chantelot discloses that “an ET-suffering patient will develop a myelofibrosis” and that a patient having ET has “rapid progression to MF” as “the worsening of the disease” of ET and that “ET with a high frequency of evolution to MF” is known. See pages 1 and 3.
Mosoyan reports that “imetelstat treatment led to a significant decrease in hTERT”, whose “mRNA” expression level is reduced after the treatment. See page 2461.
Bassett teaches a method of treating hematological cancer by administering imetelstat to a subject who is determined to have “50th percentile or less of a relative telomerase length range” in a biological sample, wherein such subject is deemed to “benefit from treatment with telomerase inhibitor therapy”. See paragraphs 0009-0010; claims 1-7, 9, and 20.
Trehu teaches a method of testing/evaluating a biological sample containing “genomic DNA” from patients with primary myelofibrosis, post-PV MF, or post-ET MF for the “mutational status in one or more genes such as JAK2, MPL, CALR, ASXL1, EZH2, SRSF2, IDH1, and IDH2.” See paragraphs 0020, 0110, 0117, and 0333.
It would have been obvious to one of ordinary skill in the art before the effective filing date to select a triple-negative MF patient for imetelstat treatment. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to provide an increased likelihood of clinical benefit to the patient having the MF that is deemed a “molecularly high-risk disease”, because identifying/determining whether an MF patient is triple-negative was already practiced in the relevant art and was deemed useful and/or necessary in order to identify a “high-risk” MF patient population and provide an “investigational drug therapy” “sooner than later” in clinical trials as suggested and taught by the combined teachings of Tefferi (2014) and Tefferi (2016), wherein Tefferi (2016) expressly advised relevant artisans (e.g., clinicians, medical professionals) that the “high-risk” MF patients known to include triple-negative MF patients “should first be offered participation in investigational drug therapy before treatment with conventional drugs including JAK inhibitors”, wherein imetelstat was an art-recognized investigational MF therapy drug. As such, one of ordinary skill in the art would have reasonably selected a triple-negative, “high-risk” MF patient as a patient to be one of the MF patient populations to be likely to have an increased likelihood for clinical benefit thus would have administered imetelstat to the selected triple-negative, “high-risk” MF patient for providing clinical benefit. One of ordinary skill in the art would have had a reasonable expectation of identifying and selecting a triple-negative primary myelofibrosis (PMF) patient or a triple-negative post-essential thrombocythemia (post-ET MF) patient for imetelstat treatment because it was an art-recognized, objective fact that PMF patients do have the triple-negative genotype as evidenced by Tefferi (2014), and because it was also an art-recognized, objective fact that ET patients do have the triple-negative genotype and progress to MF such that “an ET-suffering patient will develop a myelofibrosis” as taught by Bellanne-Chantelot. Further, since PMF patients were known to be treated with JAK inhibitors but discontinue due to adverse reactions as disclosed by Tefferi (2016), there would have been a reasonable expectation that the triple-negative PMF patient being treated with imetelstat was previously treated with JAK inhibitors but discontinued due to adverse reactions. One of ordinary skill in the art would have also been motivated to test a genomic DNA of the MF patient for the “mutational status” in one or more of “ASXL1, EZH2, SRSF2, IDH1, and IDH2” because such test was known to be performed in MP patients as evidenced by Trehu.
It would also have been obvious to one of ordinary skill in the art to select a triple-negative MF patient who is determined to have “50th percentile or less of a relative telomerase length range” in a biological sample in order to provide a higher likelihood of clinical benefit to the patient because such patient having “50th percentile or less of a relative telomerase length range” was known to “benefit from treatment with telomerase inhibitor therapy” as taught by Bassett. It would also have been obvious to one of ordinary skill in the art to assess hTERT expression levels in the imetelstat treated triple-negative MF patient and to verify “a significant decrease in hTERT” in the treated patient in order to monitor the efficacy of the telomerase inhibitor, imetelstat, in the treated patient, because imetelstat was known to provide “a significant decrease in hTERT”, whose mRNA expression is reduced after the treatment as reported by Mosoyan. That is, it was reasonably established in the relevant art that a reduced level of hTERT mRNA expression is indicative of the efficacy of imetelstat’s intended function thus one of ordinary skill in the art would have utilized hTERT mRNA as a prognosis biomarker when treating MF patients with imetelstat, wherein one of ordinary skill in the art would have deemed a reduction level by more than half (50%) as the significant reduction in hTERT mRNA that is clinically or therapeutically relevant through routine screening assays.
In view of the foregoing, claims 31-41 and 49-50 taken as a whole would have been prima facie obvious before the effective filing date.
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 35-41 and 49-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 35-41 recite a method that requires mental steps/processes including “selecting a patient most likely to benefit from treatment with a telomerase inhibitor”; “testing a patient for triple negative status”; “selecting the patient”; and “screening a patient”. The claims also recite a law of nature/natural principle that the gene mutation status (absence or presence) correlates with a beneficial biological response to a treatment. That is, the claims recite a natural correlation between the naturally occurring genetic mutations (absence) in a living subject and the subject’s biological response (favorable) to a treatment.
Claims 49-50 recite a method that requires mental steps/processes including “monitoring therapeutic efficacy”, “measuring”, and “comparing”, wherein the method also recite a natural correlation that the hTERT expression level in a biological sample correlates with a favorable treatment response.
Note that a mental process includes observations, evaluations, judgments, and opinions, and the recitation of “comparing BRCA sequences and determining the existence of alterations” in claims was determined to recite a mental process that can practically be performed in the human mind thus was deemed to recite an abstract idea judicial exception. See University of Utah Research Foundation v. Ambry Genetics Corp., 774 F. 3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014). See also “October 2019 Patent Eligibility Guidance Update” issued on October 17, 2019.
The abstract idea judicial exception, the mental processes of “selecting”, “testing”, “screening”, “monitoring”, “measuring”, and “comparing” that can be performed in the human mind, is not integrated into a practical application because the recited steps amount to simply implementing the abstract idea (mental processes) in order to link the gene expression to the law of nature such that the gene expression status/level is naturally correlated with treatment response. That is, the instantly recited abstract idea that is performed in the human mind with or without a physical aid, thus a mental process, is used for another judicial exception, which is the natural law/principle.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the “inventive concept” in the instant claims is furnished by the law of nature/abstract idea itself. Note that an inventive concept “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.” Genetic Technologies Ltd. v. Merial LLC, 818 F. 3d 1369, 1377, 118 USPQ 2d 1541,1547 (Fed. Cir. 2016).
In addition, the additional method steps of “administering the telomerase inhibitor to the patient” and “obtaining a sample that comprises DNA from the patient” as recited in claims 40-41, respectively, are “recited at such a high level of generality”. Hence, the additional physical steps fail to integrate the natural correlation/abstract idea judicial exceptions into a practical application.
In view of the foregoing, claims 35-41 and 49-50 are patent ineligible under §101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,200,327 B2 in view of Tefferi (American Journal of Hematology, 2016, 91:1261-1271, of record) and Caocci et al. (Blood, 2016, 128(22):3116, Abstract No. 634).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the method of ‘327 patent claims drawn to a method of treating an individual with “a cancer” who is “determined to be in the 50th percentile or less of a relative telomere length range”, wherein the individual “will benefit from treatment with a telomerase inhibitor” thus is treated with a telomerase inhibitor. It is noted that the “cancer” in the individual being treated in the ‘327 patent claims is defined to read on “myeloproliferative diseases” or “chronic myeloproliferative disorders” in the ‘327 patent specification. It would have been obvious to one of ordinary skill in the art to readily envision that the cancer being treated in the ‘327 patent claims reads on primary myelofibrosis (PMF) claimed in the instant case as evidenced by the fact that the cancer is defined to read on “myeloproliferative diseases” or “chronic myeloproliferative disorders” and further in view of the art-recognized knowledge that PMF is a myeloproliferative cancer (neoplasm) as evidenced by Tefferi. It would also have been obvious to treat a PMF patient having been previously treated with a JAK inhibitor or a PMF patient who has not been treated with a JAK inhibitor in view of the teachings of Tefferi and Caocci as explained in the §103 rejection above, which is fully incorporated by reference herein.
Claims 31-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 9,375,485 B2 in view of Tefferi et al. (Leukemia, 2014, 28:1472-1477, of record; Tefferi (2014) hereinafter) in view of Tefferi (American Journal of Hematology, 2016, 91:1261-1271, of record; Tefferi (2016) hereinafter), Bellanne-Chantelot et al. (WO 2016/207405 A1, of record), Mosoyan et al. (Leukemia, 2017, 31:2458-2467, of record), Bassett et al. (US 2014/0155465 A1, of record), Trehu et al. (US 2018/0318303 A1), and Caocci et al. (Blood, 2016, 128(22):3116, Abstract No. 634).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the method of treating an MF patient of the ‘485 patent claims comprising “administering a clinically effective amount of a telomerase inhibitor” to the “individual in need thereof” who is “diagnosed with” MF. It would have been obvious to one of ordinary skill in the art to envisage that the “individual in need” of the treatment who is diagnosed with MF as claimed in the ‘485 patent claims would encompass and read on a myelofibrosis patient who has no genetic mutation in JAK2, CALR, and MPL genes, because “high-risk” MF patients were known to have received clinical benefit from imetelstat treatment as disclosed in Stuart and imetelstat treatment was recommended for treating high-risk MF as taught by Tefferi (2016), and because triple-negative genotype recited in the instant claims was known as a “high-risk” MF as evidenced by Tefferi (2014) and Rumi. Further, the limitations recited in the instant claims would have been obvious in view of the combined teachings of Tefferi (2014), Tefferi (2016), Bellanne-Chantelot, Mosoyan, Bassett, Trehu, and Caocci as explained in the §103 rejections above, which are fully incorporated herein by reference thus will not be repeated.
Claims 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,391,946 B2 in view of Caocci et al. (Blood, 2016, 128(22):3116, Abstract No. 634), Tefferi (American Journal of Hematology, 2016, 91:1261-1271, of record), and Bassett et al. (US 2014/0155465 A1, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the MF treatment of the ‘946 patent claims comprising administering ruxolitinib and imetelstat to “a subject having a myeloproliferative neoplasm” that is “myelofibrosis (MF)”. It would have been obvious to one of ordinary skill in the art to readily envisage that the “subject” being treated in the ‘946 patent claims would have a PMF and a shorter RTL (e.g., “50th percentile or less”) as evidenced by the teachings of Caocci, Tefferi, and Bassett, which are described in the §103 rejection above thus will not be repeated herein.
Allowable Subject Matter
Claims 1-4 and 13-14 are in condition for allowance.
Conclusion
Claims 7, 10-12, 31-41, and 49-51 are rejected.
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/DANA H SHIN/Primary Examiner, Art Unit 1635