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 is a Final Office Action.
Election/Restrictions
Applicant's election without traverse of Group I in the reply filed on October 25, 2024 is acknowledged. Group I, drawn to a deuterated pyrrolo[2,3-d]pyrimidine, and compositions thereof, embraced by claims 10-21 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elects the following species:
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as the phosphate salt.
Claims 10-21 are pending and under consideration.
Claim Rejections - 35 USC § 112
The rejection of claim 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the preamble stating “The method of claim 18” but claim 18 being drawn to a pharmaceutical composition, is withdrawn based on the amendments.
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 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 10-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rodgers et al. (US 7598257) in view of Rodgers’ et al. (US 20080312259), Concert Backgrounder (2007, provided on the IDS), Schilling et al. (Drug Metabolism and Disposition, 2010, 38(11), pp. 2023-2031), and JAKAFI® label (2011, provided on the IDS).
The instant application claims compound 111 or a pharmaceutically acceptable salt thereof, e.g., a phosphate salt, wherein each position in the compound designated specifically as deuterium has at least 90% incorporation of deuterium.
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.
The ‘257 patent teaches the following compound:
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, see claim 2 of the ‘257 patent. The primary reference teaches the phosphate salt in the Remington’s Pharmaceutical Sciences reference, which is incorporated by reference in its entirety, see column 32, lines 64-67.
The phosphate salt of the compound shown above, (also known as ruxolotinib or Jakafi®), is also taught in the ‘259 application, see page 6, Example 2.
Ruxolinitinb is an FDA approved drug with common adverse reactions associated with the use of it that include thrombocytopenia, anemia, bruising, dizziness and headache, as noted by Jakafi® label (ruxolitnib).
Neither the ‘257 patent or the ‘259 publication teach the claimed compound with a deuterium incorporation of at least 90%, which is more than the natural abundance of deuterium. Thus, the only difference between the claimed and cited compound is H versus Applicant's deuterium of at least 90% on the cyclopentyl ring.
As first branch, one is motivated to prepare deuterated versions of drugs to obtain a version with better pharmaceutical properties. Secondly, and as an alternative branch, one is motivated to prepare deuterated versions of drugs, which can be used to obtain valuable information about how the un-deuterated drug or closely related drugs act in the body.
The Concert Backgrounder is a marketing publication issued by Applicant. It teaches that deuteration of compounds provides the potential for improved safety, better tolerability, and enhanced efficacy. "[S]ince deuterium is heavier than hydrogen, it forms significantly stronger bonds with carbon resulting in differentiated ADME (Adsorption, Distribution, Metabolism, and Excretion)… [Hence,] [d]euterium substitution has the potential to create NCEs [new chemical entities] with improved safety, tolerability and efficacy."). The Concert Backgrounder observes that "the magnitude and nature of the deuterium benefit cannot be predicted a priori," so it is necessary to first "test multiple compounds in a range of assays to identify those that are differentiated." It further emphasizes, however, that "[d]euteration provides novel agents with the potential for ... [i]mproved safety[,] ... [b]etter tolerability[,] .. . [and] [e]nhanced efficacy, " adding that Concert “is deploying its product technology platform to rapidly assemble a pipeline of valuable new deuterated drugs."
Thus, one is motivated to prepare deuterated drugs to gain these explicitly set forth advantages. This provides a strong motivation, to obtain these advantages.
Hence, it is clear that under either of these two branches, “a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and that there would have been a reasonable expectation of success." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 80 USPQ2d 1641, 1645.
Moreover, given that there is always a need to enhance the pharmacological effects of a compound (e.g. increased in vivo half-life) without significantly altering its basic chemical structure (first branch), or that there is always a need to reduce the time, cost, risk, and statistical imprecision of pharmacokinetic studies (e.g. measure bioavailability or identify metabolites) (second branch), and that there is only a limited number of ways that this can be done, it would be obvious to pursue a potential solution that has a reasonable expectation of success. See e.g. KSR International Co. v. Teleflex Inc., 1385, 1397; Pfizer, Inc. v. Apotex, Inc., 82 USPQ2d 1321; Alza Corp. v. Mylan Laboratories, Inc., 80 USPQ2d 1001; In re Kubin, 90 USPQ2d 1417; In re O’Farrell, 7 USPQ2d 1673, 1681; In re Eli Lilly & Co., 14 USPQ2d 1741; In re Ball Corp., 18 USPQ2d 1491.
In addition, it is clear under both branches that deuteration per se is a known improvement technique for getting a more useful version of the pharmaceutical, and that the improvement is of a predictable nature. Thus, it would have been obvious to one of ordinary skill in the pharmaceutical art to have applied this known improvement technique in the same way to the compound of the primary reference to obtain the results reasonably predictable from the secondary references. See e.g., KSR International Co. v. Teleflex Inc., 1385, 1396; Ruiz v. AB Chance Co., 69 USPQ2d 1686; In re Nilssen, 7 USPQ2d 1500.
As for the specific deuterated locations on the molecule, Shilling et al. disclose known in vivo metabolites of ruxolitinib, where 3 out of 5 oxidized metabolites occur on the cyclopentyl ring, Therefore, Shilling teaches a POSA that the oxidative metabolism “hotspot” on ruxolitinib is the cyclopentyl ring, and this is not prone to switching to a different portion of the molecule (metabolic switching).
Furthermore, a POSA would have deuterated at the site corresponding to Y2 and/or Y3 in Formula A or Formula I of the claims of the ’149 patent. In each instance, one would have deuterated at every Y2 and/or every Y3. This is because the number of deuterated compounds that a POSA would prepare to test is not large, especially in light of the information in Shilling describing the known metabolites of ruxolitinib. It would make no scientific sense to deuterate selectively only some or one of the sites of the cyclopentyl ring (i.e., some of Y2 or some of Y3) because Shilling explains that metabolism occurs at each of the four secondary methylenes of the cyclopentyl ring. Furthermore, deuterating at only some of Y2 or Y3 would result in the formation of unwanted diastereomers and would leave C-H bonds at that same position (i.e., Y2 or Y3) that would still be prone to metabolism. Thus, given the known metabolic “hotspots” on the cyclopentyl moiety of ruxolitinib, the most reasonable deuterated analogs would have been the derivatives shown below:
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and specific enantiomers of 3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-yl-1-yl]propanenitrile given the known metabolic “hotspots” on the cyclopentyl ring, as described by Shilling.
Schilling also teaches “7HPyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile (INCB018424[, ruxolitinib or Jakafi®]) is an orally active and potent inhibitor of JAKs with greater than 100-fold selectivity against a panel of 26 non-JAK kinases and is in development for the treatment of myeloproliferative neoplasms… INCB018424 has demonstrated efficacy in myelofibrosis, the most serious of the chronic myeloproliferative neoplasms for which there is no approved therapy,” see page 2023, first paragraph.
Therefore, it would be obvious to select ruxolitinib because of the common adverse reactions and the Concert backgrounder teaches deuterated derivatives provide the potential for improved safety, better tolerability, and enhanced efficacy. Moreover, Shillings teaches deuterating on the cyclopentyl ring of ruxolitinib at the specific locations as “hot spots” for ruxolitinib.
Thus, said claims are rendered obvious by the above references.
Applicant traverses by contending, “[A]lthough the compounds of Rodgers-I/Rodgers-2 are similar to Compound 111, Compound 111 and ruxolitinib are distinct compounds, and Applicants further notes that Compound 111 has properties which are unexpectedly different from ruxolitinib. For example, Applicant submits that the claimed compound exhibits (i) unexpected pharmacokinetics with an maximized therapeutic window; and (ii) a different metabolic profile than ruxolitinib. Further, as a result of these unexpected properties associated with the distinct claimed compound, the claimed compound is non-obvious, having superior efficacy and safety profile that could not have been predicted by one having ordinary skill in the art.”
This is not persuasive as explained below.
Applicant states, “Administration of the claimed compound, Compound 111, results in inhibition of two separate JAK signaling pathways, the JAK1/STAT pathway and the EPO/pSTAT5 pathway. While the inhibition of one pathway, the JAK1/STAT pathway, provides a benefit, the inhibition of the other pathway, EPO/pSTAT5 pathway provides a detriment. The duration of inhibition of the beneficial pathway versus the detrimental pathway is used to determine the "therapeutic window," which informs one having ordinary skill in the art about the risk-reward of administering different compounds to humans. The claimed compound, Compound 111, and ruxolitinib remain in the therapeutic window for a different period of time.
Applicant notes that arguments related to the "therapeutic window" of the claimed compound discussed below were presented previously during the Inter Partes Review of related U.S. Patent No. 9,249,149 (the "IPR Proceeding"). However, the present claims feature a narrower compound scope, for which the maximized therapeutic window has been clearly demonstrated. Thus, the presented arguments are more commensurate to the evidence presented in the IPR proceeding.
To reiterate the unexpected maximizing of the therapeutic window by Compound 111, attached to this paper as Exhibit A is the Declaration of Scott L. Harbeson from the IPR Proceeding (the "Declaration"). As explained in the Declaration, both the claimed compound (CTP-543, i.e., Compound 111) and ruxolitinib inhibit JAK1 and JAK2 (see Declaration, Table 1). The pharmacokinetic properties of both compounds were compared using a human crossover study. As shown in Table 3 of the Declaration, the claimed compound exhibits increased oral clearance (CL/F) and half-life (Tmz) in vivo compared to ruxolitinib. However, the Cmax, or maximum initial amount of drug present in the serum after administration, is not significantly different between the two compounds (see Declaration, Tables 3 and 4). Moreover, the pharmacokinetic profiles of the two compounds were used to compare their respective therapeutic windows, which demonstrates an unexpected, maximized safety profile of the claimed compound that is not observed with ruxolitinib.”
The graph below shows the therapeutic window comparison.
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However, "[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Moreover, MPEP 2145 states, “Evidence pertaining to secondary considerations must be taken into account whenever it has been properly presented; however, it does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) (“the record establish[ed] such a strong case of obviousness” that allegedly unexpectedly superior results were ultimately insufficient to overcome obviousness conclusion); Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. 2007) (“given the strength of the prima facie obviousness showing, the evidence on secondary considerations was inadequate to overcome a final conclusion” of obviousness); and Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988).
The rejection expressly suggests an increased therapeutic window since deuterated versions of drugs are made to obtain a version with better pharmaceutical properties. Furthermore, the Concert backgrounder states, “[Hence,] [d]euterium substitution has the potential to create NCEs [new chemical entities] with improved safety, tolerability and efficacy."). Thus, the described therapeutic window is not unexpected.
Applicant further states, “As stated above, the Office alleged that the ruxolitinib of Rodgers-1 and Rodgers-2 is the closest prior art. Applicant reiterates ruxolitinib is a distinct compound and notes that Compound 111 is unexpectedly metabolized differently from ruxolitinib. Specifically, the enzyme predominantly responsible for the metabolism of Compound 111 is different from the enzyme predominantly responsible for the metabolism of ruxolitinib. While the predominant metabolizer of ruxolitinib (and many other drug compounds) is the cytochrome p450 enzyme CYP3A4, the enzyme predominantly responsible for the metabolism of the claimed compound is CYP2C9. This difference was completely unexpected and not suggested at all by the prior art.”
Applicant cites Shi et al., "Predicting Drug-Drug Interactions Involving Multiple Mechanisms Using Physiologically Based Pharmacokinetic Modeling: A Case Study with Ruxolitinib" Clinical Pharmacology & Therapeutics 00(00):1-9 (2014) (attached herewith as Exhibit B) to support the different route in which ruxolitinb is metabolized. Applicant provides Exhibit C to show the FDA-approved label for LEQSELVI™ tablets, which is also referred to as deuruxolitinib phosphate or CTP-543 and currently approved for the treatment of alopecia areata. Both documents provide support for less a reduction in drug-drug interactions with strong CYP3A4 inhibitors, e.g. ruxolitinib.
Again, and as noted in the rejection, the Concert Backgrounder expressly suggests that "[d]euteration provides novel agents with the potential for ... [i]mproved safety[,] ... [b]etter tolerability[,] .. . [and] [e]nhanced efficacy." Thus, a skilled person in the art is motivated to prepare deuterated drugs to gain these explicitly set forth advantages.
Applicant goes on to state, “In addition to the above-discussed differences, clinical studies have shown additional surprising differences between the claimed compound, e.g., deuruxolitinib, and the compounds of Rodgers-1 and Rodgers-2, e.g., ruxolitinib, in subjects with mild to moderate renal impairment. In particular, Applicant surprisingly demonstrated that administration of the claimed compound to subjects with mild to moderate renal impairment would not require a dose reduction or modification despite a reduction in renal function,” as provided in Exhibit C.
Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Assuming, arguendo, these are unexpected results, the claims are not limited to said population. Therefore, the claims are not commensurate in scope with the unexpected results.
Applicant further contends, “Nothing in Rodgers-1/2 teaches or even suggests that deuterium could be used to create a new compound with improved pharmacokinetics and in vivo efficacy let alone where to deuterate a compound to achieve these effects.
The Office's reference to the Concert Backgrounder and/or Shilling to cure this deficiency fails to establish a prima facie case of obviousness. While the Concert Backgrounder does vaunt the use of deuteration for marketing purposes, it recognizes that "the magnitude and nature of the deuterium benefit cannot be predicted a priori" requiring testing and experimentation (see Concert Backgrounder, page 2; emphasis added). In other words, absent actual empirical observation of the effect, the impact of deuteration, if any, cannot be deduced based on reasoning or general knowledge in the art…
With regard to Shilling, Applicant submits that this reference fails to even mention deuteration let alone provide instruction, motivation, or guidance for the one having ordinary skill in the art to deuterate one or more positions on the ruxolitinib compound. In fact, Shilling is focused on metabolite exposure in humans and states "it is critical to demonstrate that the exposure of major metabolites in humans does not exceed that observed in nonclinical species during toxicology assessments" (Shilling, page 2031). Furthermore, not only does Shilling fail to mention using deuteration, Shilling uses 14C as a radionuclide for labeling the ruxolitinib compound for profiling (see Shilling, page 2023).”
This is not persuasive. The rejection expressly suggests with the combination of references that deuterated versions of drugs are made to obtain a version with better pharmaceutical properties. In addition, it is clear that deuteration per se is a known improvement technique for getting a more useful version of the pharmaceutical, and that the improvement is of a predictable nature. Thus, it would have been obvious to one of ordinary skill in the pharmaceutical art to have applied this known improvement technique in the same way to the compound of the primary reference to obtain the results reasonably predictable from the secondary references. See e.g., KSR International Co. v. Teleflex Inc., 1385, 1396; Ruiz v. AB Chance Co., 69 USPQ2d 1686; In re Nilssen, 7 USPQ2d 1500.
Applicant further notes, “[T]hat the purported major metabolites of ruxolitinib, M18 and M16, show a hydroxylation or oxylation at only two positions of the cyclopentyl ring. Therefore, even if, for the sake of argument, the skilled artisan would use the teachings of the Concert Backgrounder and Shilling to deuterate ruxolitinib, there is still no rationale for modifying four positions on the cyclopentyl ring or expecting that eight deuterium would enhance metabolic stability in vitro compared to, for example, four deuterium in view of the references cited by the Office (see Declaration of Vinita Uttamsingh under 37 C.F.R. § 1.132, submitted on July 30, 2015, in parent application no. 14/707,912; the "Uttamsingh Declaration"). The Uttamsingh Declaration is attached herewith as Exhibit D, and the data is reproduced here for the Office's convenience (compare Compound 111 with Compound 103 and Compound 107):
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.”
As noted in the rejection, Shilling teaches a POSA that the oxidative metabolism “hotspot” on ruxolitinib is the cyclopentyl ring, and this is not prone to switching to a different portion of the molecule (metabolic switching). A skilled artisan would have deuterated at the site corresponding to Y2 and/or Y3 in Formula A. In each instance, one would have deuterated at every Y2 and/or every Y3. This is because the number of deuterated compounds that a POSA would prepare to test is not large, especially in light of the information in Shilling describing the known metabolites of ruxolitinib. It would make no scientific sense to deuterate selectively only some or one of the sites of the cyclopentyl ring (i.e., some of Y2 or some of Y3) because Shilling explains that metabolism occurs at each of the four secondary methylenes of the cyclopentyl ring. Furthermore, deuterating at only some of Y2 or Y3 would result in the formation of unwanted diastereomers and would leave C-H bonds at that same position (i.e., Y2 or Y3) that would still be prone to metabolism. Thus, given the known metabolic “hotspots” on the cyclopentyl moiety of ruxolitinib, the most reasonable deuterated analogs would have been the derivatives shown in the rejection. This is the rationale for modifying four positions on the cyclopentyl ring and expecting that eight deuterium would enhance metabolic stability.
Applicant further states, “Applicant submits that the presently claimed compound indeed satisfies the many decades long unmet need of an effective oral alopecia areata treatment that begins working rapidly (within 8 weeks) with long term efficacy (continued hair growth rather than plateauing)... As shown in the LEQSELVI™ label (Exhibit C), clinical studies showed that, compared to placebo, there is a significant increase in patients with severe alopecia who were administered the claimed compound that exhibited a severity of alopecia tool (SALT score) of less than 20 after only 8 weeks (see Exhibit C, Figure 1)…The Office's attention is directed to the Declaration of Julian Mackay-Wiggan, which was previously submitted in the IPR Proceeding, and which is attached herewith as Exhibit E. Even as early as 2018 when the declaration was submitted, Dr. Mackay-Wiggan explains that the data on the claimed compound looked "very promising" for the treatment of alopecia areata (see, Exhibit E, paragraph 38)... Despite this Declaration explaining that finding a safe and effective treatment of alopecia areata was a long felt but unmet need, the Board stated that the pronouncement that Applicant has satisfied the long felt but unmet need was premature since the FDA had yet to approve the claimed compound for the treatment of alopecia areata (see IPR Decision, page 36)… However, as discussed above, the FDA approved the use of LEQSELVI™ tablets for the treatment of alopecia areata in July of 2024 (see Exhibit F), thereby negating the Boards rationale.”
This is not persuasive. MPEP 2145 states, “Evidence pertaining to secondary considerations must be taken into account whenever it has been properly presented; however, it does not necessarily control the obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) (“the record establish[ed] such a strong case of obviousness” that allegedly unexpectedly superior results were ultimately insufficient to overcome obviousness conclusion); Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. 2007) (“given the strength of the prima facie obviousness showing, the evidence on secondary considerations was inadequate to overcome a final conclusion” of obviousness); and Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988).
However, the drug Olumiant® (baricitinib) received its first U.S. FDA approval in May of 2018 as a JAK inhibitor (same as the present mode of action) for rheumatoid arthritis and in June of 2022 for alopecia areata, which was two years prior to the approval of Applicant’s LEQSELVI ®, which was approved in July of 2024. Another drug, Litfulo ® (ritlecitinib), also a JAK inhibitor, was approved by the FDA in June of 2023, one year prior to Applicant’s approval. Both baricitinib and ritlecitinib are approved for oral administration to treat alopecia areata.
Thus, the rejection is maintained.
Applicant may consider requesting a Pre-Appeal Conference to move forth with prosecution.
Double Patenting
No non-statutory obviousness-type double patenting (NSDP) rejection over co-pending application 18905925 is being made because the ‘925 application is a divisional application of the present application based on the species election of myelofibrosis.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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