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 .
Response to Arguments
Applicants' arguments, filed February 27, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
New grounds of rejection are set forth in the Office Action due to the new claim language in independent claim 1 requiring the presence of PVP with levels of peroxide not exceeding a particular value and in claim 25 that depends from non-amended independent claim 24. While dependent claims previously required the presence of PVP or low peroxide grade PVP, no particular amounts of peroxide in the PVP was claimed. The failure of the previously applied prior art references to teach the new limitations are remedied by the newly applied Huang et al. reference as set forth herein.
Regarding the previously applied references that are still used in the new grounds of rejection, Applicants argue that motivation or rationale to combine the teachings with a reasonable expectation of success is required and objective indicia of non-obviousness are relevant to obviousness. The claimed oral dosage exhibits dissolution, hardness, friability and stability benefits that could not have been predicted based on the cited references. The disclosure provides an immediate release dosage form that dissolved in water in less than 30 minutes and rapidly releases the active ingredient into the bloodstream. In addition to the excellent dissolution profile, the claimed oral dosage form still exhibits excellent friability and hardness which could not have been predicted in view of the cited references. Superdisintegrants such as sodium starch glycolate enable rapid dissolution but this ingredient is not required by the claimed formulation. The skilled artisan would not expect an immediate release dissolution profile in the absence of a required superdisintegrant. The data in the specification shows less than 0.1% w/w of total degradation products after 4 weeks of storage at elevated temperature and humidity compared to the other dosage forms tested with CTP-543-ZH being undetectable after extended storage conditions, which was not seen in the other formulations tested and could not have been predicted in view of the cited combination of references.
These arguments are unpersuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., immediate release or particular time frame for dissolution in water and release into the bloodstream) are not recited in the rejected claim(s). Although the 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). Sodium starch glycolate is only excluded by claim 9 and even in the claims that lists specific percentages for each of the required ingredients, the dosage form comprises the recited ingredients whose absolute number totals to 99.75% and each amount is broadened by the use of the word “about”. Even those formulations could contain additional ingredients such as sodium starch glycolate. Sodium starch glycolate is not the only disintegrant/superdisintegrant known in the art. Jain et al. discloses sodium starch glycolate and substituted hydroxypropanyl cellulose amongst others at ¶ [0064] and no claims specifically exclude all disintegrants and/or superdisintegrants from the claimed compositions. In order for evidence of unexpected results to be persuasive, there must be a comparison of the claimed composition with the closest prior art and evidence of unexpected results that forms a nexus with the claims and is reasonably commensurate in scope with the claims. While the arguments cite to various data in the specification, there does not appear to be any comparison with any other product. When such comparisons are performed, Applicants must establish what the expected results would be and that the results obtained are in fact different from what is expected but that requires data for the comparison material which is not present in the record. Table 3 shows results for three different PVP but the level of peroxide in these materials is not disclosed so the amount of peroxide present in the tested formulations cannot be determined. Even for narrow claims such as claims 4 and 24, only total microcrystalline cellulose (MCC) of about 52% w/w is claimed while the formulation from the specification contained 33.25 wt% intragranular MCC and 19 wt% extragranular MCC (table 1 of the specification) and no explanation as to how only the total amount of MCC is relevant has been given. Therefore even if a comparison was set forth in the disclosure as filed, a nexus with the claimed compositions have not been established.
Regarding Jain et al., Applicants argue that Jain does not cure the deficiencies of JAKAFI® and Silverman and Jain et al. is drawn to an extended release formulation for daily administration with not less than 20% of the total amount of ruxolitinib being released with 2 hours and not more than 60% of the total amount being released within 3 hr in 0.1 N HCl. It is not surprising that Jain does not include a superdisintegrant such as sodium starch glycolate given the sustained and not immediate release nature of the formulations. Applicants have demonstrated the criticality of the claimed excipients, contrary to the statements of the Examiner, reiterating the data that discussed above.
These arguments are unpersuasive. "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference .... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413,425 (CCPA 1981) MPEP 2145(III) Jain et al. calls out sodium starch glycolate as a one suitable disintegrant amongst others at ¶ [0064] for the disclosed formulations so such ingredients can be present in formulations other than immediate release formulations and formulations that do not contain sodium starch glycolate but that do contain other disintegrants can be prepared. The data of record does not present any comparisons to demonstrate that the results obtained for the compositions tested in the specification are in fact unexpected and that would be reasonably commensurate in scope with the instant claims.
Regarding Bilge and Wu (note that Wu has been replaced with Huang et al. in the new grounds of rejection below so the arguments regarding Wu are moot), Applicants argue that a patentable invention may lie in the discovery of the source of a problem. Applicants discovered the formation of degradation products such as CTP-543-ZH upon storage of oral dosage forms comprising deuruxolitinib that are undetectable in the claimed dosage forms. None of the cited references disclose the problem or that formation was the result of oxidation and hydrolysis. The degradation product observed in Bilge occurs at a different location than in CTP-543-ZH and nothing about potential degradation products in Applicants dosage form over storage. No motivation to modify or replace excipients is found in this reference.
These arguments are unpersuasive. The amount of any particular degradation product is determined by the ingredients in the compositions and compositions have the required ingredients are rendered obvious as discussed in the November 28, 2025 Office Action and herein. Explicit appreciation that a particular degradation product could form and/or measurement any degradation product is not required to render the instant claims obvious. Bilge et al. and Huang et al. recognized the importance of oxidation in degrading drugs including the non-deuterated form of the drug of the present claims. Based on the explicit, implicit and inherent teachings of the applied prior art and their knowledge, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the instant claims to limit the amount of oxidants such as peroxide that are present in a dosage form of a drug whose non-deuterated form is taught by Bilge et al. to be sensitive to oxidation. One of ordinary skill in the art would reasonably expect the deuterated version that contains the same group that was oxidizes to also be sensitive to oxidation and use excipients such as PVP, known in the art to contain peroxide that can oxidize drugs, that contain low levels of potential oxidants to minimize the amount of drug degradation in the dosage form.
Regarding Rajabi-Siahboomi et al., Applicants argue that this reference fails to cure the deficiencies of the other applied prior art references.
As discussed in greater detail above, the prior art is not deficient as alleged by Applicants for the reasons discussed herein so Rajabi-Siahboomi et al. need not cure the alleged deficiencies.
Comments and Notes
The amendments filed February 27, 2026 are not properly formatted. The Examiner noted that at least “polyvinylpyrrolidone” was deleted from claim 2 but there is no strikethrough indicating this change in the amended claim set. The amendments to the specification indicate replacement of entire paragraphs but with markings indicating changes from the previous version. Since entire paragraphs are to be replaced, such markings should not be used. In the interest of compact prosecution, a Notice of Non-Compliant Amendment is not being mailed but failure to properly format future claim amendments may result in the mailing of a Notice of Non-Compliant Amendment.
Amendments to change the trademark OPADRY® amb II were made to both the specification and claims. No evidence in support of the amendments was provided to establish the contents of the material of this product as of the time of filing to establish that the amendments do introduce new mater. However, in order to examine the amended claims, the Examiner has attempted to determine the material in OPADRY® amb II to reject the claims but such material should have been supplied in the response to demonstrate that no new matter was added to the claims.
Specification
The disclosure was objected to because of the following informalities: the use of the term OPADRY® amb II, which is a trade name or a mark used in commerce, has been noted in this application and all of the requirements for the use of trade names or marks used in commerce have not been met as no generic terminology is present.
Amendments to the specification were filed February 27, 2026 but do not fully address this issue. OPADRY® was capitalized and generic terminology was added to second occurrence in the specification but should at least be added the first time OPADRY® amb II occurs in the specification.
Appropriate correction is still required as all requirements for the use trade names or marks used in commerce have not been fully satisfied.
The amendment filed February 27, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: that OPADRY® amb II is “a polyvinyl alcohol-based film coating comprising polyvinyl alcohol with glycerol monocaprylocaprate”. Those are ingredients appear to be present in OPADRY® amb II but is a broader recitation of what the goods sold under the tradename OPADRY® amb II actually are. Table 2 (¶ [00227] of WO 2021/178406 indicates that Opadry II AMB is composed of polyvinyl alcohol, talc, titanium dioxide, glyceryl monocaprylocaprate and sodium lauryl sulfate.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112 – New Matter
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.
Claim 26 is 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. This is a new matter rejection.
In claim 26, Opadry® amb II was replaced with “polyvinyl-alcohol-based coating” which is a much broader recitation than is supported by the disclosure as originally filed. The only recitation of “polyvinyl alcohol” is ¶ [0090] of the PGPub of the instant application as a possible excipient in a film coating, which does not support that the coating itself is polyvinyl alcohol based. OPADRY® amb II was disclosed but appears to be polyvinyl alcohol, talc, titanium dioxide, glyceryl monocaprylocaprate and sodium lauryl sulfate as disclosed in Table 2 (¶ [00227]) of WO 2021/178406. The new claim language is broader than the disclosure as originally filed and therefore claim 26 contains new matter.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to page and line number wherein support may be found for the instant invention and/or make evidence of record indicating that the full breadth of this limitation is supported by the good sold under the trademark OPADRY® amb II at the time of filing.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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.
Claim 24 was rejected under 35 U.S.C. 103 as being unpatentable over JAKAFI® and Silverman et al. as applied to claims 1, 2 and 11 – 21 above, and further in view of Jain et al. (US 2023/0172863). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
Claim 26 was rejected JAKAFI®, Silverman et al. and Jain et al. further in view of Rajabi-Siahboomi et al. (Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
Rajabi-Siahboomi et al. discloses that Opadry® amb (aqueous moisture barrier) and Opadry® II are two proprietary groups of PVA-based coating systems that have been used in pharmaceutical applications for the last 15 – 20 years (p 406, ¶ 3), reading on the polyvinyl-alcohol based coating of amended claim 26.
Claim(s) 1, 2, 5 and 10 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) in view of Silverman et al. (US 2019/0308976) further in view of Bilge et al. (Electroanalysis, 2023; published online February 11, 2022) and Huang et al. (J Pharm Sci Biomed Anal, 2003).
JAKAFI® discloses tablets for oral administration with ruxolitinib (as the phosphate salt) as the active agent along with the excipients microcrystalline cellulose, lactose monohydrate, povidone (polyvinylpyrrolidone), hydroxypropyl cellulose, colloidal silicon dioxide, sodium starch glycolate, and magnesium stearate (p 29, last paragraph) that together read on a pharmaceutically acceptable carrier. Twice daily dosing at different starting doses depending on the condition being treated is disclosed (Dosage and Administration section on p 1) so the formulation is suitable for twice a day administration.
That the active agent is deuruxolitinib, a deuterated form of ruxolitinib, is not disclosed.
Silverman et al. discloses that many current medicines suffer from poor absorption, distribution, metabolism and/or excretion (ADME) and such poor properties are a major reason for the failure of drug candidates in clinical trials (¶ [0002]). Issues include rapid metabolism that causes the drug to be cleared too rapidly from the body, which can sometimes be solved by frequent or high dosing but this creates additional problems and rapid metabolism can also lead to exposure to undesirable metabolites (¶ [0002]). A potentially attractive strategy to improve metabolic properties is deuterium modification to slow the CYP-mediated metabolism of the drug or reduce undesirable metabolite formation because of the stronger bonds formed with deuterium compared to hydrogen can positively impact ADME properties (¶ [0006]). Ruxolitinib is a known JAK 1/2 (Janus associated kinases) inhibitor (¶ [0009]) with beneficial activity but there is still a need for new compounds (¶ [0013]) and therefore deuterated versions of ruxolitinib are disclosed (e.g., ¶ [0035] onward). Compositions comprising a disclosed compound and pharmaceutically acceptable carriers for compositions are discussed beginning at ¶ [0069]. Compound 111 of claim 1 of Silverman et al. is deuruxolitinib and can be present as the phosphate salt (e.g., claim 10).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use deuruxolitinib as disclosed by Silverman et al. as the therapeutic agent in place of ruxolitinib in the JAKAFI® formulation. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Silverman et al. discloses that deuteration can improve the ADME properties of drugs such as ruxolitinib and deuruxolitinib is specifically claimed.
The peroxide level of the PVP is not disclosed.
Bilge et al. studied the electrochemical behavior of RUX (ruxolitinib) as there was no information on the electrochemical behavior details and oxidation mechanism of RUX (whole document, e.g., p 1318, col 2, ¶ 1) so the electrochemical oxidation process of RUX was studied using a variety of techniques (p 1319, col 1, ¶ 2). Model structures and literature associated with the electroactive rings of RUX were addressed and the leading group present in RUX including the pyrrolopyrimidine ring, demonstrated electrochemical responses, with the authors supposing that the oxidation happens at the pyrrolopyrimidine ring part of the molecule (p 1323, col 2, ¶¶ 2 and 3).
Huang et al. discloses that drug chemical stability can be decreased by impurities in formulation excipients and hydrogen peroxide is an excipient that can oxidize drugs (p 1203). Residual hydrogen peroxide in PVP was shown to be the cause of drug oxidation in a formulation that showed significant degradation in the presence of PVP (p 1203). Table 4 shows the concentration of hydrogen peroxide in ppm in various excipients including PVPs of differing sizes from different manufactures. The amounts ranged from 27 to 188 ppm.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use a low peroxide grade polyvinyl pyrrolidone such as those disclosed by Huang et al. in the deuruxolitinib formulations rendered obvious by JAKAFI® and Silverman et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Bilge et al. discloses that RUX can be oxidized with the pyrrolopyrimidine ring being a likely site of oxidation and Huang et al. discloses that the peroxide in commercially available PVPs can oxidize drugs and contain variable amounts of hydrogen peroxide that can less than about 25 ppm. The use of polyvinyl pyrrolidone with lower levels of peroxide would reasonably be expected to lower the amount of deuruxolitinib oxidation that could potentially occur due to peroxide present in the PVP. There is no evidence of record as to the criticality of the claimed ranges for the amount of peroxide present in the PVP.
No mention is made of the level of impurities such as the degradation product CTP-543-ZH. This is a deuterated compound so could not be present in JAKAFI® but the same oxidation of the pyrollopyrimidine ring portion of the compound could still occur. One of ordinary skill in the art is aware that degradation products of the therapeutic agent can decrease the amount of therapeutic agent present in a formulation and/or potentially can contribute to unwanted side effects when administered. The amount of degradation products present in a formulation are affected by the structure of the compound potentially subject to degradation and the excipients present in the formulation. This rejection renders obvious the presence of deuruxolitinib in an oral dosage with highly similar excipients as claimed in a tablet formulation. There is no evidence of record that such a formulation results in levels of CTP-543-ZH that exceed the limits set forth in claim. One of ordinary skill in the art would optimize the formulations to minimize the formation of such degradation products and the formulation of an already approved product for non-deuterated ruxolitinib would form a starting point for such formulations.
Claim(s) 1 – 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over JAKAFI® (ruxolitinib) tablets for oral use label, Silverman et al., Bilge et al. and Huang et al. as applied to claims 1, 2, 5 and 10 – 21 above, and further in view of Jain et al. (US 2023/0172863).
JAKAFI® (ruxolitinib) tablets for oral use label, Silverman et al., Bilge et al. and Huang et al. are discussed above.
Weight percents for the various excipients are not disclosed. Formulations that do not contain sodium starch glycolate are also not disclosed.
Jain et al. discloses a modified release pharmaceutical composition of ruxolitinib or salts thereof (whole document, e.g., abstract). In a preferred embodiment the formulation is tablet (¶ [0071]). The disclosed compositions can in some embodiments have a level of total impurities being less than 1.5% w/w when stored at 40°C/75% RH (relative humidity)/25°C/60% RH for at least 3 months (¶ [0021]), indicating an awareness of impurity levels in the final product as a parameter to assay. Ruxolitinib, polyethylene oxide and optionally microcrystalline cellulose can be present in an intra-granular phase with the extra-granular phase containing at least one additional excipient selected from diluents, binders, chelating agents, coating agents, disintegrating agents, lubricants, glidants, colorants, surfactant, plasticizers and mixtures thereof such as magnesium stearate as the lubricant (¶¶ [0024] – [0026]). Diluents such as microcrystalline cellulose and lactose (¶ [0027]) can be present in amounts ranging from about 60% to about 95% of the total composition (¶ [0028]) although a broad range of about 5% to about 95% w/w is also disclosed (¶ [0062]). Binders such as hydroxypropyl cellulose, PVP or microcrystalline cellulose can be used to increase the cohesion of the granules during granulation and can be present in the intragranular phase or in the granulating fluids with disclosed amounts being about 1% to about 50% and about 10% to about 30% w/w of the total composition (¶ [0063]). Disintegrants wick and/or swell in the presence of water and suitable disintegrating agents disclosed include low substituted hydroxypropyl cellulose and sodium starch glycollate with disclosed amounts being about 1% to about 50% and about 5% to about 30% w/w of the total composition (¶ [0064]). Lubricants such as magnesium stearate have disclosed amounts of about 0.01% to about 10% and about 0.5% to about 5% w/w of the total composition (¶ [0065]). The pharmaceutical composition may be optionally coated such as using a commercially available coating such as those marketed under tradenames such as OPADRY® (¶ [0070]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the guidance of Jain et al. as to the amounts of various excipients present in ruxolitinib formulations to prepare an optimized formulation of deuruxolitinib and the excipients present in a known formulation such as JAKAFI®. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the selection of particular excipients, the location (e.g., intragranular or extragranular) and amount of a specific ingredient in a composition are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize based on their knowledge and the materials, locations and general ranges disclosed in the prior art. Some excipients can serve multiple purposes which can alter the overall amount of those ingredients and/or reduce the amounts of other ingredients in the formulation with the same purpose (e.g., microcrystalline cellulose is taught as both a diluent and a binder). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) MPEP 2144.05 “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the selected excipients and/or amounts of the excipients present in the formulation.
As to claim 9, sodium starch glycolate is one amongst a list of disintegrants disclosed by Jain et al. and it would have been obvious, absent evidence of unexpected results, to replace the sodium starch glycolate of JAKAFI® with a different disintegrant taught by Jain et al. Therefore formulations that do not contain sodium starch glycolate are not patentably distinguished over those of the prior art.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Regarding the various double patenting rejections set forth below, Applicants argue the additional prior art documents do not teach or suggest the claimed dosage forms.
These arguments are unpersuasive. No amendment was made to claim 24 so those rejections are maintained for the reasons of record as there in no limitation on the peroxide content of the PVP. Rajabi-Siahboomi et al. discloses that Opadry® amb (aqueous moisture barrier) and Opadry® II are two proprietary groups of PVA-based coating systems that have been used in pharmaceutical applications for the last 15 – 20 years (p 406, ¶ 3), reading on the polyvinyl-alcohol based coating of amended claim 26. The arguments regarding JAKAFI®, Silverman, Jain and Bilge are discussed herein with new grounds of rejection for claims 1 – 21, 25 and 26 are set forth below to render the amount of peroxide in the PVP obvious based on the teachings of Huang et al.
Claims 24 and 26 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 14 of U.S. Patent No. 12,247,034 optionally in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) and Jain et al. (US 2023/0172863) optionally in view of Rajabi-Siahboomi et al. (Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
Claims 24 and 26 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 - 21 of copending Application No. 18/078,571 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) and Jain et al. (US 2023/0172863) in view of Rajabi-Siahboomi et al. (Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 24 and 26 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12 and 14 - 23 of copending Application No. 18/666,084 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) and Jain et al. (US 2023/0172863) in view of Rajabi-Siahboomi et al. (Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 24 and 26 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 - 55 of copending Application No. 19/046,253 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) and Jain et al. (US 2023/0172863) in view of Rajabi-Siahboomi et al. (Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 24 and 26 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29 - 56 of copending Application No. 19/088,476 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023), Silverman et al. (US 2019/0308976) and Jain et al. (US 2023/0172863) in view of Rajabi-Siahboomi et al. (Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed November 28, 2025 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 21 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 14 of U.S. Patent No. 12,247,034 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) in view of Bilge et al. (Electroanalysis, 2023; published online February 11, 2022) and Huang et al. (J Pharm Sci Biomed Anal, 2003) and optionally further in view of Jain et al. (US 2023/0172863).
The claims of US’034 recite a polymorph of deuruxolitinib phosphate (claim 1) and a pharmaceutical composition thereof that also comprise a pharmaceutically acceptable carrier (claim 14).
Specific pharmaceutically acceptable carriers are not claimed.
JAKAFI® (ruxolitinib) tablets for oral use label, Bilge et al., Huang et al. and Jain et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the tablet formulation of JAKAFI® for the active agents claimed by US’034. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because JAKAFI® provides an approved tablet formulation for the non-deuterated version of ruxolitinib. The selection of particular excipients, the location (e.g., intragranular or extragranular) and amount of a specific ingredient in a composition are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize based on their knowledge and the materials, locations and general ranges disclosed in the prior art. Some excipients can serve multiple purposes which can alter the overall amount of those ingredients and/or reduce the amounts of other ingredients in the formulation with the same purpose (e.g., microcrystalline cellulose is taught as both a diluent and a binder by Jain et al.). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) MPEP 2144.05 “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the selected excipients and/or amounts of the excipients present in the formulation.
Bilge et al. and Huang et al. provide motivation to select a low peroxide grade polyvinyl pyrrolidone to reduce the amount of peroxide present in this excipient used in the formulation that would reasonably be expected to lower the amount of deuruxolitinib oxidation due to the peroxide present in commercially available PVPs. Commerically available PVPs contain variable amounts of hydrogen peroxide that can less than about 25 ppm.
While the claims are silent as to the amount of CTP-543-ZH present in the composition, there is no evidence of record that such formulations inherently contain amounts of CTP-543-ZH, a degradation product of deuruxolitinib (see ¶ [00068] of the instant specification as filed), that exceed the limitation of instant claim 1. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
As to claim 9, sodium starch glycolate is one amongst a list of disintegrants disclosed by Jain et al. and it would have been obvious, absent evidence of unexpected results, to replace the sodium starch glycolate of JAKAFI® with a different disintegrant taught by Jain et al. Therefore formulations that do not contain sodium starch glycolate are not patentably distinguished over those of the prior art.
Claims 1 – 21 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 - 21 of copending Application No. 18/078,571 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) in view of Bilge et al. (Electroanalysis, 2023; published online February 11, 2022) and Huang et al. (J Pharm Sci Biomed Anal, 2003) and optionally further in view of Jain et al. (US 2023/0172863).
The claims of US’571 recite deuruxolitinib or a pharmaceutically acceptable salt thereof (claim 10) that can be the phosphate sale (e.g., claim 11). Pharmaceutical compositions that comprise the compound of claim 10, such as the phosphate sale (claim 11) in combination with a pharmaceutically acceptable carrier are also claimed (claim 16).
Specific pharmaceutically acceptable carriers are not claimed.
JAKAFI® (ruxolitinib) tablets for oral use label, Bilge et al., Huang et al. and Jain et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the tablet formulation of JAKAFI® for the active agents claimed by US’571. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because JAKAFI® provides an approved tablet formulation for the non-deuterated version of ruxolitinib. The selection of particular excipients, the location (e.g., intragranular or extragranular) and amount of a specific ingredient in a composition are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize based on their knowledge and the materials, locations and general ranges disclosed in the prior art. Some excipients can serve multiple purposes which can alter the overall amount of those ingredients and/or reduce the amounts of other ingredients in the formulation with the same purpose (e.g., microcrystalline cellulose is taught as both a diluent and a binder by Jain et al.). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) MPEP 2144.05 “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the selected excipients and/or amounts of the excipients present in the formulation.
Bilge et al. and Huang et al. provide motivation to select a low peroxide grade polyvinyl pyrrolidone to reduce the amount of peroxide present in this excipient used in the formulation that would reasonably be expected to lower the amount of deuruxolitinib oxidation due to the peroxide present in commercially available PVPs. Commerically available PVPs contain variable amounts of hydrogen peroxide that can less than about 25 ppm.
While the claims are silent as to the amount of CTP-543-ZH present in the composition, there is no evidence of record that such formulations inherently contain amounts of CTP-543-ZH, a degradation product of deuruxolitinib (see ¶ [00068] of the instant specification as filed), that exceed the limitation of instant claim 1. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
As to claim 9, sodium starch glycolate is one amongst a list of disintegrants disclosed by Jain et al. and it would have been obvious, absent evidence of unexpected results, to replace the sodium starch glycolate of JAKAFI® with a different disintegrant taught by Jain et al. and some ingredients can serve multiple functions in a formulation (e.g., microcrystalline cellulose and hydroxypropyl celluloses are listed under different types of excipients). Therefore formulations that do not contain sodium starch glycolate are not patentably distinguished over those of the prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 21 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12 and 14 - 23 of copending Application No. 18/666,084 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) in view of Bilge et al. (Electroanalysis, 2023; published online February 11, 2022) and Huang et al. (J Pharm Sci Biomed Anal, 2003) and optionally further in view of Jain et al. (US 2023/0172863).
The claims of US’084 recite product by process claims that result in the production of deuterated compounds such as deuruxolitinib when Y1 is hydrogen and all of Y2 and Y3 are deuterium (e.g., claim 1) and when phosphoric acid is used as the acid (claim 2), at least some phosphate salt will be present in the product. Similarly, when hydrated tripotassium phosphate is used as the base in the production process for the products of claims 22 and 23, at least some phosphate salt will be present in the product.
Specific pharmaceutically acceptable carriers are not claimed.
JAKAFI® (ruxolitinib) tablets for oral use label, Bilge et al., Huang et al. and Jain et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the tablet formulation of JAKAFI® for the active agents claimed by US’084. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because JAKAFI® provides an approved tablet formulation for the non-deuterated version of ruxolitinib. The selection of particular excipients, the location (e.g., intragranular or extragranular) and amount of a specific ingredient in a composition are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize based on their knowledge and the materials, locations and general ranges disclosed in the prior art. Some excipients can serve multiple purposes which can alter the overall amount of those ingredients and/or reduce the amounts of other ingredients in the formulation with the same purpose (e.g., microcrystalline cellulose is taught as both a diluent and a binder by Jain et al.). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) MPEP 2144.05 “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the selected excipients and/or amounts of the excipients present in the formulation.
Bilge et al. and Huang et al. provide motivation to select a low peroxide grade polyvinyl pyrrolidone to reduce the amount of peroxide present in this excipient used in the formulation that would reasonably be expected to lower the amount of deuruxolitinib oxidation due to the peroxide present in commercially available PVPs. Commerically available PVPs contain variable amounts of hydrogen peroxide that can less than about 25 ppm.
While the claims are silent as to the amount of CTP-543-ZH present in the composition, there is no evidence of record that such formulations inherently contain amounts of CTP-543-ZH, a degradation product of deuruxolitinib (see ¶ [00068] of the instant specification as filed), that exceed the limitation of instant claim 1. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
As to claim 9, sodium starch glycolate is one amongst a list of disintegrants disclosed by Jain et al. and it would have been obvious, absent evidence of unexpected results, to replace the sodium starch glycolate of JAKAFI® with a different disintegrant taught by Jain et al. Therefore formulations that do not contain sodium starch glycolate are not patentably distinguished over those of the prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 21 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27 - 55 of copending Application No. 19/046,253 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) in view of Bilge et al. (Electroanalysis, 2023; published online February 11, 2022) and Huang et al. (J Pharm Sci Biomed Anal, 2003) and optionally further in view of Jain et al. (US 2023/0172863).
The claims of US’253 recite the use of a particular polymorph of deuruxolitinib phosphate in a method of treating a disease associated with JAKs in a subject (e.g., claim 27).
While the compound must be administered, the presence of a pharmaceutically carrier that is almost universally used when administering therapeutic agents to a patient is not specifically claimed.
JAKAFI® (ruxolitinib) tablets for oral use label, Bilge et al., Huang et al. and Jain et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the tablet formulation of JAKAFI® for the active agents claimed by US’253. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because JAKAFI® provides an approved tablet formulation for the non-deuterated version of ruxolitinib. The selection of particular excipients, the location (e.g., intragranular or extragranular) and amount of a specific ingredient in a composition are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize based on their knowledge and the materials, locations and general ranges disclosed in the prior art. Some excipients can serve multiple purposes which can alter the overall amount of those ingredients and/or reduce the amounts of other ingredients in the formulation with the same purpose (e.g., microcrystalline cellulose is taught as both a diluent and a binder by Jain et al.). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) MPEP 2144.05 “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the selected excipients and/or amounts of the excipients present in the formulation.
Bilge et al. and Huang et al. provide motivation to select a low peroxide grade polyvinyl pyrrolidone to reduce the amount of peroxide present in this excipient used in the formulation that would reasonably be expected to lower the amount of deuruxolitinib oxidation due to the peroxide present in commercially available PVPs. Commerically available PVPs contain variable amounts of hydrogen peroxide that can less than about 25 ppm.
While the claims are silent as to the amount of CTP-543-ZH present in the composition, there is no evidence of record that such formulations inherently contain amounts of CTP-543-ZH, a degradation product of deuruxolitinib (see ¶ [00068] of the instant specification as filed), that exceed the limitation of instant claim 1. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
As to claim 9, sodium starch glycolate is one amongst a list of disintegrants disclosed by Jain et al. and it would have been obvious, absent evidence of unexpected results, to replace the sodium starch glycolate of JAKAFI® with a different disintegrant taught by Jain et al. Therefore formulations that do not contain sodium starch glycolate are not patentably distinguished over those of the prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 21 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29 - 56 of copending Application No. 19/088,476 in view of JAKAFI® (ruxolitinib) tablets for oral use label (revised January 2023) in view of Silverman et al. (US 2019/0308976), Bilge et al. (Electroanalysis, 2023; published online February 11, 2022) and Huang et al. (J Pharm Sci Biomed Anal, 2003) and optionally further in view of Jain et al. (US 2023/0172863).
The claims of US’476 recite a method of treating one of the three types of alopecia by the oral administration of deuruxolitinib or a pharmaceutically acceptable salt thereof to a human subject along with two different CYP3A4 inhibitors (claim 29).
The phosphate salt and particular excipients are not claimed even though the presence of a pharmaceutically carrier that is almost universally when administering therapeutic agents to a subject.
JAKAFI® (ruxolitinib) tablets for oral use label, Silverman et al., Bilge et al., Huang et al. and Jain et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the tablet formulation of JAKAFI® for the active agents claimed by US’476. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because JAKAFI® provides an approved tablet formulation for the non-deuterated version of ruxolitinib phosphate. The selection of particular excipients, the location (e.g., intragranular or extragranular) and amount of a specific ingredient in a composition are clearly result effective parameters that a person of ordinary skill in the art would routinely optimize based on their knowledge and the materials, locations and general ranges disclosed in the prior art. Some excipients can serve multiple purposes which can alter the overall amount of those ingredients and/or reduce the amounts of other ingredients in the formulation with the same purpose (e.g., microcrystalline cellulose is taught as both a diluent and a binder by Jain et al.). Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) MPEP 2144.05 “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the selected excipients and/or amounts of the excipients present in the formulation.
Bilge et al. and Huang et al. provide motivation to select a low peroxide grade polyvinyl pyrrolidone to reduce the amount of peroxide present in this excipient used in the formulation that would reasonably be expected to lower the amount of deuruxolitinib oxidation due to the peroxide present in commercially available PVPs. Commerically available PVPs contain variable amounts of hydrogen peroxide that can less than about 25 ppm.
While the claims are silent as to the amount of CTP-543-ZH present in the composition, there is no evidence of record that such formulations inherently contain amounts of CTP-543-ZH, a degradation product of deuruxolitinib (see ¶ [00068] of the instant specification as filed), that exceed the limitation of instant claim 1. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
As to claim 9, sodium starch glycolate is one amongst a list of disintegrants disclosed by Jain et al. and it would have been obvious, absent evidence of unexpected results, to replace the sodium starch glycolate of JAKAFI® with a different disintegrant taught by Jain et al. Therefore formulations that do not contain sodium starch glycolate are not patentably distinguished over those of the prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618