Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2025 has been entered.
Current Status of 17/417,712
The rejections of record have been maintained below.
The elected species read on claims 6, 8-9, 11-15, and 17-19.
Claims 6, 8-9, 11-15, 17-19 and 29-36 have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/CN2019/127837 (filed 12/24/2019) and claims foreign priority to CN20191067929.0 (filed 7/26/2019) and claims foreign priority to CN201811581815.8 (filed 12/24/2018).
The instant claims find support from CN201811581815.8. The effective filing daet is 12/24/2018.
Response to Arguments
Applicants’ claim amendments and Remarks of 8/20/2025 are acknowledged and have been considered.
Applicants have amended claim 6 to further define compound of formula I.
The obviousness rejection is maintained. Applicants’ arguments with Examiner’s reply are summarized below:
ZHU fails to disclose any specific solid pharmaceutical compositions, let alone its technical effects.
If the composition is obvious, then its technical effects are an inherent property. In re Spada, from MPEP 2112.01, teaches that “Products of identical chemical composition can not have mutually exclusive properties.” Additionally, There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. See MPEP 2112.(II).
The compound of formula I exhibits poorer water solubility compared to Baricitinib, making it more difficult to dissolve. Therefore, an artisan would not have been motivated by HAN.
Applicants submit that the instant pharmaceutical composition has unexpected beneficial effects I solubility and stability.
Examples 2, 4, and 5 have been reviewed. Examiner is unsure if the data is unexpected.
Applicants submit that the Examiner should accept the data as unexpected results because other foreign offices have not raised objections regarding the validity of the unexpected results.
What other foreign patent offices do will not influence USPTO.
Applicants submit supplementary data to further show that sodium dodecyl sulfate has a better effect on improving dissolution rate compared to tween 80 in declaration of Chen Li.
Examiner has reviewed the declaration. Said declaration is compliant and therefore formally entered into record. The declaration is timely filed, signed by the inventor (Chen Li) and includes a reference to 18 U.S.C. 1001.
The results are not commensurate in scope with the instant claim. Formulations J and K contain “formula II” whereas the instant claims have a compound of formula I.
The instant claims allow for a diluent selected from microcrystalline cellulose, mannitol, or a mixture thereof. The instant claims allow for a binder selected from hydroxypropyl cellulose, polyvinylpyrrolidone, or a mixture thereof. The instant claims allow for a wetting agent selected from sodium dodecyl sulfate, magnesium dodecyl sulfate or a mixture thereof. The instant claims allow for a disintegrant selected from sodium carboxymethyl starch, croscarmellose sodium, or a mixture thereof.
Additionally, both formulations J and K contain magnesium stearate, which is not a component allowed by the instant claim.
Moreover, Applicant is reminded that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
Formulations J and K both show effective dissolution rates over time. Both have incremental improvements.
DAVE, cited previously, teaches that wetting agents are essential components (page 1). Additionally, it is known as seen in MARKL that improving poor solubility is addressed by selecting an appropriate agent like glidants, lubricants (i.e. wetting agents) or surfactants (Markl et Zeitler, “A Review of Disintegration Mechanisms and Measurement Techniques”, Pharm Res, March 1, 2017; page 891 right col, Figure 13, page 903 right col.).
An artisan would be motivated to modify/substitute one wetting agent for another. See MPEP 2144.06(II).
Applicants submit a declaration of Dong Wang under 37 CFR 1.132, to show that the instant compound has excellent clinical therapeutic effects.
Examiner has reviewed the declaration. Said declaration is compliant and therefore formally entered into record. The declaration is timely filed, signed by the inventor (Dong Wang) and includes a reference to 18 U.S.C. 1001.
Said declaration shows that rovadicitinib is effective in a phase I/Ib trial (NCT04339400).
Applicant is reminded that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
This is not commensurate in scope. Rovadicitinib is a compound. The instant claims are drawn to a composition.
Response to amendment
Claim Rejections - 35 USC § 103-MAINTAINED
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.
Claim(s) 6, 8-9, 11-15, 17-19 and 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over:
ZHU (WO 2017101777)
In view of
HAN (CN 107334738)
in view of
DAVE (Dave, “Overview of pharmaceutical excipients used in tablets and capsules”, October 24, 2008),
And in view of
SIGMA (“Sodium Dodecyl Sulfate”, Sigma, Jan 21, 2014)
ZHU teaches the compound in claim 19
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(reference claim 1 and claim 10). This teaches the compound of claims 6 and 19.
ZHU also teaches that this compound can be made into a pharmaceutical composition (technical field).
HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 parts of Baricitinib, 46 parts of microcrystalline cellulose (elected species of diluent), 46 parts of mannitol (elected species of diluent), 3 parts of croscarmellose sodium (species of disintegrant) and 1 part of magnesium stearate.
DAVE teaches “Apart from the drug’s active ingredient, other essential components include diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives. Diluents or fillers are inert ingredients that can significantly affect the chemical and physical properties of the final tablet thus affecting the biopharmaceutical profile.” (page 1).
DAVE teaches that “Binders are usually selected on basis of previous experience, particular product needs, literature or vendor data or the preference of individual scientists or manufacturing unit. The primary criterion when choosing a binder is its compatibility with other tablet components” (page 1).
DAVE teaches Hydroxy propyl cellulose (the elected species of binder) is a known binder (page 10).
SIGNMA teaches that sodium dodecyl sulfate (elected species of wetting agent) as a wetting agent (page 1).
SDS has a wide variety of applications, but is most often used as a protein and lipid solubilization reagent (SIGMA page 1).
The skilled artisan would find it obvious before the effective filing date of the claimed invention to add a pharmaceutically acceptable diluent, binder, wetting agent and disintegrant to compound in claim 19
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(ZAN claim 1). The artisan would have been motivated by ZHU’s teachings that this compound can be made into a pharmaceutical composition (technical field). The artisan would have expected to use a known pharmaceutical tablet such as HAN’s (embodiment 2).
DAVE teaches other essential components (including diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives) (page 1). An artisan would have been motivated to add these components in order to affect the chemical and physical properties of the final tablet thus improve the biopharmaceutical profile of the final product (DAVE page 1). The artisan would have been motivated and expected to use a known binder such as Hydroxy propyl cellulose (DAVE page 10). The artisan would have been motivated to add a known wetting agent such as sodium dodecyl sulfate in order to improve the protein and lipid solubilization reagent (SIGMA page 1). This teaches claim 6.
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 wt% active ingredient, 46 wt% of microcrystalline cellulose (elected species of diluent), 46 wt% of mannitol (elected species of diluent), 3 wt% of croscarmellose sodium (species of disintegrant) and 1 wt% of magnesium stearate. The artisan would have been motivated to optimize the pharmacokinetics (DAVE page 1). See MPEP 2144.05 (II)(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the weight percentages of the components in the instant claims is critical. This teaches 6, 8-9, 11-15, and 17-19. This also teaches new claims 29-36.
Double Patenting- MAINTAINED
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.
Claims 6, 8-9, 11-15, 17-19, and 29-36 are rejected on the ground of nonstatutory obviousness type double patenting as being unpatentable over claim 13 of U.S. Patent No. US 10766901. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the compounds are the same.
Claim 13 (in view of claim 2) teaches the elected compound. US 10766901 does not teach a pharmaceutical composition, but is does teach the reference compounds use as JAK inhibitors and cancer treatments (background/summary of invention).
HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 parts of Baricitinib, 46 parts of microcrystalline cellulose (elected species of diluent), 46 parts of mannitol (elected species of diluent), 3 parts of croscarmellose sodium (species of disintegrant) and 1 part of magnesium stearate.
DAVE teaches “Apart from the drug’s active ingredient, other essential components include diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives. Diluents or fillers are inert ingredients that can significantly affect the chemical and physical properties of the final tablet thus affecting the biopharmaceutical profile.” (page 1).
DAVE teaches that “Binders are usually selected on basis of previous experience, particular product needs, literature or vendor data or the preference of individual scientists or manufacturing unit. The primary criterion when choosing a binder is its compatibility with other tablet components” (page 1).
DAVE teaches Hydroxy propyl cellulose (the elected species of binder) is a known binder (page 10).
SIGNMA teaches that sodium dodecyl sulfate (elected species of wetting agent) as a wetting agent (page 1).
SDS has a wide variety of applications, but is most often used as a protein and lipid solubilization reagent (SIGMA page 1).
The skilled artisan would find it obvious before the effective filing date of the claimed invention to add a pharmaceutically acceptable diluent, binder, wetting agent and disintegrant to compound in claim 19
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(reference claims 2 and 13). The artisan would have been motivated by ZHU’s teachings that this compound can be made into a pharmaceutical composition (technical field). The artisan would have expected to use a known pharmaceutical tablet such as HAN’s (embodiment 2).
DAVE teaches other essential components (including diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives) (page 1). An artisan would have been motivated to add these components in order to affect the chemical and physical properties of the final tablet thus improve the biopharmaceutical profile of the final product (DAVE page 1). The artisan would have been motivated and expected to use a known binder such as Hydroxy propyl cellulose (DAVE page 10). The artisan would have been motivated to add a known wetting agent such as sodium dodecyl sulfate in order to improve the protein and lipid solubilization reagent (SIGMA page 1). This teaches claim 6.
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 wt% active ingredient, 46 wt% of microcrystalline cellulose (elected species of diluent), 46 wt% of mannitol (elected species of diluent), 3 wt% of croscarmellose sodium (species of disintegrant) and 1 wt% of magnesium stearate. The artisan would have been motivated to optimize the pharmacokinetics (DAVE page 1). See MPEP 2144.05 (II)(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the weight percentages of the components in the instant claims is critical. This teaches claims 6, 8-9, 11-15, 17-19, and 29-36.
Claims 6, 8-9, 11-15, 17-19, and 29-36 are rejected on the ground of nonstatutory obviousness type double patenting as being unpatentable over claims 9 and 16 of U.S. Patent No. US 10561657. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the compounds are the same.
Claim 9 teaches the elected compound.
Claim 16 teaches a pharmaceutical composition including carriers or excipients.
HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 parts of Baricitinib, 46 parts of microcrystalline cellulose (elected species of diluent), 46 parts of mannitol (elected species of diluent), 3 parts of croscarmellose sodium (species of disintegrant) and 1 part of magnesium stearate.
DAVE teaches “Apart from the drug’s active ingredient, other essential components include diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives. Diluents or fillers are inert ingredients that can significantly affect the chemical and physical properties of the final tablet thus affecting the biopharmaceutical profile.” (page 1).
DAVE teaches that “Binders are usually selected on basis of previous experience, particular product needs, literature or vendor data or the preference of individual scientists or manufacturing unit. The primary criterion when choosing a binder is its compatibility with other tablet components” (page 1).
DAVE teaches Hydroxy propyl cellulose (the elected species of binder) is a known binder (page 10).
SIGNMA teaches that sodium dodecyl sulfate (elected species of wetting agent) as a wetting agent (page 1).
SDS has a wide variety of applications, but is most often used as a protein and lipid solubilization reagent (SIGMA page 1).
The skilled artisan would find it obvious before the effective filing date of the claimed invention to add a pharmaceutically acceptable diluent, binder, wetting agent and disintegrant to compound in claim 19
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(reference claims 2 and 13). The artisan would have been motivated by ZHU’s teachings that this compound can be made into a pharmaceutical composition (technical field). The artisan would have expected to use a known pharmaceutical tablet such as HAN’s (embodiment 2).
DAVE teaches other essential components (including diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives) (page 1). An artisan would have been motivated to add these components in order to affect the chemical and physical properties of the final tablet thus improve the biopharmaceutical profile of the final product (DAVE page 1). The artisan would have been motivated and expected to use a known binder such as Hydroxy propyl cellulose (DAVE page 10). The artisan would have been motivated to add a known wetting agent such as sodium dodecyl sulfate in order to improve the protein and lipid solubilization reagent (SIGMA page 1). This teaches claim 6.
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 wt% active ingredient, 46 wt% of microcrystalline cellulose (elected species of diluent), 46 wt% of mannitol (elected species of diluent), 3 wt% of croscarmellose sodium (species of disintegrant) and 1 wt% of magnesium stearate. The artisan would have been motivated to optimize the pharmacokinetics (DAVE page 1). See MPEP 2144.05 (II)(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the weight percentages of the components in the instant claims is critical. This teaches 6, 8-9, 11-15, and 17-19.
Claims 6, 8-9, 11-15, 17-19, and 29-36 are rejected on the ground of nonstatutory anticipatory type double patenting as being unpatentable over claim 1 of U.S. PG Pub 20240285635. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the compounds are the same.
Claim 1 teaches a pharmaceutical composition including carriers or excipients (used in a method).
HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 parts of Baricitinib, 46 parts of microcrystalline cellulose (elected species of diluent), 46 parts of mannitol (elected species of diluent), 3 parts of croscarmellose sodium (species of disintegrant) and 1 part of magnesium stearate.
DAVE teaches “Apart from the drug’s active ingredient, other essential components include diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives. Diluents or fillers are inert ingredients that can significantly affect the chemical and physical properties of the final tablet thus affecting the biopharmaceutical profile.” (page 1).
DAVE teaches that “Binders are usually selected on basis of previous experience, particular product needs, literature or vendor data or the preference of individual scientists or manufacturing unit. The primary criterion when choosing a binder is its compatibility with other tablet components” (page 1).
DAVE teaches Hydroxy propyl cellulose (the elected species of binder) is a known binder (page 10).
SIGNMA teaches that sodium dodecyl sulfate (elected species of wetting agent) as a wetting agent (page 1).
SDS has a wide variety of applications, but is most often used as a protein and lipid solubilization reagent (SIGMA page 1).
The skilled artisan would find it obvious before the effective filing date of the claimed invention to add a pharmaceutically acceptable diluent, binder, wetting agent and disintegrant to compound in claim 19
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(reference claims 2 and 13). The artisan would have been motivated by ZHU’s teachings that this compound can be made into a pharmaceutical composition (technical field). The artisan would have expected to use a known pharmaceutical tablet such as HAN’s (embodiment 2).
DAVE teaches other essential components (including diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives) (page 1). An artisan would have been motivated to add these components in order to affect the chemical and physical properties of the final tablet thus improve the biopharmaceutical profile of the final product (DAVE page 1). The artisan would have been motivated and expected to use a known binder such as Hydroxy propyl cellulose (DAVE page 10). The artisan would have been motivated to add a known wetting agent such as sodium dodecyl sulfate in order to improve the protein and lipid solubilization reagent (SIGMA page 1). This teaches claim 6.
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 wt% active ingredient, 46 wt% of microcrystalline cellulose (elected species of diluent), 46 wt% of mannitol (elected species of diluent), 3 wt% of croscarmellose sodium (species of disintegrant) and 1 wt% of magnesium stearate. The artisan would have been motivated to optimize the pharmacokinetics (DAVE page 1). See MPEP 2144.05 (II)(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the weight percentages of the components in the instant claims is critical. This teaches Claims 6, 8-9, 11-15, 17-19, and 29-36.
Claims 6, 8-9, 11-15, 17-19, and 29-36 are rejected on the ground of nonstatutory anticipatory type double patenting as being unpatentable over claims 1, 6 of U.S. PG Pub 20230133735. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the compounds are the same.
Claims 1 and 6 teaches a pharmaceutical composition including carriers or excipients (used in a method).
HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 parts of Baricitinib, 46 parts of microcrystalline cellulose (elected species of diluent), 46 parts of mannitol (elected species of diluent), 3 parts of croscarmellose sodium (species of disintegrant) and 1 part of magnesium stearate.
DAVE teaches “Apart from the drug’s active ingredient, other essential components include diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives. Diluents or fillers are inert ingredients that can significantly affect the chemical and physical properties of the final tablet thus affecting the biopharmaceutical profile.” (page 1).
DAVE teaches that “Binders are usually selected on basis of previous experience, particular product needs, literature or vendor data or the preference of individual scientists or manufacturing unit. The primary criterion when choosing a binder is its compatibility with other tablet components” (page 1).
DAVE teaches Hydroxy propyl cellulose (the elected species of binder) is a known binder (page 10).
SIGNMA teaches that sodium dodecyl sulfate (elected species of wetting agent) as a wetting agent (page 1).
SDS has a wide variety of applications, but is most often used as a protein and lipid solubilization reagent (SIGMA page 1).
The skilled artisan would find it obvious before the effective filing date of the claimed invention to add a pharmaceutically acceptable diluent, binder, wetting agent and disintegrant to compound in claim 19
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(reference claims 2 and 13). The artisan would have been motivated by ZHU’s teachings that this compound can be made into a pharmaceutical composition (technical field). The artisan would have expected to use a known pharmaceutical tablet such as HAN’s (embodiment 2).
DAVE teaches other essential components (including diluents or fillers, binders, disintegrants, lubricants (i.e. wetting agents), coloring agents and preservatives) (page 1). An artisan would have been motivated to add these components in order to affect the chemical and physical properties of the final tablet thus improve the biopharmaceutical profile of the final product (DAVE page 1). The artisan would have been motivated and expected to use a known binder such as Hydroxy propyl cellulose (DAVE page 10). The artisan would have been motivated to add a known wetting agent such as sodium dodecyl sulfate in order to improve the protein and lipid solubilization reagent (SIGMA page 1). This teaches claim 6.
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. HAN teaches a prescription (pharmaceutical composition) for baricitinib tablets (embodiment 2), which contains 4 wt% active ingredient, 46 wt% of microcrystalline cellulose (elected species of diluent), 46 wt% of mannitol (elected species of diluent), 3 wt% of croscarmellose sodium (species of disintegrant) and 1 wt% of magnesium stearate. The artisan would have been motivated to optimize the pharmacokinetics (DAVE page 1). See MPEP 2144.05 (II)(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the weight percentages of the components in the instant claims is critical. This teaches Claims 6, 8-9, 11-15, 17-19, and 29-36.
Conclusion
No claims are allowed.
US 10617692 is not a double patent because one of the R1-R4 has to be something other than H.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625