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 .
Current Status of 17/417,712
Some of the rejections of record have been maintained below. New rejections due to amendments have been made below.
Claims 6, 8-9, 11-15, 17-19, 29-36, and 40 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 date is 12/24/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicants’ claim amendments and Remarks of 03/27/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the obviousness rejection, this rejection is withdrawn. Applicants have amended base claim 6. Applicants remarks with Examiner’s reply are summarized below:
ZHU does not disclose any specific solid pharmaceutical compositions.
The structures of Baricitinib and compounds of Formula II are distinct (HAN); the structural differences of these compounds result in different excipients would be chosen.
HAN teaches wetting agents as an optional component.
HAN teaches microcrystalline cellulose may act as binder, but does not require said binder.
DAVE teaches that lubricants (i.e. wetting agents) may decrease the drug dissolution rate; while, the instant composition demonstrates an unexpected increased in drug dissolution rate.
Applicants submit that the instant pharmaceutical composition has unexpected beneficial effects of solubility and stability.
Examiner has reviewed Examples 2, 4, and 5 from the instant specification. Compositions with a wetting agent have good dissolution results (e.g. cumulative dissolutions after 30 mins are > 90%); while, compositions without a wetting agent do not have good dissolution results (e.g. cumulative dissolutions after 30 mins are <70%) (tables 7 and 8).
The Inventor’s Declaration shows that Formula J (which contains Sodium Dodecyl Sulfate) has a better effect on improving the dissolution rate, compared to Tween 80 (Formulation K).
Examiner has reviewed the declaration. This was previously discussed in the Nonfinal rejection of 09/29/2025.
Applicants submit another declaration by Chen Li, which shows dissolution characterization tests for 5 and 20 mg tablets as disclosed in example 2 and dissolution characterization tests for formulations A-I from example 5, and dissolution characterization tests formulations J and K (closest prior art test).
Chen Li declares that the of formula J with sodium dodecyl sulfate (table 5, and paragraph 13 of the declaration of 03/27/2026) was superior to Tween 80. The Factor f2 method was used to show that formulations K and the formulations from example 2 were less than 50 (i.e. not similar). The unexpected results were shown to be statistically significant.
Applicants have not shown unexpected/surprising results for the full scope of claim 6. This leaves Applicants open to future 103s for Markush Search extension, see below.
In regard to the 1st- 4th nonstatutory double patenting rejection, this rejection is withdrawn. Base claim 6 is amended and HAN, DAVE, and SIGMA (for the reasons above) do not teach the amended claim 6.
Response to Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 recites the limitation "the lubricant". There is no previous antecedent for lubricant. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims 8-9, 11-15, 17-19, 29-36, and 40 are similarly rejected for not resolving the rationale under pinning this rejection.
Claim Rejections - 35 USC § 112- New due to Amendments
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15, 17, 18, 35, and 36 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 15, 17, 18, 35, and 36 recite the limitation that the lubricants of claim 6 are optional. However, claim 6 now requires these lubricants. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over NAGI (US8513240B2) as evidenced by SIGMA ALDRICH (“Sodium Dodecyl Sulfate”, Sigma Aldrich, Accessed June 10, 2026) and Kariduraganavar (Kariduraganavar et al., “Polymer Synthesis and Processing”, Natural and Synthetic Biomedical Polymers, 2014) and in view of ZHU (WO 2017101777) and DAVE (Dave, “Overview of pharmaceutical excipients used in tablets and capsules”, October 24, 2008).
NAGI teaches that pharmaceutical composition containing micronized tanaproget, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate (paragraph [0010], and table 3).
Sigma Aldrich is relied upon for the beneficial teaching that Sodium dodecyl sulfate is also known by the name sodium lauryl sulfate (page 1).
Kariduraganavar is relied upon for the beneficial teaching that Polyvinylpyrrolidone (PVP) is commonly called polyvidone or povidone (page 13).
NAGI teaches 90.15 wt% of microcrystalline cellulose (within the range of the instant diluent), 6.00 wt% of croscarmellose sodium (within the range of the instant Disintegrant), 2.0 wt% of Sodium Lauryl Sulfate (one of the instant wetting agents), 1.5 wt% of povidone (within the range of instant binder), and 0.25 wt% of Magnesium Stearate (within the range of the instant lubricant) (table 3).
NAGI teaches abouw 2% wt/wt Sodium Lauryl Sulfate (paragraph [0051]).
NAGI as evidenced by Sigma Aldrich and Kariduraganavar teaches the diluent, binder, wetting agent, disintegrant, and lubricant of base claim 6. This helps teach claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
NAGI also teaches a solid pharmaceutical (“oral dosage unit” and “tablets” in paragraph [0014]). NAGI teaches that compositions of the instant invention provide for a fast drug release (paragraph [0014]).
NAGI does not teach the compound of formula II from the instant claims.
ZHU teaches the compound
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(reference claim 1 and claim 10). This teaches the compound of claim 6.
ZHU also teaches that this compound can be made into a pharmaceutical composition (technical field).
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).
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, lubricant and disintegrant to compound
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(ZHU 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 NAGI’s in order to make a fast release tablet (paragraph [0014]).
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. NAGI teaches a composition (table 3). 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, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
Double Patenting- Due to amendments
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, 9, 12, 13, 14, 15, 30, 32, 34, and 40 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).
NAGI teaches that pharmaceutical composition containing micronized tanaproget, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate (paragraph [0010], and table 3).
Sigma Aldrich is relied upon for the beneficial teaching that Sodium dodecyl sulfate is also known by the name sodium lauryl sulfate (page 1).
Kariduraganavar is relied upon for the beneficial teaching that Polyvinylpyrrolidone (PVP) is commonly called polyvidone or povidone (page 13).
NAGI teaches 90.15 wt% of microcrystalline cellulose (within the range of the instant diluent), 6.00 wt% of croscarmellose sodium (within the range of the instant Disintegrant), 2.0 wt% of Sodium Lauryl Sulfate (one of the instant wetting agents), 1.5 wt% of povidone (within the range of instant binder), and 0.25 wt% of Magnesium Stearate (within the range of the instant lubricant) (table 3).
NAGI teaches abouw 2% wt/wt Sodium Lauryl Sulfate (paragraph [0051]).
NAGI as evidenced by Sigma Aldrich and Kariduraganavar teaches the diluent, binder, wetting agent, disintegrant, and lubricant of base claim 6. This helps teach claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
NAGI also teaches a solid pharmaceutical (“oral dosage unit” and “tablets” in paragraph [0014]). NAGI teaches that compositions of the instant invention provide for a fast drug release (paragraph [0014]).
ZHU teaches the compound
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(reference claim 1 and claim 10). This teaches the compound of claim 6.
ZHU also teaches that this compound can be made into a pharmaceutical composition (technical field).
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).
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 and lubricant to compound
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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 NAGI’s in order to make a fast release tablet (paragraph [0014]).
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. NAGI teaches a composition (table 3). 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, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
Claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40 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.
NAGI teaches that pharmaceutical composition containing micronized tanaproget, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate (paragraph [0010], and table 3).
Sigma Aldrich is relied upon for the beneficial teaching that Sodium dodecyl sulfate is also known by the name sodium lauryl sulfate (page 1).
Kariduraganavar is relied upon for the beneficial teaching that Polyvinylpyrrolidone (PVP) is commonly called polyvidone or povidone (page 13).
NAGI teaches 90.15 wt% of microcrystalline cellulose (within the range of the instant diluent), 6.00 wt% of croscarmellose sodium (within the range of the instant Disintegrant), 2.0 wt% of Sodium Lauryl Sulfate (one of the instant wetting agents), 1.5 wt% of povidone (within the range of instant binder), and 0.25 wt% of Magnesium Stearate (within the range of the instant lubricant) (table 3).
NAGI teaches abouw 2% wt/wt Sodium Lauryl Sulfate (paragraph [0051]).
NAGI as evidenced by Sigma Aldrich and Kariduraganavar teaches the diluent, binder, wetting agent, disintegrant, and lubricant of base claim 6. This helps teach claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
NAGI also teaches a solid pharmaceutical (“oral dosage unit” and “tablets” in paragraph [0014]). NAGI teaches that compositions of the instant invention provide for a fast drug release (paragraph [0014]).
ZHU teaches the compound
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(reference claim 1 and claim 10). This teaches the compound of claim 6.
ZHU also teaches that this compound can be made into a pharmaceutical composition (technical field).
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).
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 and lubricant to compound
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(reference claims). 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 NAGI’s in order to make a fast release tablet (paragraph [0014]).
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. NAGI teaches a composition (table 3). 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, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
Claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40 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).
NAGI teaches that pharmaceutical composition containing micronized tanaproget, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate (paragraph [0010], and table 3).
Sigma Aldrich is relied upon for the beneficial teaching that Sodium dodecyl sulfate is also known by the name sodium lauryl sulfate (page 1).
Kariduraganavar is relied upon for the beneficial teaching that Polyvinylpyrrolidone (PVP) is commonly called polyvidone or povidone (page 13).
NAGI teaches 90.15 wt% of microcrystalline cellulose (within the range of the instant diluent), 6.00 wt% of croscarmellose sodium (within the range of the instant Disintegrant), 2.0 wt% of Sodium Lauryl Sulfate (one of the instant wetting agents), 1.5 wt% of povidone (within the range of instant binder), and 0.25 wt% of Magnesium Stearate (within the range of the instant lubricant) (table 3).
NAGI teaches abouw 2% wt/wt Sodium Lauryl Sulfate (paragraph [0051]).
NAGI as evidenced by Sigma Aldrich and Kariduraganavar teaches the diluent, binder, wetting agent, disintegrant, and lubricant of base claim 6. This helps teach claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
NAGI also teaches a solid pharmaceutical (“oral dosage unit” and “tablets” in paragraph [0014]). NAGI teaches that compositions of the instant invention provide for a fast drug release (paragraph [0014]).
ZHU teaches the compound
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(reference claim 1 and claim 10). This teaches the compound of claim 6.
ZHU also teaches that this compound can be made into a pharmaceutical composition (technical field).
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).
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 and lubricant to compound
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(reference claims). 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 NAGI’s in order to make a fast release tablet (paragraph [0014]).
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. NAGI teaches a composition (table 3). 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, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
Claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40 are rejected on the ground of nonstatutory anticipatory type double patenting as being unpatentable over claims 1, 6 of U.S. application 19/538,573. 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.
Reference Claim 1 teaches a pharmaceutical composition (used in a method) containing the instant compound of formula II.
NAGI teaches that pharmaceutical composition containing micronized tanaproget, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate (paragraph [0010], and table 3).
Sigma Aldrich is relied upon for the beneficial teaching that Sodium dodecyl sulfate is also known by the name sodium lauryl sulfate (page 1).
Kariduraganavar is relied upon for the beneficial teaching that Polyvinylpyrrolidone (PVP) is commonly called polyvidone or povidone (page 13).
NAGI teaches 90.15 wt% of microcrystalline cellulose (within the range of the instant diluent), 6.00 wt% of croscarmellose sodium (within the range of the instant Disintegrant), 2.0 wt% of Sodium Lauryl Sulfate (one of the instant wetting agents), 1.5 wt% of povidone (within the range of instant binder), and 0.25 wt% of Magnesium Stearate (within the range of the instant lubricant) (table 3).
NAGI teaches abouw 2% wt/wt Sodium Lauryl Sulfate (paragraph [0051]).
NAGI as evidenced by Sigma Aldrich and Kariduraganavar teaches the diluent, binder, wetting agent, disintegrant, and lubricant of base claim 6. This helps teach claims 6, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
NAGI also teaches a solid pharmaceutical (“oral dosage unit” and “tablets” in paragraph [0014]). NAGI teaches that compositions of the instant invention provide for a fast drug release (paragraph [0014]).
ZHU teaches the compound
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(reference claim 1 and claim 10). This teaches the compound of claim 6.
ZHU also teaches that this compound can be made into a pharmaceutical composition (technical field).
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).
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 and lubricant to compound
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(reference 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 NAGI’s in order to make a fast release tablet (paragraph [0014]).
The artisan would be motivated to experiment with the weight percentages of each component in the pharmaceutical composition of the instant claims. NAGI teaches a composition (table 3). 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, 9, 12, 13, 14, 15, 30, 32, 34, and 40.
Conclusion
No claims are allowed as written.
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.
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
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