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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 22 July 2026 is acknowledged.
Group II claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 July 2026.
Claims 68-97 are under current consideration.
Claim Objections
Claim 75 is objected to because of the following informalities: the terms “20 uM” and “180 uM” should be corrected to “20 µm” and “180 µm”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 89 and 91-92 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.
Claim 89 fails to include all the limitations of claim 85 upon which it depends in that claim 89 recites intragranular MgSt content down to about 0.5 wt.% but claim 85 requires intragranular MgSt content of at least 1 wt%.
Claim 91 fails to include all the limitations of claim 85 upon which it depends in that claim 91 recites intragranular CCS content of about 2-4 wt.% but claim 85 requires intragranular CCS content of about 2.5-3.5 wt%. Claim 92 is rejected as depending upon claim 91 without remedying such deficiency.
Claim 92 fails to include all the limitations of claim 85 upon which it depends in that claim 92 recites extragranular MgSt content down to about 0.75 wt.% but claim 85 requires extragranular MgSt content of at least about 1 wt%.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 68-74 and 76-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor et al. (WO 2024/211271 A1; published 10 October 2024; priority to 03 April 2023) in view of Merchant et al. (US 2023/0321102 A1; published 12 October 2023; priority to 06 April 2022) and Kothari et al. (US 2022/0339111 A1; published 27 October 2022).
Connor et al. discloses a pharmaceutical composition formulated for immediate release as a film coated tablet for oral administration comprising pharmaceutically acceptable excipients (paragraph [0063]) wherein the composition comprises a KRAS inhibitor therapeutic agent such as GDC-6036 (i.e., divarasib) (paragraph [0186]) wherein the composition comprises about 1-10% w/w disintegrant, about 70-90% w/w diluent, and about 0.1-2% w/w lubricant (claim 1) wherein disintegrant is croscarmellose sodium (i.e., CCS) (claim 7) wherein diluent is microcrystalline cellulose (i.e., MCC) (claim 4) wherein lubricant is magnesium stearate (i.e., MgSt) (claim 13) wherein the composition treats cancer (claim 21).
Connor et al. does not disclose the divarasib as adipate salt, or that the microcrystalline cellulose filler is about 15-50 wt%, as in claim 68.
Merchant et al. discloses treatment of cancer using GDC-6036 (i.e., divarasib) (title) wherein the GDC-6036 is an adipate salt (paragraph [0025]) administered orally as a tablet (claim 5)
Kothari et al. discloses immediate-release tablets (title) such as for cancer medicaments (paragraph [0117]) wherein a tablet core comprises about 5 wt% or more of a particulate pharmaceutical active drug, about 0.5-5 wt% lubricant, about 2-7 wt% disintegrant, and about 60-78 wt% filler (claim 23) wherein filler, disintegrant, and lubricant are intragranular components, and disintegrant and lubricant are extragranular components (paragraph [0036]) and filler is an extragranular component (paragraphs [0082]-[0083]) wherein the tablet core comprises about 0.25-5 wt% intragranular lubricant and about 0.5-2.5 wt% extragranular lubricant (claim 27) wherein the tablet core comprises about 0.1-3 wt% intragranular disintegrant and about 0.5-3 wt% extragranular disintegrant (claim 29) wherein lubricant is magnesium stearate, disintegrant is croscarmellose sodium, and filler is microcrystalline cellulose (claim 45) wherein a tablet core may contain 45.6% w/w intragranular microcrystalline cellulose filler, 2% w/w intragranular croscarmellose sodium disintegrant, 0.25% w/w intragranular magnesium stearate lubricant, 2% w/w extragranular croscarmellose sodium disintegrant, and 1.25% w/w extragranular magnesium stearate lubricant (Example 3, paragraph [0155]) wherein the tablets have acceptable tensile strength of ≥ 2 MPa (paragraph [0141]) wherein ribbon solid fraction (RSF, relative density) is 0.78 (paragraph [0144] Table 2.1) wherein the tablets have disintegration time Y8 of 83-210 s (paragraphs [0144]-[0145] Table 2.1, [0147] Table 2.4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Connor et al., Merchant et al., and Kothari et al. by making the oral film coated tablet of Connor et al. with divarasib therapeutic agent, about 1-10% w/w CCS disintegrant, diluent MCC, and about 0.1-2% w/w MgSt lubricant, for treating cancer, as discussed above, wherein the divarasib is divarasib adipate as suggested by Merchant et al., and wherein the MCC diluent/filler is in a concentration of 45.6 wt% as suggested by Kothari et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use therein a form of divarasib known to be suitable for use in oral tablets for treating cancer as suggested by Merchant et al., given that both Connor et al. and Merchant et al. are directed to use of oral tablets comprising divarasib for treating cancer, and given that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination per MPEP 2144.07. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been further motivated to do so to use therein an amount/concentration of MCC diluent/filler known to be suitable for use as diluent/filler in oral tablets for treating cancer as suggested by Kothari et al., given that Connor et al., Merchant et al., and Kothari et al. are all directed to use of oral tablets for treating cancer, and given that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination per MPEP 2144.07, and also given that a range can be disclosed in multiple prior art references per MPEP 2144.05(I) such as a range of tablet core concentration of MCC of 45.6 wt% as suggested by Kothari et al. to about 78 wt% as suggested by Connor et al.
Regarding the claimed CCS disintegrant concentration range of about 2-13 wt% in claim 68, such range of about 1-10% w/w CCS disintegrant disclosed by Connor et al. overlaps the claimed range, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding claims 69-70, although Connor et al., Merchant et al., and Kothari et al. do not disclose such concentrations of divarasib adipate, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize cancer treatment and active agent effectiveness of the divarasib adipate in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above by varying the concentration of divarasib adipate active agent in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that divarasib adipate was a known active agent for treating cancer and thus a known result effective variable, and also given that drug concentration is a result-effective variable that is a matter of routine optimization. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Regarding the claimed CCS disintegrant concentration range of about 5-10 wt% in claim 72, such range of about 1-10% w/w CCS disintegrant disclosed by Connor et al. overlaps the claimed range, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding the claimed CCS disintegrant concentration range of about 7-8 wt% in claim 73, such range of about 1-10% w/w CCS disintegrant disclosed by Connor et al. overlaps the claimed range, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding the claimed MCC disintegrant concentration range of about 20 to about 45 wt% in claim 76, such concentration of 45.6 wt% MCC diluent/filler in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range in that 45.6 wt% is about 45 wt%, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I). Alternatively, such concentration of 45.6 wt% MCC diluent/filler in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above is so close to the claimed range of about 20 to about 45 wt% that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”).
Regarding the claimed MCC disintegrant concentration range of about 30 to about 40 wt% in claim 77, such concentration of 45.6 wt% MCC diluent/filler in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above is so close to the claimed range of about 30 to about 40 wt% that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”).
Regarding the claimed MgSt lubricant concentration range of about 1-3 wt% in claim 78, such concentration of about 0.1-2% w/w MgSt lubricant in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding claim 79, such concentration of about 1-10% w/w CCS disintegrant in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 4-11 wt% CCS, and such concentration of about 0.1-2% w/w MgSt lubricant in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 1.5-2.5 wt% MgSt, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I). Regarding the claimed MCC disintegrant concentration range of about 20 to about 40 wt% in claim 79, such concentration of 45.6 wt% MCC diluent/filler in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above is so close to the claimed range of about 20 to about 40 wt% that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”).
Regarding claim 80, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Connor et al., Merchant et al., and Kothari et al. as discussed above and to make the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above wherein the tablets have tensile strength of ≥ 2 MPa and ribbon solid fraction (RSF, relative density) of 0.78 as suggested by Kothari et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make tablets that have acceptable tensile strength and solid fraction for oral tablets as suggested by Kothari et al. Such tensile strength range of ≥ 2 MPa overlaps the claimed range of about 2-3 MPa, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I). Such solid fraction of 0.78 lies within the claimed range of about 0.8-0.9, or alternatively is so close to the claimed range that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”).
Regarding claims 82-84, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Connor et al., Merchant et al., and Kothari et al. as discussed above and to make the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above wherein the tablets have disintegration time of 83-210 s as suggested by Kothari et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make tablets that have acceptable disintegration time for oral tablets as suggested by Kothari et al. Such range of 83-210 s lies within the claimed ranges of about 15 minutes or less, about 10 minutes or less, and about 5 minutes or less.
Regarding claim 85, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Connor et al., Merchant et al., and Kothari et al. as discussed above and to make the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above wherein the divarasib adipate therapeutic agent therein is intragranular, the CCS disintegrant therein is about 0.1-3 wt% intragranular CCS disintegrant and about 0.5-3 wt% extragranular CCS disintegrant, the MCC diluent/filler therein is 45.6 wt% intragranular MCC diluent/filler and remainder of total diluent/filler of about 60-78 wt% diluent/filler is thus extragranular resulting in about 60 to 78 wt% minus 45.6 wt% or about 14.4-32.4 extragranular MCC diluent/filler, and the MgSt lubricant therein is about 0.25-5 wt% intragranular MgSt lubricant and about 0.5-2.5 wt% extragranular MgSt lubricant, as suggested by Kothari et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make tablets that have acceptable intragranular/extragranular structure for oral tablets as suggested by Kothari et al.
Such ranges of about 0.1-3 wt% intragranular CCS disintegrant, about 0.5-3 wt% extragranular CCS disintegrant, about 14.4-32.4 wt% extragranular MCC diluent/filler, about 0.25-5 wt% intragranular MgSt lubricant, and about 0.5-2.5 wt% extragranular MgSt lubricant, overlap the claimed ranges of about 2.5-3.5 wt% intragranular CCS disintegrant, about 3-6 wt% extragranular CCS disintegrant, about 10-20 wt% extragranular MCC diluent/filler, 1-3 wt% intragranular MgSt lubricant, and about 1-2 wt% extragranular MgSt lubricant, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding the 45.6 wt% intragranular MCC diluent/filler, such amount is so close to the claimed range of about 10 to about 30 wt% intragranular MCC diluent/filler that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”). Alternatively, it would have been prima facie obvious to optimize filling/dilution within the granules of the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above to achieve suitable granules for use in the tablets by varying the amount/concentration of MCC filler/diluent therein through routine experimentation per MPEP 2144.05(II), given that MCC was a known filler/diluent in oral tablet granules and thus was a result-effective variable.
Regarding claim 86, such claimed extragranular disintegrant concentration range of about 4-5 wt% overlaps the range of about 0.5-3 wt% extragranular CCS disintegrant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I). Alternatively, such range of about 0.5-3 wt% extragranular CCS disintegrant is so close to the claimed range of about 4-5 wt% extragranular CCS disintegrant that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”).
Regarding claim 87, the 45.6 wt% intragranular MCC diluent/filler in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above is so close to the claimed range of about 15 to about 25 wt% intragranular MCC diluent/filler that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”). Alternatively, it would have been prima facie obvious to optimize filling/dilution within the granules of the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above to achieve suitable granules for use in the tablets by varying the amount/concentration of MCC filler/diluent therein through routine experimentation per MPEP 2144.05(II), given that MCC was a known filler/diluent in oral tablet granules and thus was a result-effective variable.
Regarding claim 88, the about 14.4-32.4 wt% extragranular MCC diluent/filler in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 14-16 wt% extragranular MCC diluent/filler, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding claim 89, the about 0.25-5 wt% intragranular MgSt lubricant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 0.5-1.25 wt% intragranular MgSt lubricant, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding claim 90, the about 0.5-2.5 wt% extragranular MgSt lubricant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 1-1.75 wt% extragranular MgSt lubricant, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding claim 91, the about 0.1-3 wt% intragranular CCS disintegrant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 2-4 wt% intragranular CCS disintegrant, the about 0.25-5 wt% intragranular MgSt lubricant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 2-1.25 wt% intragranular MgSt lubricant, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I). Regarding the 45.6 wt% intragranular MCC diluent/filler in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above, such range is so close to the claimed range of about 17 to about 23 wt% intragranular MCC diluent/filler that a prima facie case of obviousness exists per MPEP 2144.05(I)(“a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”; “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”). Alternatively, it would have been prima facie obvious to optimize filling/dilution within the granules of the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above to achieve suitable granules for use in the tablets by varying the amount/concentration of MCC filler/diluent therein through routine experimentation per MPEP 2144.05(II), given that MCC was a known filler/diluent in oral tablet granules and thus was a result-effective variable.
Regarding claim 92, the about 14.4-32.4 wt% extragranular MCC diluent/filler in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 11-19 wt% extragranular MCC diluent/filler, the about 0.5-3 wt% extragranular CCS disintegrant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 3-6 wt% extragranular CCS disintegrant, the about 0.5-2.5 wt% extragranular MgSt lubricant in the tablets of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above overlaps the claimed range of about 0.75-2 wt% extragranular MgSt lubricant, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Regarding claims 93 and 95-97, see above regarding claims 80 and 82-84.
Claim(s) 68-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor et al. in view of Merchant et al. and Kothari et al. as applied to claims 68-74 and 76-97 above, and further in view of Sherwood et al. (US 2009/0169621 A1; published 02 July 2009).
Connor et al., Merchant et al., and Kothari et al. are relied upon as discussed above.
Connor et al., Merchant et al., and Kothari et al. do not disclose MCC having an average particle size of about 20-180 µm as in claim 75.
Sherwood et al. discloses a microcrystalline cellulose based excipient having improved compressibility (abstract) wherein microcrystalline cellulose is a well-known tablet diluent that is commercially available with average particle size from 20 to 200 microns (paragraph [0052]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Connor et al., Merchant et al., Kothari et al., and Sherwood et al. by using microcrystalline cellulose with average particle size from 20 to 200 microns as suggested by Sherwood et al. as the microcrystalline cellulose in the tablet of Connor et al. in view of Merchant et al. and Kothari et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a microcrystalline cellulose therein that is commercially available and known for use as a tablet diluent as suggested by Sherwood et al.
Such average particle size range of 20-200 microns overlaps the claimed range of about 20-180 µm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap prima facie obvious per MPEP 2144.05(I).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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