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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 6, 2025 has been entered.
DETAILED ACTION
3. Claims 1 – 2, 4 – 6, 9 – 19, 40, 44, and 50 – 51 are pending in this application. Applicant’s Amendment and Remarks, filed October 6, 2025, is entered, wherein claims 44 and 50 are amended, claims 1 – 2, 4 – 6, 9 – 19, and 40 are withdrawn, and claims 3, 7 – 8, 20 – 39, 41 – 43, and 45 – 49 are canceled.
Claims 44 and 50 – 51 are examined on the merits herein.
Priority
4. This application is a national stage application of PCT/US2019/061171, filed November 13, 2019, which claims benefit of domestic application 62/767,202, filed November 14, 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2025 was filed after the mailing date of the previous Office Action on April 4, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
6. The objection of claims 44 and 50 in the previous Office Action, mailed April 4, 2025, is withdrawn in view of the amended claims 44 and 50.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 44 and 50 – 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2 and 4 – 5 of U.S. Patent No. 12186306B2 (previously cited as copending Application No. 17/546,649).
a. Regarding claims 44 and 50 – 51, ‘306B2 teaches a method of treating cystic fibrosis comprising daily administration of 250 mg of compound I:
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21.24 mg of compound II:
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and 100 mg of compound III:
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(claim 1).
The compounds are administered in a single composition (claim 4). Compounds I, II, and III are also administered as two compositions once daily, each composition comprising 125mg of compound I, 10.62 mg of compound II, and 50 mg of compound III (claim 5).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of compound II as taught by ‘306B2 because ‘306B2 teaches the reduced amount of compound II from 21.24 to 10.62 mg. One would have performed a routine experimentation to discover the best dosage of compound II for optimal treatment characteristics. One would also have been motivated to seek the lowest effective dosage. Furthermore, it would have expected that a skilled artisan will formulate the claimed pharmaceutical composition with a pharmaceutically acceptable carrier to achieve the desired route of administration. Therefore, one of the skills in the art would have had a reasonable expectation of success as ‘306B2 teaches the reduced amount of the components are still effective for the same purpose.
Claims 44 and 50 – 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40 – 41 and 46 – 47 of U.S. Patent No. 11066417B2 in view of Miller et al. (US9782408B2).
b. Regarding claims 44 and 50 – 51, ‘417B2 teaches a compound of the formula (claims 40 – 41):
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or a pharmaceutically acceptable salt thereof. ‘417B2 also teaches a pharmaceutical composition comprising the compound in combination with Compound II and/or Compound III (claims 46 – 47):
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and
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and a pharmaceutically acceptable carrier.
However, ‘417B2 does not teach the composition comprising 5 mg of Compound I.
Miller et al. teaches a compound of formula I:
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for the treatment of cystic fibrosis (Abstract). Miller et al. specifically teaches a few compounds as shown below (Col. 403 – 404; Col. 405 – 406; Col. 623 – 624):
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Miller et al. also teaches that the pharmaceutical compositions of the invention are administered as oral formulations containing about 25 mg of a compound of Formula I (Col. 2138, lines 66 – 67). Moreover, Miller et al. teaches that a compound of Formula I can be used with other therapeutic agents (claim 81):
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Miller et al. teaches that Compound II and III are CFTR modulators (Col. 2150, lines 20 – 50; Col. 2151, lines 40 – 65).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pharmaceutical composition as taught by ‘417B2 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘417B2 in view of Miller et al. because ‘417B2 teaches the pharmaceutical composition comprising compound 195 and two CFTR modulating agents (compound II and III) and Miller et al. teaches the pharmaceutical composition comprising compounds 15, 17, or 384, and other CFTR modulating agents. Based on the additional CFTR modulating agents, one would have been motivated to consider the specific dosage of compounds 15, 17, or 384 disclosed by Miller et al. because both compositions disclosed by ‘417B2 and Miller et al. are targeting to treat the same disease, thereby, yielding predictable results. One would have been performed a routine experimentation to discover the best dosage of the claim compound for the optimal treatment characteristics based on the disclosure of Miller et al. Therefore, one of the skills in the art would have a reasonable expectation of success combine the pharmaceutical composition as taught by ‘417B2 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘417B2 in view of Miller et al. as ‘417B2 teaches the exact compound and Miller et al. teaches compounds with the same core structure and the amount used for the same purpose.
Claims 44 and 50 – 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 37, and 40 – 41 of U.S. Patent No. 11866450B2 in view of Miller et al. (US9782408B2).
c. Regarding claims 44 and 50 – 51, ‘450B2 teaches a method of treating cystic fibrosis comprising administering to a patient in need a compound of Formula I (claim 1):
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‘450 further teaches a method of treating cystic fibrosis comprising administering to a patient in need thereof a compound of (claim 37):
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or a pharmaceutically acceptable salt thereof. Compound 195 is administered in combination with one or more of compound II and compound III or compound III-d (claims 40 – 41):
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However, ‘450B2 does not teach the composition comprising 5 mg of Compound I.
Miller et al. teaches a compound of formula I:
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for the treatment of cystic fibrosis (Abstract). Miller et al. specifically teaches a few compounds as shown below (Col. 403 – 404; Col. 405 – 406; Col. 623 – 624):
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Miller et al. also teaches that the pharmaceutical compositions of the invention are administered as oral formulations containing about 25 mg of a compound of Formula I (Col. 2138, lines 66 – 67). Moreover, Miller et al. teaches that a compound of Formula I can be used with other therapeutic agents (claim 81):
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Miller et al. teaches that Compound II and III are CFTR modulators (Col. 2150, lines 20 – 50; Col. 2151, lines 40 – 65).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pharmaceutical composition as taught by ‘450B2 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘450B2 in view of Miller et al. because ‘450B2 teaches the pharmaceutical composition comprising compound 195 and two CFTR modulating agents (compound II and III) and Miller et al. teaches the pharmaceutical composition comprising compounds 15, 17, or 384, and other CFTR modulating agents. Based on the additional CFTR modulating agents, one would have been motivated to consider the specific dosage of compounds 15, 17, or 384 disclosed by Miller et al. because both compositions disclosed by ‘450B2 and Miller et al. are targeting to treat the same disease, thereby, yielding predictable results. One would have been performed a routine experimentation to discover the best dosage of the claim compound for the optimal treatment characteristics based on the disclosure of Miller et al. Furthermore, it would have expected that a skilled artisan will formulate the claimed pharmaceutical composition with a pharmaceutically acceptable carrier to achieve the desired route of administration. Therefore, one of the skills in the art would have a reasonable expectation of success combine the pharmaceutical composition as taught by ‘450B2 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘450B2 in view of Miller et al. as ‘450B2 teaches the exact compound and Miller et al. teaches compounds with the same core structure and the amount used for the same purpose.
Claims 44 and 50 – 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3 and 6 – 9 of U.S. Patent No. 11873300B2 in view of Miller et al. (US9782408B2).
d. Regarding claims 44 and 50 – 51, ‘300B2 teaches a pharmaceutical composition comprising Compound I calcium salt hydrate Form D (claims 1 – 2):
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‘300B2 further teaches that the pharmaceutical composition further comprising one or more additional CFTR modulating compounds (claim 3), wherein the CFTR modulating compounds are
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(claim 6).
Finally, ‘300B2 teaches that the pharmaceutical composition is for treating cystic fibrosis (claims 7 – 9).
However, ‘300B2 does not teach the composition comprising 5 mg of Compound I.
Miller et al. teaches a compound of formula I:
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for the treatment of cystic fibrosis (Abstract). Miller et al. specifically teaches a few compounds as shown below (Col. 403 – 404; Col. 405 – 406; Col. 623 – 624):
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Miller et al. also teaches that the pharmaceutical compositions of the invention are administered as oral formulations containing about 25 mg of a compound of Formula I (Col. 2138, lines 66 – 67). Moreover, Miller et al. teaches that a compound of Formula I can be used with other therapeutic agents (claim 81):
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Miller et al. teaches that Compound II and III are CFTR modulators (Col. 2150, lines 20 – 50; Col. 2151, lines 40 – 65).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pharmaceutical composition as taught by ‘300B2 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘300B2 in view of Miller et al. because ‘300B2 teaches the pharmaceutical composition comprising compound I and two CFTR modulating agents (compound II and III) and Miller et al. teaches the pharmaceutical composition comprising compounds 15, 17, or 384, and other CFTR modulating agents. Based on the additional CFTR modulating agents, one would have been motivated to consider the specific dosage of compounds 15, 17, or 384 disclosed by Miller et al. because both compositions disclosed by ‘300B2 and Miller et al. are targeting to treat the same disease, thereby, yielding predictable results. One would have been performed a routine experimentation to discover the best dosage of the claim compound for the optimal treatment characteristics based on the disclosure of Miller et al. Furthermore, it would have expected that a skilled artisan will formulate the claimed pharmaceutical composition with a pharmaceutically acceptable carrier to achieve the desired route of administration. Therefore, one of the skills in the art would have a reasonable expectation of success combine the pharmaceutical composition as taught by ‘300B2 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘300B2 in view of Miller et al. as ‘300B2 teaches the exact compound and Miller et al. teaches compounds with the same core structure and the amount used for the same purpose.
Claims 44 and 50 – 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 of copending Application No. 18/020,802 in view of Miller et al. (US9782408B2).
e. Regarding claims 44 and 50 – 51, ‘802 teaches a crystalline Compound I (claim 1):
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‘802 teaches a pharmaceutical composition comprising the crystalline Compound I and further comprising one or more additional CFTR modulating compounds (claims 7 – 8). ‘802 teaches a method of treating cystic fibrosis comprising administering the crystalline Compound I with one or more additional CFTR modulating compounds (claims 15 – 16). ‘802 further teaches a method of preparing this crystalline Compound I (claim 21).
However, ‘802 does not teach the composition comprising 5 mg of Compound I, and ‘802 does not teach the specific CFTR modulating compounds.
Miller et al. teaches a compound of formula I:
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for the treatment of cystic fibrosis (Abstract). Miller et al. specifically teaches a few compounds as shown below (Col. 403 – 404; Col. 405 – 406; Col. 623 – 624):
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Miller et al. also teaches that the pharmaceutical compositions of the invention are administered as oral formulations containing about 25 mg of a compound of Formula I (Col. 2138, lines 66 – 67). Moreover, Miller et al. teaches that a compound of Formula I can be used with other therapeutic agents (claim 81):
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Miller et al. teaches that Compound II and III are CFTR modulators (Col. 2150, lines 20 – 50; Col. 2151, lines 40 – 65).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pharmaceutical composition as taught by ‘802 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘802 and the specific CFTR modulators in view of Miller et al. because ‘802 teaches the pharmaceutical composition comprising compound I and two CFTR modulating agents and Miller et al. teaches the pharmaceutical composition comprising compounds 15, 17, or 384, and other CFTR modulating agents. Based on the additional CFTR modulating agents, one would have been motivated to consider the specific dosage of compounds 15, 17, or 384 disclosed by Miller et al. because both compositions disclosed by ‘802 and Miller et al. are targeting to treat the same disease, thereby, yielding predictable results. One would have been performed a routine experimentation to discover the best dosage of the claim compound for the optimal treatment characteristics based on the disclosure of Miller et al. Furthermore, it would have expected that a skilled artisan will formulate the claimed pharmaceutical composition with a pharmaceutically acceptable carrier to achieve the desired route of administration. Therefore, one of the skills in the art would have a reasonable expectation of success combine the pharmaceutical composition as taught by ‘802 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘802 and the specific CFTR modulators in view of Miller et al. as ‘802 teaches the exact compound and Miller et al. teaches compounds with the same core structure as well as the specific examples of CFTR modulators and the amount used for the same purpose.
This is a provisional nonstatutory double patenting rejection.
Claims 44 and 50 – 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 9 and 21 – 26 of copending Application No. 18/835,221 in view of Miller et al. (US9782408B2).
f. Regarding claims 44 and 50 – 51, ‘221 teaches a method of treating cystic fibrosis comprising administering to a patient in need thereof 0.1 mg to about 50 mg of Compound I: crystalline Compound I (claims 1 – 9):
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‘221 teaches that the method further comprises administering one or more additional therapeutic agents with CFTR-modulating activity (claims 21 – 23). The one or more additional therapeutic agents are (claims 24 – 26)
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However, ‘221 does not teach the composition comprising 5 mg of Compound I.
Miller et al. teaches a compound of formula I:
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for the treatment of cystic fibrosis (Abstract). Miller et al. specifically teaches a few compounds as shown below (Col. 403 – 404; Col. 405 – 406; Col. 623 – 624):
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Miller et al. also teaches that the pharmaceutical compositions of the invention are administered as oral formulations containing about 25 mg of a compound of Formula I (Col. 2138, lines 66 – 67). Moreover, Miller et al. teaches that a compound of Formula I can be used with other therapeutic agents (claim 81):
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Miller et al. teaches that Compound II and III are CFTR modulators (Col. 2150, lines 20 – 50; Col. 2151, lines 40 – 65).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pharmaceutical composition as taught by ‘221 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘221 in view of Miller et al. because ‘221 teaches the pharmaceutical composition comprising compound I and one or more additional CFTR modulating agents and Miller et al. teaches the pharmaceutical composition comprising compounds 15, 17, or 384, and other CFTR modulating agents. Based on the additional CFTR modulating agents, one would have been motivated to consider the specific dosage of compounds 15, 17, or 384 disclosed by Miller et al. because both compositions disclosed by ‘221 and Miller et al. are targeting to treat the same disease, thereby, yielding predictable results. One would have been performed a routine experimentation to discover the best dosage of the claim compound for the optimal treatment characteristics based on the disclosure of Miller et al. Furthermore, it would have expected that a skilled artisan will formulate the claimed pharmaceutical composition with a pharmaceutically acceptable carrier to achieve the desired route of administration. Therefore, one of the skills in the art would have a reasonable expectation of success combine the pharmaceutical composition as taught by ‘221 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘221 in view of Miller et al. as ‘221 teaches the exact compounds and Miller et al. teaches compounds with the same core structure and the amount used for the same purpose.
This is a provisional nonstatutory double patenting rejection.
Claims 44 and 50 – 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 – 10, 13 – 16, and 18 of copending Application No. 19/185,978 in view of Miller et al. (US9782408B2).
g. Regarding claims 44 and 50 – 51, ‘978 teaches a pharmaceutical composition comprising Compound I (free form) Form A (claims 1 and 9):
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The composition further comprises one or more additional CFTR modulating compounds (claim 10), wherein the one or more additional CFTR modulating compounds are
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(claim 13).
‘978 also teach a method of treating cystic fibrosis comprising administering Compound I to a subject in need thereof (claim 14), wherein Compound I is administered along with one or more additional CFTR modulating compounds (claim 15), wherein the CFTR modulating compounds are:
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(claim 16).
However, ‘978 does not teach the composition comprising 5 mg of Compound I (free form) Form A.
Miller et al. teaches a compound of formula I:
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for the treatment of cystic fibrosis (Abstract). Miller et al. specifically teaches a few compounds as shown below (Col. 403 – 404; Col. 405 – 406; Col. 623 – 624):
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Miller et al. also teaches that the pharmaceutical compositions of the invention are administered as oral formulations containing about 25 mg of a compound of Formula I (Col. 2138, lines 66 – 67). Moreover, Miller et al. teaches that a compound of Formula I can be used with other therapeutic agents (claim 81):
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Miller et al. teaches that Compound II and III are CFTR modulators (Col. 2150, lines 20 – 50; Col. 2151, lines 40 – 65).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pharmaceutical composition as taught by ‘978 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘978 in view of Miller et al. because ‘978 teaches the pharmaceutical composition comprising compound I and one or more additional CFTR modulating agents and Miller et al. teaches the pharmaceutical composition comprising compounds 15, 17, or 384, and other CFTR modulating agents. Based on the additional CFTR modulating agents, one would have been motivated to consider the specific dosage of compounds 15, 17, or 384 disclosed by Miller et al. because both compositions disclosed by ‘978 and Miller et al. are targeting to treat the same disease, thereby, yielding predictable results. One would have been performed a routine experimentation to discover the best dosage of the claim compound for the optimal treatment characteristics based on the disclosure of Miller et al. Furthermore, it would have expected that a skilled artisan will formulate the claimed pharmaceutical composition with a pharmaceutically acceptable carrier to achieve the desired route of administration. Therefore, one of the skills in the art would have a reasonable expectation of success combine the pharmaceutical composition as taught by ‘978 with the therapeutic amount of the compounds with the same core structure as disclosed in ‘978 in view of Miller et al. as ‘978 teaches the exact compounds and Miller et al. teaches compounds with the same core structure and the amount used for the same purpose.
This is a provisional nonstatutory double patenting rejection.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed October 6, 2025, have been fully considered and are found to be not persuasive.
Regarding ‘306, Applicant argues that it is a later-filed, later-expiring patent. Therefore, it is not a proper reference for an obviousness-type double patenting rejection. However, the rejection is consistent with established practice for addressing nonstatutory double patenting. As explained in MPEP 804(II)(B)(5), a later-expiring patent may serve as a proper reference in a one-way obviousness-type double patenting rejection unless the applicant can show that the claims could not have been filed in a single application and that the Office was solely responsible for any delay that caused the reference patent to issue first. In the present case, Applicant does not provide evidence that the Office, rather than Applicant, is solely responsible for any prosecution delay, nor that the claims could not have been presented together. Courts have consistently held that applicant-driven prosecution choices, such as filing multiple applications or continuations, do not warrant application of the two-way test. Therefore, the one-way test applies, and the double patenting rejection over ‘306 remains proper.
Applicant further argues that claim 5 simply recited administering a total dose of 21.24 mg divided over two tablets, and does not teach the treatment of cystic fibrosis by administering only 10.62 mg of Compound II calcium salt hydrate Form D. Claim 5 of ‘306 recites “wherein the Compound II calcium salt hydrate Form D is administered as two compositions once daily, each comprising 10.62 m of Compound II calcium salt hydrate Form D, whereas claim 44 of the present application recites a pharmaceutical composition comprising about 5 mg of Compound I. Claim 44 is not directed to the total dosage to treat cystic fibrosis, but only directed to the pharmaceutical composition comprising 5 mg of Compound I. Therefore, Applicant’s argument regarding the total dosage is not persuasive and the NSDP rejection is maintained.
Regarding Miller et al., Applicant argues that a POSA would not have looked at Miller et al., simply because Miller et al do not teach compounds with a macrocyclic core structure. Therefore, the range of dosages for the compounds of Miller et al. cannot serve as a starting point to determine the particular about 5 mg claimed dosage of Compound I. Pharmaceutical compounds are an unpredictable art and it cannot be inferred that the dosages of such different compounds would be similar or provide a starting point. Applicant also believes that the lowest dose taught by Miller et al. is still five-fold higher than the claimed amount. However, the examiner would like to point to the fact that the exemplary compounds listed in the rejection all contain the core structure of:
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and are used to treat cystic fibrosis. According to Zou et al. (The AAPS Journal, 2012, Vol. 14, Issue 2, page 262 – 281, Reference included with PTO-892), similar drug comparison approach may be used when human PK/PD data are available for a drug similar to the one under investigation. The dose of the investigated drug can be calculated from the dose of the reference drug. The dose obtained is usually corrected by an arbitrary safety factor to accommodate uncertainty (page 263, Right Col., para. 2). Therefore, it is a common practice to use similar drug as a starting point for obtaining the dosage for the investigated drug. Further, optimization of dosage is considered within the routine skill in the art. The mere fact that Miller et al. disclose a higher dose does not teach away from lower doses. The discovery of optimal ranges is not patentable absent evidence of criticality of unexpected results, neither of which has been provided.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693