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 . Claims included in prosecution are claims 76-83.
Restriction Requirement
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 76-83, drawn to a pharmaceutical composition, classified in A61K 9/5084.
II. Claims 84-99, drawn to a method of treating dementia related psychosis, classified in A61P 25/18.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the composition can be used to treat diseases such as schizophrenia.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Yahua Chen on 12/17/25 a provisional election was made without traverse to prosecute the invention of Group I, claims 76-83. Affirmation of this election must be made by applicant in replying to this Office action. Claims 84-99 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claim(s) 76-79 and 83 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
Elenko discloses a method of using a combination of one or more muscarinic agonists and one or more muscarinic antagonists for treatment of diseases that are ameliorated by activation of muscarinic receptors ( e.g., schizophrenia and related disorders); as well as a medicament comprising one or more muscarinic agonists and one or more muscarinic antagonists (col 1, line 24-30). Elenko specifically claims a single oral capsule comprising xanomeline and/or a salt thereof in an amount to cause a side effect chosen from nausea, vomiting, diarrhea, sweating and excess salivation; and trospium chloride in an amount effective to reduce the side effect associated with the oral administration of the xanomeline and/or the salt thereof (Ref. Claim 1). The formulation contains from 1 milligram to 1 gram of xanomeline and/or the salt thereof (Ref. Claim 5). The formulation contains from 1 milligram to 400 milligrams of trospium chloride (Ref. Claim 9). The salt of xanomeline is the salt of tartaric acid (Ref. Claim 15).
Regarding the in vivo plasma profiles recited in instant claim 78, the composition of Elenko comprises substantially the same actives where it comprises xanomeline and trospium chloride in individual amounts that satisfy with the amounts instantly claimed. Accordingly, when used in amounts such as the ones disclosed by Elenko, the xanomeline and trospium chloride claimed by Elenko would inherently result in an in vivo plasma profile such as the one instantly claimed.
Regarding claim 79 reciting a first component and a second component, as discussed above, Elenko discloses a capsule comprising xanomeline and trospium chloride. This would satisfy a first and second component as instantly claimed.
The prior art anticipates the instant claims because it specifically claims a capsule comprising xanomeline tartrate and trospium chloride in amounts as instantly claimed and ratios as instantly claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claim(s) 76-79 and 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
Elenko discloses a method of using a combination of one or more muscarinic agonists and one or more muscarinic antagonists for treatment of diseases that are ameliorated by activation of muscarinic receptors ( e.g., schizophrenia and related disorders); as well as a medicament comprising one or more muscarinic agonists and one or more muscarinic antagonists (col 1, line 24-30). Elenko specifically claims a single oral capsule comprising xanomeline and/or a salt thereof in an amount to cause a side effect chosen from nausea, vomiting, diarrhea, sweating and excess salivation; and trospium chloride in an amount effective to reduce the side effect associated with the oral administration of the xanomeline and/or the salt thereof (Ref. Claim 1). The formulation contains from 1 milligram to 1 gram of xanomeline and/or the salt thereof (Ref. Claim 5). The formulation contains from 1 milligram to 400 milligrams of trospium chloride (Ref. Claim 9). The salt of xanomeline is the salt of tartaric acid (Ref. Claim 15).
It is believed that Elenko anticipates the instant claims. However, purely arguendo and for the purposes of this rejection, Elenko differs from the instant claims insofar as not explicitly disclosing wherein the xanomeline is included in amount ranging from 20 mg to 66.7 mg and the trospium chloride is included in an amount ranging from 2 mg to 6.67 mg.
However, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Elenko’s composition comprises xanomeline in an amount of 1 mg to 1 g and trospium chloride in an amount of 1 mg to 400 mg. Accordingly, because the amounts recited in the instant claims lie inside the ranges disclosed by Elenko, the ranges disclosed by Elenko meet the instantly recited limitations.
Regarding the ratio of xanomeline to trospium chloride recited in instant claim 76 (i.e., 10:1), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Elenko’s composition comprises xanomeline in an amount of 1 mg to 1 g and trospium chloride in an amount of 1 mg to 400 mg. Accordingly, the claimed ratio would have been obvious from one of ordinary skill in the art selecting an amount of xanomeline and an amount of trospium chloride from the above ranges and such ratio overlapping with the claimed ratio.
Regarding the amounts of xanomeline and trospium chloride recited in instant claims 77, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Elenko’s composition comprises xanomeline in an amount of 1 mg to 1 g and trospium chloride in an amount of 1 mg to 400 mg. Accordingly, because the amounts recited in the instant claims lie inside the ranges disclosed by Elenko, the ranges disclosed by Elenko meet the instantly recited limitations.
Regarding the in vivo plasma profiles recited in instant claim 78, the composition of Elenko comprises substantially the same actives where it comprises xanomeline and trospium chloride in individual amounts that overlap with the amounts instantly claimed. Accordingly, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Elenko would result in an in vivo plasma profile such as the one instantly claimed.
Regarding claim 79 reciting a first component and a second component, as discussed above, Elenko discloses a capsule comprising xanomeline and trospium chloride. This would satisfy a first and second component as instantly claimed.
2. Claim(s) 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko) in view of Sidwell et al. (Formulation: Developing Oral Controlled-Release Drug Products, Jul. 18, 2019) (hereinafter Sidwell).
The teachings of Elenko are discussed above.
The teachings of Elenko differ from the instant claim insofar as not disclosing wherein the actives are in the form of beads.
However, Sidwell discloses that small beads containing the API are placed in capsules where the beads can be prepared by various methods (Pg. 4). In contrast to tablets, capsules which contain beads can separate populations of beads (i.e., multiple pluralities of beads) to keep multiple APIs separate and to have them release at different times, achieving complex release patterns. Furthermore, because capsules package APIs as beads that behave independently, the dose or component release profile can be easily adjusted without affecting other product attributes. Finally, unlike tablets, capsule beads move gradually along the digestive tract which often results in lower patient-to-patient pharmacokinetic variability (Pg. 6).
As discussed above, Elenko discloses wherein the activator and inhibitor may be given orally in capsules and other forms known in the art.
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the actives (i.e., xanomeline and trospium chloride) of Elenko to be in the form of beads prior to placing them into capsules motivated by the desire to achieve complex and adjustable release patterns as well as low patient-to-patient pharmacokinetic variability as taught by Sidwell.
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.
1. Claims 76-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 10,933,020 B2 (hereinafter ‘020) in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The instant claims and the patented claims are not patentably distinct insofar as they both disclose oral compositions comprising xanomeline tartrate beads and trospium chloride beads and wherein the compositions further comprise 3-[(4-hexyloxy)-1,2,5-thiadiazol-3-yl]-5-hydroxyl-1-methylpyridin-1-ium. The instant claims and the patented claims differ insofar as the patented claims recited a dosage of trospium chloride that is higher than that of the instant claims.
However, Elenko discloses a method of using a combination of one or more muscarinic agonists and one or more muscarinic antagonists for treatment of diseases that are ameliorated by activation of muscarinic receptors ( e.g., schizophrenia and related disorders); as well as a medicament comprising one or more muscarinic agonists and one or more muscarinic antagonists (col 1, line 24-30). Elenko specifically claims a single oral capsule comprising xanomeline and/or a salt thereof in an amount to cause a side effect chosen from nausea, vomiting, diarrhea, sweating and excess salivation; and trospium chloride in an amount effective to reduce the side effect associated with the oral administration of the xanomeline and/or the salt thereof (Ref. Claim 1). The formulation contains from 1 milligram to 1 gram of xanomeline and/or the salt thereof (Ref. Claim 5). The formulation contains from 1 milligram to 400 milligrams of trospium chloride (Ref. Claim 9). The salt of xanomeline is the salt of tartaric acid (Ref. Claim 15).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain trospium chloride in the amounts instantly claimed since such amounts are known to be effective amounts when in combination with muscarinic activators such as xanomeline as taught by Elenko.
2. Claims 76-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,925,832 B2 (hereinafter ‘832) in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The rational for rejecting the instant claims over the claims of the ‘832 patent is the same as that of the rejection over the ‘020 patent.
3. Claims 76-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,890,378 B2 (hereinafter ‘378) in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The rational for rejecting the instant claims over the claims of the ‘378 patent is the same as that of the rejection over the ‘020 patent.
4. Claims 76-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,452,692 B2 (hereinafter ‘692) in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The instant claims and the patented claims are not patentably distinct insofar as they both disclose oral compositions comprising xanomeline tartrate beads and trospium chloride beads. The instant claims and the patented claims differ insofar as the patented claims recite a method for treating a disorder such as schizophrenia and disclose dosages of xanomeline and trospium chloride that are higher than that of the instant claims.
However, Elenko discloses a method of using a combination of one or more muscarinic agonists and one or more muscarinic antagonists for treatment of diseases that are ameliorated by activation of muscarinic receptors ( e.g., schizophrenia and related disorders); as well as a medicament comprising one or more muscarinic agonists and one or more muscarinic antagonists (col 1, line 24-30). Elenko specifically claims a single oral capsule comprising xanomeline and/or a salt thereof in an amount to cause a side effect chosen from nausea, vomiting, diarrhea, sweating and excess salivation; and trospium chloride in an amount effective to reduce the side effect associated with the oral administration of the xanomeline and/or the salt thereof (Ref. Claim 1). The formulation contains from 1 milligram to 1 gram of xanomeline and/or the salt thereof (Ref. Claim 5). The formulation contains from 1 milligram to 400 milligrams of trospium chloride (Ref. Claim 9). The salt of xanomeline is the salt of tartaric acid (Ref. Claim 15).
Accordingly, it would have been obvious for one of ordinary skill in the art to have utilized the composition of the instant claims in methods to treat diseases such as schizophrenia since combinations xanomeline and trospium chloride are known to be effective in methods for treating such disorders as taught by Elenko. Furthermore, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to contain xanomeline and trospium chloride in the amounts instantly claimed since such amounts are known to be effective amounts when muscarinic activators and inhibitors are used in combination to treat diseases such as schizophrenia as taught by Elenko.
5. Claims 76-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,471,413 B2 (hereinafter ‘413) in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The rational for rejecting the instant claims over the claims of the ‘413 patent is the same as that of the rejection over the ‘692 patent.
6. Claims 76-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,238,643 B2 (hereinafter ‘643) in view of Sidwell et al. (Formulation: Developing Oral Controlled-Release Drug Products, Jul. 18, 2019) (hereinafter Sidwell).
The instant claims and the patented claims are not patentably distinct insofar as they both disclose oral compositions and capsules comprising xanomeline tartrate and trospium chloride. The instant claims and the patented claims differ insofar as the patented claims do not disclose wherein the xanomeline and trospium chloride are in the form of beads.
However, Sidwell discloses that small beads containing the API are placed in capsules where the beads can be prepared by various methods (Pg. 4). In contrast to tablets, capsules which contain beads can separate populations of beads (i.e., multiple pluralities of beads) to keep multiple APIs separate and to have them release at different times, achieving complex release patterns. Furthermore, because capsules package APIs as beads that behave independently, the dose or component release profile can be easily adjusted without affecting other product attributes. Finally, unlike tablets, capsule beads move gradually along the digestive tract which often results in lower patient-to-patient pharmacokinetic variability (Pg. 6).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the actives (i.e., xanomeline and trospium chloride) of the instant application to be in the form of beads prior to placing them into capsules motivated by the desire to achieve the complex and adjustable release patterns as well as the low patient-to-patient pharmacokinetic variability as taught by Sidwell.
7. Claims 76-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69-144 of copending Application No. 18/392,891 in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The instant claims and the patented claims are not patentably distinct insofar as they both disclose oral compositions comprising xanomeline tartrate beads and trospium chloride beads and wherein the compositions further comprise 3-[(4-hexyloxy)-1,2,5-thiadiazol-3-yl]-5-hydroxyl-1-methylpyridin-1-ium. The instant claims and the copending claims differ insofar as the copending claims further recite excipients.
However, Elenko discloses a method of using a combination of one or more muscarinic agonists and one or more muscarinic antagonists for treatment of diseases that are ameliorated by activation of muscarinic receptors ( e.g., schizophrenia and related disorders); as well as a medicament comprising one or more muscarinic agonists and one or more muscarinic antagonists (col 1, line 24-30). Suitable pharmaceutically acceptable carriers include excipients (col 5, line 50-53). Suitable carriers include sugars such as lactose as well as cellulose and its derivatives (col 5, line 59-63). The dosage forms may include one or more pharmaceutically-acceptable carriers (col 30, line 38-39). Elenko specifically claims a single oral capsule comprising xanomeline and/or a salt thereof in an amount to cause a side effect chosen from nausea, vomiting, diarrhea, sweating and excess salivation; and trospium chloride in an amount effective to reduce the side effect associated with the oral administration of the xanomeline and/or the salt thereof (Ref. Claim 1). The formulation contains from 1 milligram to 1 gram of xanomeline and/or the salt thereof (Ref. Claim 5). The formulation contains from 1 milligram to 400 milligrams of trospium chloride (Ref. Claim 9). The salt of xanomeline is the salt of tartaric acid (Ref. Claim 15).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of the instant claims to further contain excipients since they are known pharmaceutically acceptable carriers for use with medicaments comprising muscarinic activators and inhibitors such as xanomeline and trospium chloride as taught by Elenko.
This is a provisional nonstatutory double patenting rejection.
8. Claims 76-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-44 of copending Application No. 18,461,741 in view of Elenko et al. (US 10,369,144, Aug. 6, 2019) (hereinafter Elenko).
The rational for rejecting the instant claims over the copending claims is the same as that of the rejection over the ‘643 patent.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claims 80-81 appear to be free of the prior and remain rejected under nonstatutory double patenting.
Elenko is considered to be the closest prior art. Elenko’s teachings are discussed above. Elenko does not disclose, inter alia, wherein the composition comprises 0.1 to 0.25% 3-[(4-hexyloxy)-1,2,5-thiadiazol-3-yl]-5-hydroxyl-1-methylpyridin-1-ium and wherein the composition comprises less than 0.5 wt.% of 3-[(4-hexyloxy)-1,2,5-thiadiazol-3-yl]-5-hydroxyl-1-methylpyridin-1-ium after the oral pharmaceutical composition is stored for at least 3 months at 40 °C and 75% relative humidity.
Conclusion
Claims 76-83 are rejected.
Claims 84-99 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612