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 .
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.
Election/Restrictions
Applicant’s election of species without traverse in the reply filed on August 4th, 2025 is acknowledged.
Applicants provided a compliant species election of disease: a psychosis secondary to Parkinson’s disease.
Examiner found prior art for applicant elected species therefore the Markush search was not extended to other species according to Markush search practices.
The species reads on claims 1-3, 7-16, 21-23, 28 and 48.
Claims 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on July 21st, 2025.
Claims 1-3, 7-16, 21-23, 28 and 48 are examined on merits.
Current Status of 17/635,459
This office action is in response to the amended claims on 08/04/2025.
Claims 1-5 12-15,28 and 48 are original; claims 7-11,16 and 21-23 are previously amended.
Claims 1-3, 7-16, 21-23, 28 and 48 are examined in this office action.
Priority
The effective filing date is 08/15/2019 since the instant claims find support in provisional application no. 62/887,118.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 08/13/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-3, 7-16, 21-23, 28 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over
Parkinson et. al. (WO 2017/165635)
In view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Parkinson et.al teaches a method of treating Parkinson’s diseases (examiner is interpreting this as secondary psychosis related to Parkinson disease) (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1-3, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10)
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Although Parkinson et.al teaches method of administering pimavanserin in patients with Parkinson’s diseases psychosis, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patients with Parkinson’s diseases psychosis, Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with Parkinson disease’s psychosis and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat psychosis in patients with Parkinson disease because administering medication through nasogastric route would be easier for patients with Parkinson disease due to cognitive decline with psychosis. Administering pimavanserin through enteral is expected to require dissolving, mixing or sprinkling(claim 48) pimavanserin from capsule in liquid vehicle or in soft food for ease of administering pimavanserin to psychosis patients with Parkinson diseases, thus teaching claims 1-3, 7-10, 28 and 48.
Claims 11-15 recites different types of enteral feeding tubes(or gastric, nasoenteric and or enteric) , it would be obvious for a person skilled in the art to try different enteral feeding tubes to administer pimavanserin, since pimavanserin is known in the prior to be administered through nasogastric tubing, thus teaching claims 11-15.
Regarding claims 21-22 and 28, it would be expected for a person skilled in the art to experiment dissolving pimavanserin at different temperature to optimize concentration of pimavanserin in the liquid mixture to prevent pimavanserin from decomposition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 21-22 and 28) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Thus teaching claims 21-22 and 28.
Claims 1,7-10, 23, 28 and 48 are directed to concentration/ dosage of pimavanserin administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 1,7-10, 23, 28 and 48) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Applicant is asked to provide evidence of secondary considerations, such as surprising/unexpected results, for the full scope of instant claims 1, 28, and 48. Doing so will prevent Examiner from applying new obviousness rejections and will expedite allowance.
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 1-3, 7-16, 21-23, 28 and 48 rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1-11 of U.S. Patent No. US 7,659,285 B2 in view of
Parkinson et. al. (WO 2017/165635)
In further view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Reference claims 1-11 teaches a method of treating Parkinson’s disease psychosis in patient, comprising administrating to a N-(1-methylpiperidin-4-yl)-N-(4-flourophenylmethyl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide(pimavanserin) same as instant claims 1-3 . Reference claim 2-5 teaches administering pimavanserin from about 10mg to 50 mg which falls in the same range as instant claims 7-10. Reference claim 3 further teaches administering pimavanserin in about 10mg same as instant claim 10.
Parkinson et.al teaches a method of treating Parkinson’s diseases (examiner is interpreting this as secondary psychosis related to Parkinson disease) (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1-3, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10)
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach administering pimavanserin in liquid vehicle.
Although Parkinson et.al teaches method of administering pimavanserin in patients with Parkinson’s diseases psychosis, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patients with Parkinson’s diseases psychosis, Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with Parkinson disease’s psychosis and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of reference claims 1-11 and combine it with Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat psychosis in patients with Parkinson disease because administering medication through nasogastric route would be easier for patients with Parkinson disease due to cognitive decline with psychosis. Administering pimavanserin through enteral is expected to require dissolving, mixing or sprinkling (claim 48) pimavanserin from capsule in liquid vehicle or in soft food for ease of administering pimavanserin to psychosis patients with Parkinson diseases, thus teaching claims 1-3, 7-10, 28 and 48.
Claims 11-15 recites different types of enteral feeding tubes (or gastric, nasoenteric and or enteric) , it would be obvious for a person skilled in the art to try different enteral feeding tubes to administer pimavanserin, since pimavanserin is known in the prior to be administered through nasogastric tubing, thus teaching claims 11-15.
Regarding claims 21-22 and 28, it would be expected for a person skilled in the art to experiment dissolving pimavanserin at different temperature to optimize concentration of pimavanserin in the liquid mixture to prevent pimavanserin from decomposition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, temperature e will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 21-22 and 28) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Thus teaching claims 21-22 and 28.
Claims 1,7-10, 23, 28 and 48 are directed to concentration/ dosage of pimavanserin administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 1,7-10, 23, 28 and 48) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim 1, 7-16, 21-23, 28 and 48 rejected on the ground of obvious type nonstatutory double patenting as being unpatentable over claims, 1 and 10-15 of U.S. Patent No. US 7,713,995 B2 in view of
Parkinson et. al. (WO 2017/165635)
In further view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Reference claims 1 and 10-15 teaches a method of treating sleep disorder in patient, comprising administrating pimavanserin and pharmaceutically acceptable salt same as instant claims 1. Reference claim 10-15 teaches administering pimavanserin from about 0.001mg to 50 mg which falls in the same range as instant claims 7-10.
Parkinson et.al teaches a method of treating disorder (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10)
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach administering pimavanserin in liquid vehicle.
Although Parkinson et.al teaches method of administering pimavanserin in patients, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patient with disorder. Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with disorder and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of in reference claims 1 and 10-15 and combine it with Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat disorder in patients with because administering medication through nasogastric route would be easier for patients with disorder. Administering pimavanserin through enteral is expected to require dissolving, mixing or sprinkling (claim 48) pimavanserin from capsule in liquid vehicle or in soft food for ease of administering pimavanserin patients with disorder , thus teaching claims 1-3, 7-10, 28 and 48.
Claims 11-15 recites different types of enteral feeding tubes (or gastric, nasoenteric and or enteric) , it would be obvious for a person skilled in the art to try different enteral feeding tubes to administer pimavanserin, since pimavanserin is known in the prior to be administered through nasogastric tubing, thus teaching claims 11-15.
Regarding claims 21-22 and 28, it would be expected for a person skilled in the art to experiment dissolving pimavanserin at different temperature to optimize concentration of pimavanserin in the liquid mixture to prevent pimavanserin from decomposition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, temperature e will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 21-22 and 28) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Thus teaching claims 21-22 and 28.
Claims 1,7-10, 23, 28 and 48 are directed to concentration/ dosage of pimavanserin administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 1,7-10, 23, 28 and 48) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim 1, 7-16, 21-23, 28 and 48 rejected on the ground of obvious type nonstatutory double patenting as being unpatentable over claims, 1-2, and 4-24 of U.S. Patent No. US 7,732,462 B2 in view of
Parkinson et. al. (WO 2017/165635)
In further view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Reference claims 1-2, and 4-24 teaches a method of treating schizophrenia (disorder) in patient, comprising administrating pimavanserin same as instant claims 1. Reference claims 10-21 teaches administering pimavanserin from about 10 mg to 50 mg which falls in the same range as instant claims 1, 7-10. Reference claim 13, 16, 19 further teaches administering 10mg of pimavanserin, same as instant claim 10.
Parkinson et.al teaches a method of treating disorder (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10)
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach administering pimavanserin in liquid vehicle.
Although Parkinson et.al teaches method of administering pimavanserin in patients, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patient with disorder. Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with disorder and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of in reference claims 1-2, and 4-24 and combine it with Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat disorder in patients with because administering medication through nasogastric route would be easier for patients with disorder. Administering pimavanserin through enteral is expected to require dissolving, mixing or sprinkling (claim 48) pimavanserin from capsule in liquid vehicle or in soft food for ease of administering pimavanserin patients with disorder , thus teaching claims 1-3, 7-10, 28 and 48.
Claims 11-15 recites different types of enteral feeding tubes (or gastric, nasoenteric and or enteric) , it would be obvious for a person skilled in the art to try different enteral feeding tubes to administer pimavanserin, since pimavanserin is known in the prior to be administered through nasogastric tubing, thus teaching claims 11-15.
Regarding claims 21-22 and 28, it would be expected for a person skilled in the art to experiment dissolving pimavanserin at different temperature to optimize concentration of pimavanserin in the liquid mixture to prevent pimavanserin from decomposition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, temperature e will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 21-22 and 28) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Thus teaching claims 21-22 and 28.
Claims 1,7-10, 23, 28 and 48 are directed to concentration/ dosage of pimavanserin administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 1,7-10, 23, 28 and 48) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim 1, 7-16, 21-23, 28 and 48 rejected on the ground of obvious type nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US 7,994,193 B2 in view of
Parkinson et. al. (WO 2017/165635)
In further view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Reference claims 1-9 teaches a method of treating Alzheimer’s disease (disorder) in patient, comprising administrating pimavanserin same as instant claims 1. Reference claims 3-7 teaches administering pimavanserin from about 10 mg to 50 mg which falls in the same range as instant claims 1, 7-10. Reference claim 5 further teaches administering 10mg of pimavanserin, same as instant claim 10.
Parkinson et.al teaches a method of treating disorder (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10)
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach administering pimavanserin in liquid vehicle.
Although Parkinson et.al teaches method of administering pimavanserin in patients, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patient with disorder. Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with disorder and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of in reference claims 1-2, and 4-24 and combine it with Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat disorder in patients with because administering medication through nasogastric route would be easier for patients with disorder. Administering pimavanserin through enteral is expected to require dissolving, mixing or sprinkling (claim 48) pimavanserin from capsule in liquid vehicle or in soft food for ease of administering pimavanserin patients with disorder , thus teaching claims 1-3, 7-10, 28 and 48.
Claims 11-15 recites different types of enteral feeding tubes (or gastric, nasoenteric and or enteric) , it would be obvious for a person skilled in the art to try different enteral feeding tubes to administer pimavanserin, since pimavanserin is known in the prior to be administered through nasogastric tubing, thus teaching claims 11-15.
Regarding claims 21-22 and 28, it would be expected for a person skilled in the art to experiment dissolving pimavanserin at different temperature to optimize concentration of pimavanserin in the liquid mixture to prevent pimavanserin from decomposition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, temperature e will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 21-22 and 28) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Thus teaching claims 21-22 and 28.
Claims 1,7-10, 23, 28 and 48 are directed to concentration/ dosage of pimavanserin administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 1,7-10, 23, 28 and 48) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim 1, 7-16, 21-23, 28 and 48 rejected on the ground of obvious type nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US 8,008,323 B2 in view of
Parkinson et. al. (WO 2017/165635)
In further view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Reference claims 1-9 teaches a method of treating schizophrenia (disorder) in patient, comprising administrating pimavanserin same as instant claims 1. Reference claims 3-7 teaches administering pimavanserin from about 10 mg to 50 mg which falls in the same range as instant claims 1, 7-10. Reference claim 5 further teaches administering 10mg of pimavanserin, same as instant claim 10.
Parkinson et.al teaches a method of treating disorder (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10)
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach administering pimavanserin in liquid vehicle.
Although Parkinson et.al teaches method of administering pimavanserin in patients, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patient with disorder. Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with disorder and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of in reference claims 1-2, and 4-24 and combine it with Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat disorder in patients with because administering medication through nasogastric route would be easier for patients with disorder. Administering pimavanserin through enteral is expected to require dissolving, mixing or sprinkling (claim 48) pimavanserin from capsule in liquid vehicle or in soft food for ease of administering pimavanserin patients with disorder , thus teaching claims 1-3, 7-10, 28 and 48.
Claims 11-15 recites different types of enteral feeding tubes (or gastric, nasoenteric and or enteric) , it would be obvious for a person skilled in the art to try different enteral feeding tubes to administer pimavanserin, since pimavanserin is known in the prior to be administered through nasogastric tubing, thus teaching claims 11-15.
Regarding claims 21-22 and 28, it would be expected for a person skilled in the art to experiment dissolving pimavanserin at different temperature to optimize concentration of pimavanserin in the liquid mixture to prevent pimavanserin from decomposition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, temperature e will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 21-22 and 28) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Thus teaching claims 21-22 and 28.
Claims 1,7-10, 23, 28 and 48 are directed to concentration/ dosage of pimavanserin administered to patients. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals are routinely optimized based on body weight and body surface area (Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. Therefore, second treatment of compound I is considered to be routine optimization (thus teaching claims 1,7-10, 23, 28 and 48) “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim 1, 7-16, 21-23, 28 and 48 rejected on the ground of obvious type nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 8,227,487 B2 in view of
Parkinson et. al. (WO 2017/165635)
In further view of
Vanover et.al. (WO2008144665)
1. Determining the scope and contents of the prior art.
Reference claims 1-7 teaches a method of treating bipolar disorder (disorder) in patient, comprising administrating pimavanserin same as instant claims 1. Reference claims 3-7 teaches administering pimavanserin from about 0.001mg to 50 mg which falls in the same range as instant claims 1, 7-10. Reference claim 5 further teaches administering 10mg of pimavanserin, same as instant claim 10.
Parkinson et.al teaches a method of treating disorder (paragraph [0008]) by coadministration pimavanserin,
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(partially teaching claims 1, 7-9, 28 and 48) in the amount of 27mg, 20mg (claim 8), 23mg, 17mg (claim 9) (paragraph [0032] and [0034]) and CYP3A inhibitor (paragraph [123]) partially teaching claim 10).
Vanover teaches powdered pimavanserin is reconstituted in water (liquid vehicle of claims 1, 16, 23, 28 and 48) (paragraph [0063]). Vanover further teaches administration of pimavanserin via nasogastric tube (therefore enteral feeding tube paragraph [0061]), teaches claims 11-12 and 14. Vanover also teaches administration of 5mg to 100mg of pimavanserin once daily, in some embodiment 10mg (claim 10) and 20mg (claim 8) of pimavanserin once daily (paragraph [0059]).
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims do not teach administering pimavanserin in liquid vehicle.
Although Parkinson et.al teaches method of administering pimavanserin in patients, Parkinson does not teach method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
Although Vanover et.al teaches method of administering pimavanserin with enteral tube in patient with disorder. Vanover does not teaches method of administering to the patient about 2 mg to about 80 mg of pimavanserin once daily, wherein pimavanserin is dissolved in or mixed with about 5 mL to about 150 mL of a liquid vehicle at ambient or cold temperature before the administration.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who has sufficient knowledge in administering pimavanserin in patient with disorder and looking into developing dosage of pimavanserin to be administered to patient via enteral feeding tubing.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine the teaching of in reference claims 1-2, and 4-24 and combine it with Parkinson (combination of pimavanserin (Parkinson, paragraph [0032] and [0034]) and CYP3A inhibitor (Parkinson paragraph [123]) (1-3, 7-10, 28 and 48) with the teaching of Vanover (method of administering pimavanserin through enteral route (nasogastric tube, therefore enteral feeding tube (Vanover et.al paragraph [0061])) to treat disorder in patients with because administering medication through nasogastric route would be easier for patients with disorder. Administering pimavanserin through enteral is expected to require disso