Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of the Claims
Claims 34-53 are currently pending and are under examination.
Duplicate Claims, Warning
Applicant is advised that should claims 34 and 39 be found allowable, claims 52 and 53 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 34-44 and 46-53 are rejected under 35 U.S.C. 102(b) as being anticipated by JP2008115172 (cited in IDS filed on 10/7/2024; English translation cited and provided during the prosecution of the parent case, 18/455757).
JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as post-traumatic stress disorder (PTSD) in a patient (p5, item 7: 1st compound, p7, items 10-11, p17, para 6, and p24, example 1).
JP2008115172 also discloses the use of the above compound in combination with a drug (drug II) selected from: serotonin reuptake inhibitor, serotonin and norepinephrine reuptake inhibitors or anti-anxiety drugs; and medicaments and pharmaceutical preparations thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination.
As to claims 35-40, 51 and 53, JP2008115172 discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, citalopram, duloxetine, escitalopram (p18, para 2).
As to claims 41-44, JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4).
As to claims 46-47, JP2008115172 discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam; and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5).
JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
As such, the instant claims are anticipated by JP2008115172.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 34-44 and 46-53 are rejected under 35 U.S.C. 103(a) as being unpatentable over YAMASHITA et al. (WO 2006/112464 A1; cited in IDS filed on 10/7/2024) in view of CLARK et al. (US 2005/0043309 A1; cited in IDS filed on 10/7/2024).
YAMASHITA teaches a method for treating central nervous system disorders such as major depression, melancholic depression, post-traumatic stress disorder (PTSD), comprising administering to human a pharmaceutical composition (p13, line 16-23; and p14, line 3-5, claims 10-11), which comprises: a compound (I) as active agent, preferably, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one (
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, claimed compound) and a pharmaceutically acceptable carrier (p69, Example 1; p12, line 10-14, claim 7, 1st compound, p13, line 24-p14, line 9, p15, lines 4-8 and claims 9-11).
YAMASHITA also teaches that the compound (I) set forth above has D2 receptor partial agonist effect, 5-HT2A receptor antagonist effect and serotonin reuptake inhibitory effect, and is effective for improving depressive symptoms without developing side effects (abstract, p3, lines 9-25 and p41, line 28 to p44, line 7).
YAMASHITA does not specifically teach the combination with a drug selected from: serotonin reuptake inhibitor, serotonin and norepinephrine reuptake inhibitors or anti-anxiety drugs.
However, it was known in the art that for treatment of CNS disorders such as depression and PTSD, one or more other antidepressants (e.g., serotonin reuptake inhibitor, serotonin and noradrenaline reuptake inhibitors) or anti-anxiety agents can be used in combination with other active compounds useful for the same CNS disorders as evidenced by CLARK.
CLARK teaches a method for treating CNS disorders such as major depression and PTSD comprising administering to a mammal in need of such treatment a compound such as 7-[4-(4-Benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-[1,8]-naphthyridin-2-one as shown below ([0020], [0022], line 1-5; [0615]; and [0628] [0024]; [0468] & [1443]):
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.
The above compound share almost identical structure with claimed compound except for having [1,8]naphthyridin-2-ones instead of 1H-quinolin-2-one.
CLARK also teaches that for the treatment of the CNS disorders, the above compound can be used in conjunction with other active agents, i.e., anti-depressants including selective serotonin reuptake inhibitors (SSRI) and serotonin and noradrenaline reuptake inhibitors (SNRIs) and anti-anxiety agents ([0622] and [0623]). CLARK further teaches that examples of suitable selective serotonin reuptake inhibitors include fluoxetine, fluvoxamine, paroxetine and sertraline ([0622]). CLARK further teaches that suitable serotonin and noradrenaline (norepinephrine) reuptake inhibitors of use in the present invention include venlafaxine ([0622]). CLARK further teaches that suitable classes of anti-anxiety agents include benzodiazepines and serotonin 1A (5-HT1A) agonists or antagonists wherein suitable benzodiazepines include alprazolam, chlordiazepoxide, clonazepam, chlorazepate, diazepam, halazepam, lorazepam, oxazepam, and prazepam; and suitable 5-HT1A receptor agonists or antagonists include buspirone, flesinoxan, gepirone and ipsapirone ([0623]).
In addition, CLARK teaches that the compound and the other active agents are administered together as part of the same pharmaceutical composition (single formulation), or are administered separately as part of an appropriate dose regimen designed to obtain the benefits of the combination therapy ([0676]).
CLARK teaches a pharmaceutical composition, which further comprises a pharmaceutically acceptable carrier ([0020], [0023] and claim 38).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the compound (I): 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one in combination with known anti-depressants such as selective serotonin reuptake inhibitors (SSRI) and serotonin and noradrenaline reuptake inhibitors (SNRIs) or anti-anxiety drugs for treating CNS diseases such as PTSD as taught by CLARK because YAMASHITA teaches that the active compound (I) such as 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one is effective for treating the same CNS disorders including PTSD while having less side effects and excellent tolerability and safety as compared to those well-known typical and atypical anti-psychotic drugs. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, one would have been motivated to combine 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one with the well-known anti-depressants or anti-anxiety drugs on their independent efficacy in treating CNS disorders such as PTSD. One would have a reasonable expectation of success, as noted above, that two independently successful treatments would be similarly successful when combined.
Claim 45 is rejected under 35 U.S.C. 103(a) as being unpatentable over YAMASHITA et al. (WO 2006/112464 A1; cited in IDS filed on 10/7/2024) in view of CLARK et al. (US 2005/0043309 A1; cited in IDS filed on 10/7/2024) in further view of Rao et al. (US 2009/0048233).
YAMASHITA et al. and CLARK et al. as applied supra are herein applied for the same teachings in their entirety.
YAMASHITA et al. and CLARK et al. do not specifically disclose desvenlafaxine. However, it was well known in the art that desvenlafaxine (4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol) is an isolated active metabolite of venlafaxine and the indications for desvenlafaxine are expected to be similar to those of venlafaxine as evidence by Rao et al. ([0043]). Also, Rao et al. teach that desvenlafaxine is a SNRI along with venlafalzine and duloxetine and could be used in combination with other therapeutic agents for the treatment of the same CNS disorders such as depression, anxiety disorder and post-traumatic stress disorder (abstract, [0025], [0040], claims 1 and 37-38). Rao et al. further teach that the symptoms of PTSD can range from constantly reliving the event to a general emotional numbing and persistent anxiety, exaggerated startle reactions, difficulty concentrating, nightmares, and insomnia are common ([0124]).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the compound (I): 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one in combination with known serotonin and noradrenaline reuptake inhibitors (SNRIs) such as desvenlafaxine for treating the same CNS diseases such as PTSD as taught by CLARK. Also, CLARK already teaches that for the treatment of CNS disorders such as major depression and post-traumatic stress disorder, the compound can be used in conjunction with other active agents, i.e., anti-depressants including selective serotonin reuptake inhibitors (SSRI) and serotonin and noradrenaline reuptake inhibitors (SNRIs) and anti-anxiety agents ([0622] and [0623]) wherein suitable serotonin and noradrenaline (norepinephrine) reuptake inhibitors (SNRI) include venlafaxine ([0622]). The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 34-53 are rejected under 35 U.S.C. 103(a) as being unpatentable over JP2008115172 in view of Rao et al. (US 2009/0048233).
JP2008115172 as applied supra is herein applied for the same teachings in their entirety.
JP2008115172 does not specifically disclose desvenlafaxine recited in claim 45. However, it was well known in the art that desvenlafaxine (4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol) is an isolated active metabolite of venlafaxine and the indications for desvenlafaxine are expected to be similar to those of venlafaxine as evidence by Rao et al. ([0043]). Also, Rao et al. teach that desvenlafaxine is a SNRI along with venlafalzine and duloxetine and could be used in combination with other therapeutic agents for the treatment of the same CNS disorders such as depression, anxiety disorder and post-traumatic stress disorder (abstract, [0025], [0040], claims 1 and 37-38). Rao et al. further teach that the symptoms of PTSD can range from constantly reliving the event to a general emotional numbing and persistent anxiety, exaggerated startle reactions, difficulty concentrating, nightmares, and insomnia are common ([0124]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the compound (I): 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one in combination with known serotonin and noradrenaline reuptake inhibitors (SNRIs) such as desvenlafaxine for treating the same CNS diseases such as PTSD because JP2008115172 already teaches and suggests the combination of the compound (I) with a SNRI such as venlafalzine and desvenlafaxine is taught to be isolated active metabolite of venlafaxine and a SNRI. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs in the same way as the other SNRI such as venlafalzine.
Non-Statutory Double Patenting Rejections
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 34-44 and 46-53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 9,480,686, which has the same assignee, in view of JP2008115172.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the following reasons.
The claims of the patent are drawn to a method for treating post-traumatic stress disorder (PTSD) comprising administering to a patient in need thereof the claimed compound, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one.
The claims of the patent do not specifically recite the combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug as claimed.
However, JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as PTSD, endogenous depression, major depression, melancholic and treatment resistant depression (p5, item 7: 1st compound, p7, items 10-11, p17, para 6, and p24, example 1). JP2008115172 also discloses the use of the compound in combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug; and medicament and pharmaceutical preparation thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination. JP2008115172 further discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, milnacipran, citalopram, duloxetine, and escitalopram (p18, para 2). JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4). JP2008115172 further discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam, and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5). In addition, JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the claimed compound (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one) in combination with a drug such as a selective serotonin reuptake inhibitor (SSRI), a serotonin and noradrenaline reuptake inhibitor (SNRIs) and an anti-anxiety agent for treating CNS disorders such as post-traumatic stress disorder and depression because JP2008115172 teaches, motivate or suggest such combination in the treatment of those CNS disorders. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, the instant claims would have been obvious over the claims of the patent in view of JP2008115172.
Claims 34-44 and 46-53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 3-18 of U.S. Patent No. 9,839,637, which has the same assignee, in view of JP2008115172.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the following reasons.
The claims of the patent are drawn to a pharmaceutical composition comprising claimed compound, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one, and a method for treating a CNS disorder such as depression and schizophrenia comprising administering the claimed compound to a patient in need thereof.
The claims of the patent do not specifically recite the combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug and the treatment of PTSD as claimed.
However, JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as PTSD as well as schizophrenia and major depression (p5, item 7: 1st compound, p7, items 1011, p17, para 6, and p24, example 1). JP2008115172 also discloses the use of the compound in combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug; and medicament and pharmaceutical preparation thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination. JP2008115172 further discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, milnacipran, citalopram, duloxetine, and escitalopram (p18, para 2). JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4). JP2008115172 further discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam, and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5). In addition, JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the claimed compound (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one) in combination with a drug such as a selective serotonin reuptake inhibitor (SSRI), a serotonin and noradrenaline reuptake inhibitor (SNRIs) and an anti-anxiety agent, which were taught to be effective for treating CNS disorders such as PTSD as well as schizophrenia and depression because JP2008115172 teaches, motivate or suggest such combination in the treatment of those CNS disorders. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, the instant claims would have been obvious over the claims of the patent in view of JP2008115172.
Claims 34-44 and 46-53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 9,206,167, which has the same assignee, in view of JP2008115172.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the following reasons.
The claims of the patent are drawn to a method for treating a CNS disorder such as bipolar I type disorder and bipolar II type disorder comprising administering to a patient in need thereof the claimed compound, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one.
The claims of the patent do not specifically recite the combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug and the treatment of PTSD as claimed.
However, JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as PTSD, endogenous depression, major depression, melancholic and treatment resistant depression as well as bipolar disorder (p5, item 7: 1st compound, p7, item 10, p17, para 6, and p24, example 1). JP2008115172 also discloses the use of the compound in combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug; and medicament and pharmaceutical preparation thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination. JP2008115172 further discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, milnacipran, citalopram, duloxetine, and escitalopram (p18, para 2). JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4). JP2008115172 further discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam, and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5). In addition, JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the claimed compound (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one) in combination with a drug such as a selective serotonin reuptake inhibitor (SSRI), a serotonin and noradrenaline reuptake inhibitor (SNRIs) and an anti-anxiety agent for treating CNS disorders such as PTSD as well as bipolar disorders and depression because JP2008115172 teaches, motivate or suggest such combination in the treatment of those CNS disorders. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, the instant claims would have been obvious over the claims of the patent in view of JP2008115172.
Claims 34-44 and 46-53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8,618,109, which has the same assignee, in view of JP2008115172.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the following reasons.
The claims of the patent are drawn to a method for treating a CNS disorder such as schizophrenia comprising administering to a patient in need thereof the claimed compound, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one.
The claims of the patent do not specifically recite the combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug and the treatment of PTSD as claimed.
However, JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as PTSD, endogenous depression, major depression, melancholic and treatment resistant depression as well as schizophrenia (p5, item 7: 1st compound, p7, items 10-11, p17, para 6, and p24, example 1). JP2008115172 also discloses the use of the compound in combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug; and medicament and pharmaceutical preparation thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination. JP2008115172 further discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, milnacipran, citalopram, duloxetine, and escitalopram (p18, para 2). JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4). JP2008115172 further discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam, and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5). In addition, JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the claimed compound (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one) in combination with a drug such as a selective serotonin reuptake inhibitor (SSRI), a serotonin and noradrenaline reuptake inhibitor (SNRIs) and an anti-anxiety agent which were taught to be effective for treating CNS disorders such as PTSD as well as schizophrenia because JP2008115172 teaches, motivate or suggest such combination in the treatment of those CNS disorders. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, the instant claims would have been obvious over the claims of the patent in view of JP2008115172.
Claims 34-44 and 46-53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 and 4-5 of U.S. Patent No. 8,349,840, which has the same assignee, in view of JP2008115172.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the following reasons.
The claims of the patent are drawn to a pharmaceutical composition comprising claimed compound, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one, and a method for treating a CNS disorder such as depression, endogenous depression, major depression, melancholy and refractory depression comprising administering to a patient in need thereof the claimed compound.
The claims of the patent do not specifically recite the combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug and the treatment of PTSD as claimed.
However, JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as PTSD, endogenous depression, major depression, melancholic and treatment resistant depression (p5, item 7: 1st compound, p7, items 10-11, p17, para 6, and p24, example 1). JP2008115172 also discloses the use of the compound in combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug; and medicament and pharmaceutical preparation thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination. JP2008115172 further discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, milnacipran, citalopram, duloxetine, and escitalopram (p18, para 2). JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4). JP2008115172 further discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam, and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5). In addition, JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the claimed compound (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one) in combination with a drug such as a selective serotonin reuptake inhibitor (SSRI), a serotonin and noradrenaline reuptake inhibitor (SNRIs) and an anti-anxiety agent, which were taught to be effective for treating CNS disorders such as PTSD as well as depression, endogenous depression, major depression, melancholy and refractory depression because JP2008115172 teaches, motivate or suggest such combination in the treatment of those CNS disorders. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, the instant claims would have been obvious over the claims of the patent in view of JP2008115172.
Claims 34-44 and 46-53 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 13, 19, and 21 of co-pending application 18/785196 in view of JP2008115172.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the following reasons.
The claims of the co-pending application are drawn to a method for treating impulsive symptoms associated with mental disease (CNS disorders) such as PTSD comprising administering to a patient in need thereof the claimed compound, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one.
The claims of the co-pending application do not specifically recite the combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug as claimed.
However, JP2008115172 discloses 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one for use in the treatment of CNS diseases such as PTSD, endogenous depression, major depression, melancholic and treatment resistant depression (p5, item 7: 1st compound, p7, items 10-11, p17, para 6, and p24, example 1). JP2008115172 also discloses the use of the compound in combination with a drug selected from: a serotonin reuptake inhibitor, a serotonin and norepinephrine reuptake inhibitor, or an antianxiety drug; and medicament and pharmaceutical preparation thereof (p17, para 8-p18, para 5). Such combinational use implicitly discloses the compound and said drug are administered in a single formulation or in separate formulations to be administered simultaneously or different time points as those two options are the only ways to use two drugs in combination. JP2008115172 further discloses that serotonin reuptake inhibitors include fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, milnacipran, citalopram, duloxetine, and escitalopram (p18, para 2). JP2008115172 discloses that serotonin and norepinephrine reuptake inhibitors include venlafaxine, duloxetine and milnacipran (p18, para 4). JP2008115172 further discloses that anti-anxiety drugs include benzodiazepine anxiolytics such as diazepam, chlordiazepoxide, cloxazolam, clothiazepam, alprazolam, ethazolam, and oxazolam, and serotonin 5-HT1A receptor agonist anti-anxiety drugs include tandospirone and buspirone (p18, para 5). In addition, JP2008115172 discloses a pharmaceutical composition comprising the medicament and a pharmaceutically acceptable carrier (p7, item 14 and claims 12-13).
Thus, it would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to use the claimed compound (7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one) in combination with a drug such as a selective serotonin reuptake inhibitor (SSRI), a serotonin and noradrenaline reuptake inhibitor (SNRIs) and an anti-anxiety agent which were taught to be effective for treating CNS disorders such as PTSD and depression because JP2008115172 teaches, motivate or suggest such combination in the treatment of those CNS disorders. The skilled artisan would have been motivated to do so on the reasonable expectation of success for obtaining combined effects from both drugs. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, the instant claims would have been obvious over the claims of the co-pending application in view of JP2008115172.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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