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
Examiner have withdrawn 112 and 102(a)(1) rejections on record.
Examiner is maintaining 103 rejections with modification.
Applicants provided a compliant species election of disease: seizures or epilepsy.
Examiner found prior art on applicant’s elected species therefore election of species requirement is maintained.
Examiner is making this office action non-final because the anticipatory double patenting rejection did not include claim 20 of claims set of 08/19/2022.
Claims 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim.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 February 11th 2025.
Claims 1, 10-12, 14-19, and 21-28 are examined.
Current Status of 17/601,705
This Office Action is in response to the amended claims of 09/15/2025.
Claims 1,14, 18-19, 21-22, 24 are currenting amended; 11 and 15-17 are original; claims 10 and 23 are previously presented; and claims 25-28 are new.
Claims 4-5 are withdrawn.
Claims 1, 10-12, 14-19, and 21-28 examined in this office action.
Priority
Effected filing date is 04/05/2019 based on provisional application no. 62/830,012.
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.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 09/15/2025. Examiner have reviewed these remarks and amendments.
Regarding 112(b) and 112 (d) rejection:
Applicant have amended claim 1 by deleting the parentheticals.
Applicant cancelled claims 3 and 13.
This renders moot 112 rejection on record, thus 112 rejections are withdrawn
Regarding 102 rejections:
Applicant amended independent claim 1 by further limiting the scope of independent claim 1 with “… wherein the composition comprising allopregnanolone comprises a total dose of allopregnanolone in the range of about 0.25 mg/kg to about 25 mg/kg in a solution of sulfobutylether-β-cyclodextrin sodium salt in saline, wherein the total dose of allopregnanolone is administered intranasally in more than one smaller doses over a period of 1 to 5 minutes or 1 to 10 minutes, and wherein the condition is effectively treated or prevented for at least 6 hours after the composition is administered”.
This renders moot 102(a)(1) rejections on record, thus102(a)(1) rejections are withdrawn.
Regarding 103 rejections:
Applicant amended independent claim 1 by further limiting the scope of independent claim 1 with “wherein the composition comprising allopregnanolone comprises a total dose of allopregnanolone in the range of about 0.25 mg/kg to about 25 mg/kg in a solution of sulfobutylether-β-cyclodextrin sodium salt in saline, wherein the total dose of allopregnanolone is administered intranasally in more than one smaller doses over a period of 1 to 5 minutes or 1 to 10 minutes, and wherein the condition is effectively treated or prevented for at least 6 hours after the composition is administered”.
Applicant further argues:
Prior art of Sage et. al. does not teach currently amended claim 1. The prior art of Sage does not provide exemplified intranasal administration of allopregnanolone.
Prior art of Ducharme does not teach intranasal administration of allopregnanolone and fails to remedy the deficiencies of Sage.
Regarding independent claim 24, applicant alleges the prior art references of record do not teach intranasal administration of allopregnanolone and fails to remedy the deficiencies of Sage.
Examiners Response:
Examiner agrees, Sage et.al does not teach the amended claim 1 and Sage et.al does not provide exemplary method of intranasal administration of allopregnanolone. Although Ducharme does not teach administration of allopregnanolone, Ducharme does teach a method of administering pregnenolone intranasally to increase the concentration of pregnenolone in the olfactory region of the brain. It would be obvious for a person skilled in the art to administer allopregnanolone intranasally to increase level of allopregnanolone in olfactory region of the brain since intranasal administration of pregnenolone increases the concentration of pregnenolone in the olfactory region. Therefore intranasal administration of allopregnanolone will also increase the concentration of allopregnanolone in the olfactory region of the brain
Please note, applicant did not provide surprising/unexpected results. Therefore 103 rejections are maintained (see, below).
Regarding anticipatory double patenting rejection
Applicant amended independent claim 1 by further limiting the scope of independent claim 1 with “wherein the composition comprising allopregnanolone comprises a total dose of allopregnanolone in the range of about 0.25 mg/kg to about 25 mg/kg in a solution of sulfobutylether-β-cyclodextrin sodium salt in saline, wherein the total dose of allopregnanolone is administered intranasally in more than one smaller doses over a period of 1 to 5 minutes or 1 to 10 minutes, and wherein the condition is effectively treated or prevented for at least 6 hours after the composition is administered”.
This renders moot the anticipatory double patenting rejection. Thus anticipatory double patenting rejection is withdrawn.
Response to Amendment
Claim Rejections - 35 USC § 103 (maintained with modification)
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.
Claim(s) 1, 10-12, 14-19, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over
Sage (WO 2013/112605 A2)
In view of
DUCHARME, N et al. (Eur J Pharmacol 641(2-3). 01 September 2010).
In further view of
Brinton RD et.al. (PLoS One. 2015 Jun 3;10(6):e0128313. doi: 10.1371/journal.pone.0128313).
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Sage discloses a method of treating or preventing a condition susceptible to allopregnanolone selected from the group consisting of traumatic brain injury, Alzheimer's disease, mild cognitive impairment (MCI)), epilepsy(applicant’s elected species (page 22, line 7), seizures(applicant’s elected species), anxiety, fragile X tremorataxia syndrome, lysosomal storage disorders (Niemann-Pick type C disease), post-traumatic stress disorder (PTSD), postpartum depression (PPD), major depressive disorder (MDD), premenstrual dysphoric disorder (PMDD), persistent depressive disorder (PDD), bipolar disorder, seasonal affective disorder (SAD), secondary depression, post finasteride syndrome, alcohol craving, and smoking cessation, in a subject in need thereof, comprising administering to a human (page 69, line 14)(teaching claim 23) intranasally (page 64, line 26) (partially teaching claims 18, 22, 24, 25 and 27-28), a composition comprising of allopregnanolone (page 1, line 27) and a pharmaceutically acceptable excipient suitable for solubilizing allopregnanolone, wherein the pharmaceutically acceptable excipient is β-cyclodextrin, hydroxypropyl-β-cyclodextrin or sulfobutylether-β-cyclodextrin (page 1, line 29), or a combination thereof thus partially teaching claims 1. Sage further disclose sulfobutylether-β-cyclodextrin to be sulfobutylether-β-cyclodextrin sodium sulfonate salt (page 76, line 4-5).
Sage discloses wherein the condition susceptible to allopregnanolone is epilepsy or seizures (applicant’s elected species) wherein the seizures are acute seizures, tonic seizures, chronic seizures, or seizure clusters (page 22, lines 13-14) teaching claim 10-11. Sage further discloses wherein the epilepsy is status epilepticus or myoclonic epilepsy (page 22, line 7) teaching claim 12.
Ducharme discloses a method for selective delivery of pregnenolone to the olfactory bulb and adjacent structures, the method comprising intranasally administering a composition (page 2, third paragraph) comprising pregnenolone(precursor of allopregnanolone) (page 2, second paragraph), wherein, after intranasally administering, the concentration of pregnenolone in the olfactory blub and adjacent brain structures is higher compared to the concentration of pregnenolone in other regions of the brain or in the whole brain, the olfactory bulb is expected to have high concentrations of any material administered by the intranasal route, and the hippocampus, hypothalamus, and striatum also took up large amounts of pregnenolone (precursor to allopregnanolone) (page 7, first paragraph) (partially teaching claim 1 and 24).
Brinton et.al teaches administration of intranasal (1, 22, 24-25 and 27-28)formulation of allopregnanolone (page 5 line 5) in dosage of 3mg/kg and 10mg/kg (page 15 table 2) partially teaching claims 1 22, 24-25 and 27-28.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50.
2. Ascertaining the differences between the prior art and the claims at issue.
Sage does not teach a method for selective delivery of allopregnanolone to olfactory bulb and adjacent structure, where concentration of allopregnanolone is higher in the adjacent tissue.
Although Ducharme teaches a method for selective delivery of to olfactory bulb and adjacent structure. Ducharme does not disclose a composition comprising allopregnanolone and sulfobutylether-β-cyclodextririn .
Brinton does not teach intranasal composition of allopregnanolone with sulfobutylether-β-cyclodextrin.
Anisel et.al. does not teach intranasal administration of allopregnanolone with sulfobutylether-β-cyclodextrin.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan developing composition of allopregnanolone for intranasal delivery to increase the uptake of allopregnanolone is olfactory bulb and adjacent tissues.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to administer allopregnanolone intranasally for treating seizures because prior art Brinton teaches an intranasal administration allopregnanolone (Brinton et. al. page 15 table 2). Therefore, it would be obvious for a person skilled in the art use the composition comprising of allopregnanolone (Sage et.al. page 1, line 27) and a pharmaceutically acceptable excipient suitable for solubilizing allopregnanolone, wherein the pharmaceutically acceptable excipient is β-cyclodextrin, hydroxypropyl-β-cyclodextrin or sulfobutylether-β-cyclodextrin (Sage et.al. page 1, line 29), or a combination thereof in saline form and administer the composition intranasally Brinton et. al. page 15 table 2), for treating epilepsy or seizures (applicant’s elected species) wherein the seizures are acute seizures, tonic seizures, chronic seizures, or seizure clusters (Sage page 22, lines 13-14) Sage further discloses wherein the epilepsy is status epilepticus or myoclonic epilepsy (Sage page 22, line 7) thus teaching teaching claims 1 and 10-12. Sage further disclose sulfobutylether-β-cyclodextrin to be sulfobutylether-β-cyclodextrin sodium sulfonate salt (Sage page 76, line 4-5).
It would be expected intranasal administration of allopregnanolone will increases the concentration of allopregnanolone in the olfactory blub and adjacent brain structures would be higher compared to the concentration of allopregnanolone in other regions of the brain or in the whole brain because olfactory bulb is expected to have high concentrations of any material administered by the intranasal route (Ducharme et. al. , page 7, first paragraph) (teaching claim 24)
Regarding claims 1, 14-18 and 26 recites composition of allopregnanolone and sulfobutylether-β-cyclodextrin sodium salt to be in saline.
Furthermore claims 1,14-18 and 26 are drawn to concentration of allopregnanolone, sulfobutylether-β-cyclodextrin sodium salt and saline. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. 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. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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).
Claims 1, 19-22 and 27-28 are drawn to dosage of allopregnanolone, frequency of the dosage of allopregnanolone and effectiveness of the dosage. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. 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. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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).
Regarding claim 24, it would be obvious for one of ordinary skill in the art to administer composition of allopregnanolone with sulfobutylether-β-cyclodextrin sodium salt intranasally (Sage page 64, line 26 and page 69 line) is similar to that of delivering into olfactory blub as administration of pregnenolone intranasally from the teaching of Ducharme (Ducharme, page 2, third paragraph). Therefore, it is expected intranasal delivery of composition comprising of allopregnolone with sulfobutylether-β-cyclodextrin(Sage page 64, line 26 and page 69 line) would increase the concentration of allopregnolone in the surrounding tissue of olfactory bulb same as delivery of allogregnolone without sulfobutylether-β-cyclodextrin(Ducharme, page 2, third paragraph) for the treatment of seizure (applicant’s elected species), thus teaching claim 24.
Therefore, it would be prima facia to combine the teaching of Sage et.al and Brinton et.al with the teaching Ducharme and Anisel to teach claims 1, 10-12, 14-19, and 21-28.
Applicants are asked to provide evidence of secondary considerations, such as surprising/unexpected results, that encompass the full scope of independent claims 1 and 24, in order to mitigate the chance that future obviousness rejections can be made.
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, 14-19, and 21-28 are rejected on the ground of obviousness-type nonstatutory double patenting as being obvious over claim 1-3 of U.S. Patent No.10,251,894.
In view of
Sage (WO 2013/112605 A2)
In view of
DUCHARME, N et al. (Eur J Pharmacol 641(2-3). 01 September 2010).
In further view of
Brinton RD et.al. (PLoS One. 2015 Jun 3;10(6):e0128313. doi: 10.1371/journal.pone.0128313).
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
Instant claim of 08/19/22 was used to write this rejection.
1. Determining the scope and contents of the prior art.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-3 disclose a method of treating postpartum depression comprising allopregnanolone and sulfobuthether-β-cyclodextrin salt in human (reference claim 2, same as instant claim 23) same as instant claims 1 which teaches a method of treating diseases including postpartum depression using allopregnanolone and sulfobuthether-β-cyclodextrin salt.
Sage discloses a method of treating or preventing a condition susceptible to allopregnanolone selected from the group consisting of traumatic brain injury, Alzheimer's disease, mild cognitive impairment (MCI)), epilepsy(applicant’s elected species (page 22, line 7), seizures(applicant’s elected species), anxiety, fragile X tremorataxia syndrome, lysosomal storage disorders (Niemann-Pick type C disease), post-traumatic stress disorder (PTSD), postpartum depression (PPD), major depressive disorder (MDD), premenstrual dysphoric disorder (PMDD), persistent depressive disorder (PDD), bipolar disorder, seasonal affective disorder (SAD), secondary depression, post finasteride syndrome, alcohol craving, and smoking cessation, in a subject in need thereof, comprising administering to a human (page 69, line 14)(teaching claim 23) intranasally (page 64, line 26) (partially teaching claims 18, 22, and 24), a composition comprising of allopregnanolone (page 1, line 27) and a pharmaceutically acceptable excipient suitable for solubilizing allopregnanolone, wherein the pharmaceutically acceptable excipient is β-cyclodextrin, hydroxypropyl-β-cyclodextrin or sulfobutylether-β-cyclodextrin (page 1, line 29), or a combination thereof thus partially teaching claims 1. Sage further disclose sulfobutylether-β-cyclodextrin to be sulfobutylether-β-cyclodextrin sodium sulfonate salt (page 76, line 4-5).
Ducharme discloses a method for selective delivery of pregnenolone to the olfactory bulb and adjacent structures, the method comprising intranasally administering a composition (page 2, third paragraph) comprising pregnenolone(precursor of allopregnanolone) (page 2, second paragraph), wherein, after intranasally administering, the concentration of pregnenolone in the olfactory blub and adjacent brain structures is higher compared to the concentration of pregnenolone in other regions of the brain or in the whole brain, the olfactory bulb is expected to have high concentrations of any material administered by the intranasal route, and the hippocampus, hypothalamus, and striatum also took up large amounts of pregnenolone (precursor to allopregnanolone) (page 7, first paragraph) (partially teaching claim 24).
Brinton et.al teaches administration of intranasal formulation of allopregnanolone (page 5 line 5) in dosage of 3mg/kg and 10mg/kg (page 15 table 2) partially teaching claims 1 and 24-25.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50.
2. Ascertaining the differences between the prior art and the claims at issue.
Sage does not teach a method for selective delivery of allopregnanolone to olfactory bulb and adjacent structure, where concentration of allopregnanolone is higher in the adjacent tissue.
Although Ducharme teaches a method for selective delivery to olfactory bulb and adjacent structure. Ducharme does not disclose a composition comprising allopregnanolone and sulfobutylether-β-cyclodextririn .
Brinton does not teach intranasal composition of allopregnanolone with sulfobutylether-β-cyclodextrin.
Anisel et.al. does not teach intranasal administration of allopregnanolone with sulfobutylether-β-cyclodextrin.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan developing composition of allopregnanolone for intranasal delivery to increase the uptake of allopregnanolone is olfactory bulb and adjacent tissues.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to administer allopregnanolone tranasally for treating seizers because prior art Brinton teaches an intranasal administration allopregnanolone (Brinton et. al. page 15 table 2) with reference claims 1-3. Therefore, it would be obvious for a person skilled in the art use the composition comprising of allopregnanolone (Sage et.al. page 1, line 27) and a pharmaceutically acceptable excipient suitable for solubilizing allopregnanolone, wherein the pharmaceutically acceptable excipient is β-cyclodextrin, hydroxypropyl-β-cyclodextrin or sulfobutylether-β-cyclodextrin (Sage et.al. page 1, line 29), or a combination thereof in saline form and administer the composition intranasally( Brinton et. al. page 15 table 2), for treating epilepsy or seizures (applicant’s elected species) wherein the seizures are acute seizures, tonic seizures, chronic seizures, or seizure clusters (Sage page 22, lines 13-14) Sage further discloses wherein the epilepsy is status epilepticus or myoclonic epilepsy (Sage page 22, line 7) thus teaching teaching claims 1. Sage further disclose sulfobutylether-β-cyclodextrin to be sulfobutylether-β-cyclodextrin sodium sulfonate salt (Sage page 76, line 4-5).
It would be expected intranasal administration of allopregnanolone will increases the concentration of allopregnanolone in the olfactory blub and adjacent brain structures would be higher compared to the concentration of allopregnanolone in other regions of the brain or in the whole brain because olfactory bulb is expected to have high concentrations of any material administered by the intranasal route (Ducharme et. al. , page 7, first paragraph) (teaching claim 24)
Regarding claims 1, 14-18 and 26 recites composition of allopregnanolone and sulfobutylether-β-cyclodextrin sodium salt to be in saline.
Furthermore claims 1,14-18 and 26 are drawn to concentration of allopregnanolone, sulfobutylether-β-cyclodextrin sodium salt and saline. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. 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. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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).
Claims 1, 19-22 and 27-28 are drawn to dosage of allopregnanolone, frequency of the dosage of allopregnanolone and effectiveness of the dosage. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. 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. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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).
Regarding claim 24, it would be obvious for one of ordinary skill in the art to administer composition of allopregnanolone with sulfobutylether-β-cyclodextrin sodium salt intranasally (Sage page 64, line 26 and page 69 line) is similar to that of delivering into olfactory blub as administration of pregnenolone intranasally from the teaching of Ducharme (Ducharme, page 2, third paragraph). Therefore, it is expected intranasal delivery of composition comprising of allopregnolone with sulfobutylether-β-cyclodextrin(Sage page 64, line 26 and page 69 line) would increase the concentration of allopregnolone in the surrounding tissue of olfactory bulb same as delivery of allogregnolone without sulfobutylether-β-cyclodextrin(Ducharme, page 2, third paragraph) for the treatment of seizure (applicant’s elected species), thus teaching claim 24.
Conclusion
No claims are allowable as written.
Please note, prior art of Brinton discloses use of allopregnanolone increases neurogenesis while simultaneously reduces Alzheimer’s related pathology(Brinton page 2, paragraph 2). This indicates there are prior art for other species of diseases in claim 1.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625