DETAILED ACTION
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.
Status of the Claims
Claims 51, 76, and 84-110 are pending and under consideration in this action. Claims 1-50, 52-75, and 77-83 are cancelled. Claims 84-110 are newly added.
Change in Examiner
The examiner for your application in the USPTO has changed. Examiner Monica Shin can be reached at 571-272-7138.
Election/Restrictions
Applicant’s election without traverse of Group II (Claims 51, 76, and 84-110) in the reply filed on September 25, 2025 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 51, 76, and 84-110 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of certain neurological conditions, does not reasonably provide enablement for prevention and/or treatment of all neurological conditions encompassed by the claims (e.g., some of those explicitly recited in claims 76 and 108-110). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
An analysis based upon the most relevant Wands factors is set forth below.
To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman (230 USPQ 546, 547 (Bd. Pat App Int 1986)). They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims.
Breadth of Claims and Nature of the Invention/Statue of the Prior Art
Applicant’s claims are broad, particularly with regards to the neurological conditions being treated and/or prevented. The claims as currently written encompass both treatment and prevention of, for example, the specific neurological conditions explicitly recited in claim 108. Furthermore, it is noted that the Specification defines “treating” and “treatment” to also encompass “preventing the disease or condition from occurring in a mammal” (P.G. Pub., par.0053).
As evidenced by, for example, claim 108, the term “neurological condition” encompasses conditions that are genetic (no known prevention methods), conditions known in the art that does not have method of prevention due to the etiology not necessarily being known or the unpredictable nature of the condition (e.g., Alzheimer’s disease, Parkinson’s disease, traumatic brain injury), and conditions that do not have any known treatment in the art.
Harvard Health Publishing (Partial seizures (focal seizures), published Dec. 1, 2025), a post-filing art, discloses that when it comes to partial seizures, if you have epilepsy, the best way to prevent seizures is to take prescribed antiseizure medicines without missing doses. However, even when medicine is working well, some seizures cannot be prevented (p.5, Preventing partial seizures).
Woodcock (What Is Post-Finasteride Syndrome (PFS), and Is It Permanent?, published Dec. 12, 2025), also post-filing art, discloses that there isn’t a specific treatment for PFS (p.1, Key takeaways, 3rd bullet point).
Boston Children’s Hospital (CDKL5 Disorder; © 2025-2026), also post-filing art, discloses that CDKL5 Disorder is caused by a variant in the CDKL5 gene (p.4, para.1). There is no currently targeted treatment or gene therapy for CDKL5 disorder (p.5, How is CDKL5 disorder treated?).
Cleveland Clinic (Postpartum Depression; published March 26, 2026), also post-filing art, discloses that postpartum depression isn’t entirely preventable (p.6, Can postpartum depression be prevented?).
Level of One of Ordinary Skill & Predictability/Unpredictability in the Art
MPEP 2141.03 states (in part), “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering).
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Guidance/Working Examples
While the Specification appears to provide examples of the formulation itself, there does not appear to be any guidance of working examples of the methods as claimed. Example 11, for example, appears to disclose the study design of the extended-release brexanolone for the prevention of postpartum depression (PPD). However, the example does not provide any results to demonstrate whether performing the method actually resulted in prevention of PPD as claimed, but rather, merely notes what the primary endpoints to be measured are, and descriptive statistics that will be presented (but does not appear yet to be presented).
Furthermore, Applicant does not provide any additional guidance or working examples of any of the other claimed neurological conditions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 51, 84-86, 88, 89, 95, 98, 100, 101, and 108-110 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saporito et al. (Saporito) (US 2018/0296487 A1; published Oct. 18, 2018).
With regards to Claims 51 and 108-110, Saporito discloses a sustained release injectable neurosteroid formulation comprising neurosteroid particles having a D50 (volume weighted median diameter) of less than 10 microns, such as between 1-5 microns, and the neurosteroid particles comprising a pregnane neurosteroid, at least one surface stabilizer, and an additional surface stabilizer such as a surfactant (para.0004, 0022-0025, 0152; Saporito claim 10).
The neurosteroid is allopregnanolone (also known as brexanolone) (para.0026, 0049; Saporito claim 10).
The sustained release formulations may also be considered long acting in that they provide an effective amount of neurosteroid in vivo for an extended time after administration (reading on extended release injectable formulation) (para.0004).
The formulation comprises the neurosteroid particles in an aqueous suspension (para.0004).
Saporito further discloses a method of treating a patient having inter alia a seizure disorder, such as infantile spasms, or postpartum depression, comprising administering an effective amount of the sustained release injectable neurosteroid formulation to a patient suffering from the condition (para. 0027, 0107-0111; Saporito claims 15-17).
The sustained release injectable neurosteroid formulations may contain pharmaceutically acceptable excipients, such as suspending agents (para.0090).
The formulation may contain tonicity adjusting agents so that it is isotonic with human plasma (para.0089).
The formulation additionally comprises a buffer (para.0085).
The sustained release injectable neurosteroid (e.g., allopregnanolone, also known as brexanolone) formulations are suitable for, for example, intramuscular and subcutaneous administration. Saporito discloses that it has been surprisingly discovered that injectable suspensions of neurosteroid particles containing neurosteroid and at least one polymeric surface stabilizer provide high brain levels of neurosteroid (para.0070). The sustained release formulations also have a longer neurosteroid half-life in vivo than immediate release neurosteroid formulation (para.0004).
With regards to Claim 84, Saporito discloses that the sustained release injectable neurosteroid formulations may contain any pharmaceutically acceptable excipient compatible with the neurosteroid and capable of providing the desired pharmacological release profile for the dosage form. Saporito defines “release profile” to be the graph of neurosteroid concentration in plasma, blood, or a specific tissue, such as brain, versus time after administration (para.0090).
The sustained release dosage forms may be “depot” formulations having a release profile in which the neurosteroid reaches a therapeutically effective concentration in plasma soon after injection and remains at an effective plasma concentration of at least 72 hours (para.0090).
With regards to Claims 85 and 86, the sustained injectable neurosteroid formulations contain the neurosteroid at a concentration of about 200 mg/ml (para.0083).
With regards to Claims 88 and 89, as noted above, Saporito discloses the inclusion of a surfactant in the sustained release injectable neurosteroid formulation. The surfactant may be poloxamers (para.0076).
With regards to Claim 95, the injectable formulation may include polyethylene glycol (PEG) (para.0075, 0098, 0100).
With regards to Claim 98, among the suitable tonicity adjusting agent for inclusion include dextrose, mannitol, and glycerin (par.0089).
With regards to Claims 100 and 101, Saporito appears to be silent to the inclusion of cyclodextrins. Thus, absent evidence to the contrary, Saporito encompasses sustained release injectable formulations that are free of cyclodextrins.
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 51, 84-90, 95, 98, 100, 101, 105, 107 and 108-110 are rejected under 35 U.S.C. 103 as being unpatentable over Saporito et al. (Saporito) (US 2018/0296487 A1; published Oct. 18, 2018).
The teachings of Saporito as they apply to Claims 51, 84-86, 88, 89, 95, 98, 100, 101, and 108-110 are set forth above and incorporated herein. Additional relevant teachings of Saporito are set forth herein below.
With regards to Claim 87, as discussed above, the neurosteroid particles have a D50 (volume weighted median diameter) of less than 10 microns, such as between 1-5 micron. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
With regards to Claim 90, Saporito discloses that the ratio of neurosteroid to surfactant (w:w) Is about 10:1.5 to about 10:01 (para.0151). Saporito also discloses that in an embodiment, the formulation is an aqueous suspension comprising 25 mg/ml to 150 mg/ml neurosteroid (para.0154). Thus, in the case that the formulation is an aqueous suspension comprising 100 mg/ml brexanolone, and is in a ratio of brexanolone to surfactant of 10:1, the formulation would have about 10 mg/ml of surfactant, equating to about 1% w/v surfactant. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
With regards to Claims 105 and 107, the sustained release dosage forms may be “depot” formulations having a release profile in which the neurosteroid reaches a therapeutically effective concentration in plasma soon after injection and remains at an effective plasma concentration of at least 72 hours, 96 hours, 120 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, or 1 month. The plasma levels also remain at all times below a threshold level at which wide effects become unacceptable. The features of plasma levels above a minimal therapeutically effective concentration for an extended period but below the level at which side effects are unacceptable are the criteria of a depot, or sustained release formulation (para.0090).
Thus, with regards to Claims 105 and 107, it would have been obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. In light of Saporito’s disclosure of the criteria for the length of time for maintaining at an effective plasma concentration and necessity of being below a threshold level at which side effects are unacceptable, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine experimentation and adjust parameters of the formulation disclosed by Saporito to arrive at the optimal pharmacological parameters to be within the criteria set forth by Saporito. Where 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, 105 USPQ 233 (CCPA 1955).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the teachings of the prior art reference is fairly suggestive of the claimed invention.
Claims 96, 97, 99, 103, 104, and 106 are rejected under 35 U.S.C. 103 as being unpatentable over Saporito et al. (Saporito) (US 2018/0296487 A1; published Oct. 18, 2018) as applied to Claims 51, 84-90, 95, 98, 100, 101, 105, 107, and 108-110 set forth above, further in view of During (US 2018/0042903 A1; published Feb. 15, 2018).
The teachings of Saporito as they apply to Claims 51, 84-90, 95, 98, 100, 101, 105, 107, and 108-110 are set forth above and incorporated herein.
Saporito does not appear to explicitly disclose (i) wherein the PEG is as recited in Claim 96; (ii) wherein the suspending agent is present in an amount as recited in Claim 97; (iii) wherein the tonicity adjusting agent is present in an amount as recited in Claim 99; (iv) wherein the Cmax is as recited in Claims 103 and 104. During is relied upon for these disclosures. The teachings of During are set forth herein below.
During discloses the use of allosteric modulators for the treatment of epileptic disorders in a subject in need thereof (abstract). The allosteric modulator may be a neurosteroid, such as allopregnanolone (brexanolone), which may be administered parenterally (para.0030, 0037).
During discloses that the parenteral compositions of allosteric modulator includes a stabilizing amount of at least one excipient, such as buffering agents and tonicity agents (para.0090). The excipient may be present at a weight percent (w/v) between about 1 to 10%, or 0.1 to 1% (para.0091).
Among the excipients that may be used include polyethylene glycol, such as PEG 4000 or PEG 6000 (para.0097).
Isotonic pharmaceutical compositions may be achieved by adding an appropriate quantity of sodium chloride. For example, the excipients may include one or more tonicity agents, such as sodium chloride. Tonicity agents may be used to minimize tissue damage and irritation, reduce hemolysis of blood cells, and/or prevent electrolyte imbalance (para.0100).
During discloses methods of treating an epileptic disorder including administering to a patient in need thereof a pharmaceutical composition including an allosteric modulator, wherein the composition provides an in vivo plasma profile having a Cmax less than 500 ng/ml, such as less than about 100 ng/ml, and wherein the composition provides improvement of next day functioning of the patient (para.0069-0070).
During discloses that parenteral solutions including an allosteric modulator and/or gaboxadol may be prepared by mixing the required amount of allosteric modulator and/or gaboxadol in parenteral fluids such as DSW, distilled water, saline, or PEG, and adjusting the pH of the solution between 6.8-8 (para.0108). In an embodiment, single dose administration of the dosage form provides an in vivo plasma profile for gaboxadol encompassing a mean AUC0[Wingdings font/0xE0]∞ of more than about, e.g., 50 ng•hr/ml (para.0110).
With regards to the specific PEG as recited in Claim 96, as discussed above, both Saporito and During are directed to injectable formulations of allopregnanolone (brexanolone) for use in treating epileptic disorders. Saporito further discloses the inclusion of PEG in their formulations. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Saporito and During and try During’s PEG 4000 or PEG 6000 as the PEG component in Saporito’s formulation. One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as both Saporito and During are directed to injectable formulations of allopregnanolone, Saporito disclose the inclusion of PEG in their formulation, and During discloses that PEG 4000 and PEG 6000 are art recognized and conventional specific PEGs for inclusion into injectable formulations of allopregnanolone, particularly for those used in treating epileptic disorders.
With regards to the amount of suspending agent (Claim 97) and amount of tonicity adjusting agent (Claim 99), as discussed above, Saporito discloses that their injectable formulations of allopregnanolone further includes excipients, such as suspending agents and tonicity adjusting agent. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Saporito and During and incorporate each amount of Saporito’s excipients in amounts disclosed by During (about 0.1% to about 10% w/v). One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as both Saporito and During are directed to injectable formulations of allopregnanolone, During discloses that excipients are known to be included into such formulations in amounts ranging from about 0.1% to about 10% w/v.
Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. In particular, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine experimentation to adjust the amounts of each excipient, based on for example, the art disclosed amounts and ranges to optimize the properties of the formulation as needed, e.g., adjusting the tonicity to minimize tissue damage and irritation; ensure uniform dispersion of the active ingredient in the medium. Where 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, 105 USPQ 233 (CCPA 1955).
With regards to the Cmax of the brexanolone are recited in the instant Claims 103 and 104, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Saporito and During and provide an injectable formulation of Saporito that provides an in vivo plasma profile having a Cmax of brexanolone as disclosed in During. One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as both Saporito and During are directed to administering by injection a formulation of brexanolone for treatment of an epileptic disorder, and During discloses that such a Cmax provides improvement of next day functioning of the patient.
With regards to the AUC as recited in the instant Claim 106, it would have been obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. In particular, as During discloses both brexanolone and gaboxadol for use in treatment of epileptic disorders, and During provides a suitable AUC0[Wingdings font/0xE0]∞ of gaboxadol upon injection, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to use the disclosed AUC as a starting point and engage in routine experimentation to identify the optimal or workable range of AUC0[Wingdings font/0xE0]∞ for brexanolone upon injection to treat epileptic disorders. Where 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, 105 USPQ 233 (CCPA 1955).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the teachings of the prior art reference is fairly suggestive of the claimed invention.
Claims 91-94 are rejected under 35 U.S.C. 103 as being unpatentable over Saporito et al. (Saporito) (US 2018/0296487 A1; published Oct. 18, 2018) as applied to Claims 51, 84-90, 95, 98, 100, 101, 105, 107, and 108-110 set forth above, further in view of Salituro et al. (Salituro) (US 2019/0008873 A1; Jan. 10, 2019).
The teachings of Saporito as they apply to Claims 51, 84-90, 95, 98, 100, 101, 105, 107, and 108-110 are set forth above and incorporated herein.
Saporito does not appear to explicitly disclose (i) wherein the buffering agent is present in an amount as claimed in Claim 91, or (ii) wherein the buffering agent comprises a citrate buffering agent (Claims 92-94). Salituro is relied upon for this disclosure. The teachings of Salituro are set forth herein below.
Salituro discloses a pharmaceutically acceptable solution comprising a neuroactive steroid (e.g. allopregnanolone), which is suitable for parenteral administration (abstract; para.0002, 0003). The solution also includes a buffer (abstract; para.0071). The buffer may be a citrate buffer, and the pH is between about 3 to about 8 (para.0025, 0033, 0093, 0106).
Salituro exemplifies a formulation of allopregnanolone with a citrate buffer (e.g., about 0.013% w/v of citric acid monohydrate and 0.128% w/v of sodium citrate dihydrate; total of about 0.141% w/v of buffer).
As discussed above, Saporito discloses an injectable formulation of allopregnanolone (brexanolone). Saporito also discloses the inclusion of a buffer in the formulation. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Saporito and Salituro and use Salituro’s citrate buffer system discussed above (sodium citrate dihydrate and citric acid monohydrate) in the amounts discussed above. One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as both Saporito and Salituro are directed to injectable formulations of allopregnanolone, and Salituro explicitly discloses that a citrate buffer system (e.g., combination of sodium citrate dihydrate and citric acid monohydrate) are known and conventional for such formulations.
Furthermore, with regards to the amount of each component of the buffer system, it is noted that while the specific amount of sodium citrate dihydrate and citric acid monohydrate disclosed and exemplified by Salituro are slightly outside of the ranges recited in the instant claim 94, the claim recites “about” for each end point, thus encompassing amounts slightly above and below the recited end points. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. As discussed above, Salituro discloses that the pH may be between about 3 to about 8. One of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine experimentation and adjust the amounts of each component of the citrate buffer, based on for example, the art disclosed amounts, to arrive at the desired pH of the formulation. Where 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, 105 USPQ 233 (CCPA 1955).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
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 51 and 84-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 12,370,200 B2 (USPN 200) in view of Saporito et al. (Saporito) (US 2018/0296487 A1; published Oct. 18, 2018).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim substantially similar and overlapping methods of treating a neurological condition (e.g., seizure disorder or postpartum depression) in a subject in need thereof by injection of a pharmaceutical composition comprising brexanolone.
The primary difference between the instant claims and the claims of USPN 200 is that the claims of USPN 200 do not appear to explicitly disclose wherein the formulation is an extended-release formulation. Saporito is relied upon for this disclosure. The teachings of Saporito are set forth above and incorporated herein.
Both Saporito and the claims of USPN 200 are directed to the use of brexanolone for the treatment of neurological conditions (e.g., seizure disorder or postpartum depression). One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the claims of USPN 200 with the teachings of Saporito and formulate USPN 200’s brexanolone composition as a sustained release formulation as disclosed by Saporito. One of ordinary skill in the art would have been motivated to do so in order to obtain the advantage of providing a long-acting therapeutic formulation thus reducing the frequency of injection of the drug and improving, for example, patient compliance with the treatment. One of ordinary skill in the art would have had a reasonable expectation of success in doing so both Saporito and the claims of USPN 200 are directed to the use of brexanolone for the treatment of neurological conditions (e.g., seizure disorder or postpartum depression, and Saporito discloses that for such treatments, brexanolone may be formulated as a sustained release formulation.
Conclusion
Claims 51, 76, and 84-110 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616
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