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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-6, 8-13 and 15-19) drawn to a storage stable sustained release therapeutic formulation, is acknowledged. Within the elected group I, Applicants’ election for the species of benzodiazepine as the therapeutic agent) (claims 1-2, 4-6, 8-10, 13, 15-19), is acknowledged. It is noted that Applicants also elected injection as the route of administration and anxiety, muscle spasms and seizures as the disease (claims 32-35, 38, 32-34, 37-38, 40-42, 44-46, 49 and 51-55), both of which will be withdrawn as they pertain to the non-elected invention (i.e., they are not part of group I). The elections were made without traverse.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 3, 11-12, 21-26, 28-42, 44-49 and 51-55 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, and non-elected species of the invention, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention, and the elected species of the invention. Applicants timely responded to the restriction/election requirement in the reply filed 3/4/26.
Accordingly, claims 1-2, 4-6, 8-10, 13 and 15-19 are under current examination.
Status of Claims
A new claim set was filed on 1/23/24 with the following:
Amended claims
6, 8, 13, 15, 17-19, 26, 42, 44, 49, 51 and 55
Newly canceled claims
7, 14, 20, 27, 43, 50 and 56
Newly added claims
Previously canceled claims
Instantly withdrawn claims
3, 11-12, 21-26, 28-42, 44-49 and 51-55
Claims under instant examination
1-2, 4-6, 8-10, 13 and 15-19
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 6 and 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-4 are unclear as claims 2-3 recite the limitation "the therapeutic agent". There is insufficient antecedent basis for this limitation in the claim. Claim 2 depends from claim 1 and claim 3 depends from claims 1 and 2. Claim 1 recites “at least one therapeutic agent” which encompasses multiple therapeutic agents (emphasis added). Thus, it is unclear whether just one, more than one, or all of the therapeutic agents are being referenced and must be selected from the recited species within the Markush grouping. Amending claims 2-3 to recite “wherein the at least one therapeutic agent is…”, would overcome this rejection.
Claims 6 and 8-10 are unclear as claim 6 recites the limitation "the ionization stabilizing excipient". There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 1, which recites “at least one ionization stabilizing excipient” which encompasses multiple ionization stabilizing excipients (emphasis added). Thus, it is unclear whether just one, more than one, or all of the ionization stabilizing excipients are being referenced and must be selected from the recited species within the Markush grouping. Amending claim 6 to recite “wherein the at least one therapeutic agent is…”, would overcome this rejection.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefinite concerns outlined above.
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 1, 5-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donovan et al. (US 2020/0376083; published: 12/3/20; in IDS dated 5/1/24).
Donovan is directed to stable therapeutic compositions in aprotic polar solvents (Title).
With regards to instant claims 1 and 5, Donovan teaches a formulation comprising one or more therapeutic agents (having limited aqueous solubility) dissolved in an aprotic polar solvent system, such as DMSO/water admixture, and comprising at least one ionization stabilizing excipient (Abstract, [0023], [0027]). Stable solutions of a therapeutic agent(s) solubilized in non-aqueous aprotic polar solvents (e.g., DMSO) can be prepared by adding a specific amount of a compound, or combination of compounds that function as an ionization stabilizing excipient ([0025]). With respect to the stability limitations of instant claim 1, since the formulation of Donovan comprises the same compounds at the same concentrations, the composition taught by Donovan must necessarily be capable of remaining stable for at least 6 months at 2 °C to 8 °C. It is noted that Donovan teaches chemical stability for at least 3 months at a higher temperature (25 C) [0043].
With regards to “the presence of therapeutic levels…for an extended period of time” limitation of instant claim 1, Donovan teaches an embodiment, wherein the therapeutic agent is administered by infusion over time; e.g., over at least 24 hours or over a period of multiple days [0012].
With regards to instant claims 6 and 8, Donovan teaches wherein the ionization stabilizing agent may be a suitable mineral acid such as sulfuric acid [0026].
Therefore, by teaching all the limitations of claims 1, 5-6 and 8, Donovan anticipates the instant invention as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan et al. (US 2020/0376083; published: 12/3/20; in IDS dated 5/1/24).
As noted in the anticipation rejection above Donovan anticipates claims 1, 5-6 and 8 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Donovan for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Donovan is directed to stable therapeutic compositions in aprotic polar solvents (Title).
With regards to instant claims 1 and 5, Donovan teaches a formulation comprising one or more therapeutic agents (having limited aqueous solubility) dissolved in an aprotic polar solvent system, such as DMSO/water admixture, and comprising at least one ionization stabilizing excipient (Abstract, [0023], [0027]). Stable solutions of a therapeutic agent(s) solubilized in non-aqueous aprotic polar solvents (e.g., DMSO) can be prepared by adding a specific amount of a compound, or combination of compounds that function as an ionization stabilizing excipient ([0025]). With regards to “the presence of therapeutic levels…for an extended period of time” limitation of instant claim 1, Donovan teaches an embodiment, wherein the therapeutic agent is administered by infusion over time; e.g., over at least 24 hours or over a period of multiple days [0012].
With regards to instant claims 6 and 8, Donovan teaches wherein the ionization stabilizing agent may be a suitable mineral acid such as sulfuric acid [0026].
With regards to instant claims 9-10, Donovan teaches that the ionization stabilizing excipient (e.g., sulfuric acid) is at a concentration of 0.01 mM to less than 200 mM ([0013]) or more specifically, about 4 mM to about 9 mM (claim 34). Donovan teaches that concentration of the therapeutic agent and/or ionization stabilizing excipient added to the solution can be between 0.01, 0.1, 1, 10, 100, 1000 mM, or up to its solubility limit, including all values and ranges there between ([0027]).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Donovan teaches wherein the therapeutic agent and/or ionization stabilizing excipient added to the solution can be between 0.01, 0.1, 1, 10, 100, 1000 mM, or up to its solubility limit, including all values and ranges there between ([0027]), Donovan does not specifically teach wherein said mineral acid (i.e., the ionization stabilizing excipient) is present in said formulation at a molar concentration ratio of between 2:1 and 3:1 (or about 2.5:1) relative to the concentration of said therapeutic agent in said formulation, as required by instant claims 9-10.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding the molar concentration of the ionization stabilizing excipient (e.g., mineral acid) and the therapeutic agent as specified in claims 9-10, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is 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).
Furthermore, Donovan teaches that the ionization stabilizing excipient (e.g., sulfuric acid) is at a concentration of 0.01 mM to less than 200 mM ([0013]) or more specifically, about 4 mM to about 9 mM (claim 34). Donovan teaches that concentration of the therapeutic agent and/or ionization stabilizing excipient added to the solution can be between 0.01, 0.1, 1, 10, 100, 1000 mM, or up to its solubility limit, including all values and ranges there between ([0027]). Furthermore, Donovan teaches that the ionization stabilizing excipient can be added in an amount to stabilize the ionization of the therapeutic agent ([0013]). Donovan teaches that the dosage administered will, of course, vary depending upon known factors, such as the pharmaco-dynamic characteristics of the particular compound, salt, or combination; the age, health, or weight of the subject; the nature and extent of symptoms; the metabolic characteristics of the drug and patient, the kind of concurrent treatment; the frequency of treatment; or the effect desired (0028]). The Applicants' specification provides no evidence that the selected molar concentration ratio range in claims 9-10 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous physical/chemical properties of various chemicals (e.g., the age, health, or weight of the subject; the nature and extent of symptoms; etc.), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine these teachings and alter the molar concentration. One of ordinary skill in the art would have been motivated to change the molar concentration as this could be expected to be advantageous for altering the ionization of the therapeutic agent and/or altering the therapeutic outcome.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan et al. (US 2020/0376083; published: 12/3/20; in IDS dated 5/1/24) as applied to claims 1, 5-6 and 8-10 above, and further in view of Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24).
As noted in the anticipation rejection above Donovan anticipates claims 1, 5-6 and 8 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Donovan for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Donovan is directed to stable therapeutic compositions in aprotic polar solvents (Title).
See the above rejections for Donovan’s teachings that read on instant claims 1, 5-6 and 8-10.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Donovan teaches non-limiting examples of small molecule drugs that can be used in the context of the present invention including benzodiazepines, Donovan does not teach an embodiment wherein the therapeutic agent is a benzodiazepine and more specifically, diazepam, as required by instant claims 2 and 4. However, this deficiency is cured by Prestrelski.
Prestrelski is also directed to stable therapeutic compositions in aprotic polar solvents (Title).
Prestrelski teaches a stable formulation comprising: (a) a therapeutic glatiramer or pramlintide peptide, wherein the peptide is not prepared by drying in the presence of a non-volatile buffer; (b) an ionization stabilizing excipient, wherein the ionization stabilizing excipient is an acid; and (c) an aprotic polar solvent; wherein (i) the therapeutic peptide is dissolved in the aprotic solvent in an amount from about 0.1 mg/mL up to the solubility limit of the therapeutic peptide, and (ii) the ionization stabilizing excipient is dissolved in the aprotic polar solvent in an amount to stabilize the ionization of the therapeutic peptide (claim 1), wherein the ionization stabilizing excipient is a mineral acid and the aprotic polar solvent is DMSO, which is identical to the formulation taught by Donovan. Prestrelski teaches that the small molecule drug diazepam exhibits extremely low solubility in water at neutral pH (<2 mg/mL). To enhance the solubility of diazepam the pH of the aqueous solution is made acidic or alkaline, which in turn increases the rate of hydrolysis and degradation. In contrast, diazepam is very soluble in the aprotic polar solvents dimethyl sulfoxide (DMSO) and n-methyl pyrrolidone (NMP), with a solubility at least an order of magnitude greater in DMSO and NMP relative to neutral water (>50 mg/mL). Additionally, in the absence of formulation excipients, the diazepam molecule is stable in DMSO and NMP, exhibiting stability for at least 6 months in the aprotic polar solvents under accelerated storage conditions (40° C., 75% RH) (2nd para. of Part B. Description of Related Art). Furthermore, Prestrelski teaches that the small molecule drugs that can be used in the present invention includes benzodiazepines.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Donovan and Prestrelski are both directed to formulations comprising a therapeutic agent, aprotic polar solvent (e.g., DMSO) and ionization stabilizing excipient (e.g., mineral acid). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the formulation of Donovan by incorporating diazepam to achieve the predictable result of obtaining a composition suitable for enhancing the solubility and stability of a diazepam-containing formulation. One of ordinary skill in the art would have been motivated to do so because Prestrelski teach that it would be advantageous for a drug like diazepam that exhibits extremely low solubility in water at neutral pH (<2 mg/mL) to enhance the solubility and stability of diazepam by solubilizing in the aprotic polar solvents dimethyl sulfoxide (DMSO) (2nd para. of Part B. Description of Related Art).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 13 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan et al. (US 2020/0376083; published: 12/3/20; in IDS dated 5/1/24) as applied to claims 1, 5-6 and 8-10 above, and further in view of Pathak (WO 2014/160387; published: 10/2/14).
As noted in the anticipation rejection above Donovan anticipates claims 1, 5-6 and 8 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Donovan for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Donovan is directed to stable therapeutic compositions in aprotic polar solvents (Title).
See the above rejections for Donovan’s teachings that read on instant claims 1, 5-6 and 8-10.
With regards to instant claims 13 and 15-18, Donovan teaches Formulation 1 which comprises: 5 mg/mL glucagon, 5.53% (w/v) trehalose DH, 2.9% (w/v) mannitol, 3.2 mM H2SO4 and DMSO (i.e., the claimed therapeutic agent, sugar, sugar alcohol, ionization stabilizing excipient (mineral acid) and aprotic polar solvent system) [Table 3]. Additionally, Donovan teaches that the formulation can further include a preservative; specifically, wherein the preservative is benzyl alcohol [0014].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Donovan does not teach wherein the formulation further comprises a polymer and specifically wherein the polymer is an ester- or acid-terminated PLGA, as required by instant claims 13 and 19. However, this deficiency is cured by Pathak.
Pathak is directed to compositions, methods and devices for local drug delivery (Title). Pathak teaches a PLGA, an exemplary biodegradable polymer that is water insoluble, is used as a carrier for the drugs (Section VI). Removal of water from the infused liquid droplets form PLGA microparticles in situ; the drug remains entrapped in the polymer particle and upon biodegradation of the polymer, the drug is released (Section VI). Pathak exemplifies with the following composition: PLGA dissolved in DMSO solvent and comprising rifampin as an exemplary drug (Section VI). Similar to Donovan Pathak teaches that the formulation is injectable and that the drug is water-insoluble.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Donovan and Pathak are both directed to injectable formulations comprising a therapeutic agent (e.g., water-insoluble drug) and aprotic polar solvent (e.g., DMSO). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the formulation of Donovan by further incorporating PLGA to achieve the predictable result of obtaining a composition suitable for controlled drug release via PLGA degradation and diffusion. One of ordinary skill in the art would have been motivated to do so because Pathak teach that it would be advantageous for a water-insoluble drug to be injected into the body and form a PLGA microparticle in situ, wherein over time, the PLGA biodegradation provides controlled release of said drug (Section VI).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2, 4-6, 8-10 and 13-19 directed to an invention not patentably distinct from claims 1-6 of commonly assigned US Patent No. 12,514,837.
Specifically, claims 1-2, 4-6, 8-10 and 13-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of US Patent No. 12,514,837, in view of Pathak (WO 2014/160387; published: 10/2/14) and Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a therapeutic agent, an ionization stabilizing excipient (e.g., mineral acid such as sulfuric acid), an aprotic polar solvent (e.g., DMSO), trehalose, mannitol and benzyl alcohol. It is noted that the ‘837 composition/product represents a species (with regards to additional features: therapeutic agent concentration and species, ionization stabilizing excipient concentration, trehalose concentration, mannitol concentration and stability characteristics) within the scope of the instantly claimed genus. With regards to instant claims 13 and 15-19, ‘837 composition does not contain PLGA; however, such would be obvious to further incorporate based on the teachings of Pathak. One of ordinary skill in the art would have been motivated to further incorporate PLGA in the composition of ‘837 because Pathak teach that it would be advantageous for a water-insoluble drug to be injected into the body and form a PLGA microparticle in situ, wherein over time, the PLGA biodegradation provides controlled release of said drug (Section VI). With regards to the difference in therapeutic agent (levothyroxine in ‘837 claims and diazepam in instant claim 4), Prestrelski teach that it would be advantageous for a drug like diazepam that exhibits extremely low solubility in water at neutral pH (<2 mg/mL) to enhance the solubility and stability of diazepam by solubilizing in the aprotic polar solvents dimethyl sulfoxide (DMSO) (2nd para. of Part B. Description of Related Art). Therefore, it would have been obvious to substitute the therapeutic agent with diazepam for the above taught advantages. Thus, the instant claims and the application claims are obvious variants.
Claims 1-2, 4-6, 8-10 and 13-19 directed to an invention not patentably distinct from claims 1-22 of commonly assigned US Patent No. 11,964,003.
Specifically, claims 1-2, 4-6, 8-10 and 13-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-22 of US Patent No. 11,964,003, in view of Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a therapeutic agent, an ionization stabilizing excipient (e.g., mineral acid such as sulfuric acid), an aprotic polar solvent (e.g., DMSO), PLGA (acid- or ester-terminated), trehalose dihydrate, mannitol and benzyl alcohol. It is noted that the ‘003 composition/product represents a species (with regards to additional features: at least one sustained release modifier (e.g., zinc sulfate), trehalose concentration, mannitol concentration and stability characteristics) within the scope of the instantly claimed genus. With regards to the difference in therapeutic agent (glucagon in ‘003 claims and diazepam in instant claim 4), Prestrelski teach that it would be advantageous for a drug like diazepam that exhibits extremely low solubility in water at neutral pH (<2 mg/mL) to enhance the solubility and stability of diazepam by solubilizing in the aprotic polar solvents dimethyl sulfoxide (DMSO) (2nd para. of Part B. Description of Related Art). Therefore, it would have been obvious to substitute the therapeutic agent with diazepam for the above taught advantages. Thus, the instant claims and the application claims are obvious variants.
Claims 1-2, 4-6, 8-10 and 13-19 directed to an invention not patentably distinct from claims 1-19 of commonly assigned US Patent No. 11,576,951.
Specifically, claims 1-2, 4-6, 8-10 and 13-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent No. 11,576,951, in view of Pathak (WO 2014/160387; published: 10/2/14) and Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a therapeutic agent, an ionization stabilizing excipient (e.g., mineral acid such as sulfuric acid), an aprotic polar solvent (e.g., DMSO), trehalose and preservative. It is noted that the ‘951 composition/product represents a species (with regards to additional features: moisture content, compatibility with device flow path, therapeutic agent concentration and species, ionization stabilizing excipient concentration, preservative concentration and freezing point) within the scope of the instantly claimed genus. With regards to instant claims 13 and 15-19, ‘951 composition does not contain PLGA; however, such would be obvious to further incorporate based on the teachings of Pathak. One of ordinary skill in the art would have been motivated to further incorporate PLGA in the composition of ‘951 because Pathak teach that it would be advantageous for a water-insoluble drug to be injected into the body and form a PLGA microparticle in situ, wherein over time, the PLGA biodegradation provides controlled release of said drug (Section VI). With regards to the difference in therapeutic agent (glucagon in ‘951 claims and diazepam in instant claim 4), Prestrelski teach that it would be advantageous for a drug like diazepam that exhibits extremely low solubility in water at neutral pH (<2 mg/mL) to enhance the solubility and stability of diazepam by solubilizing in the aprotic polar solvents dimethyl sulfoxide (DMSO) (2nd para. of Part B. Description of Related Art). Therefore, it would have been obvious to substitute the therapeutic agent with diazepam for the above taught advantages. Thus, the instant claims and the application claims are obvious variants.
Claims 1-2, 4-6, 8-10 and 13-19 directed to an invention not patentably distinct from claims 1-4 of commonly assigned US Patent No. 11,590,205.
Specifically, claims 1-2, 4-6, 8-10 and 13-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US Patent No. 11,590,205, in view of Pathak (WO 2014/160387; published: 10/2/14) and Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a therapeutic agent, an ionization stabilizing excipient (e.g., mineral acid such as sulfuric acid), an aprotic polar solvent (e.g., DMSO), trehalose and benzyl alcohol preservative. It is noted that the ‘205 composition/product represents a species (with regards to additional features: therapeutic agent concentration and species, ionization stabilizing excipient concentration, moisture content, preservative concentration) within the scope of the instantly claimed genus. With regards to instant claims 13 and 15-19, ‘205 composition does not contain PLGA; however, such would be obvious to further incorporate based on the teachings of Pathak. One of ordinary skill in the art would have been motivated to further incorporate PLGA in the composition of ‘205 because Pathak teach that it would be advantageous for a water-insoluble drug to be injected into the body and form a PLGA microparticle in situ, wherein over time, the PLGA biodegradation provides controlled release of said drug (Section VI). With regards to the difference in therapeutic agent (glucagon in ‘205 claims and diazepam in instant claim 4), Prestrelski teach that it would be advantageous for a drug like diazepam that exhibits extremely low solubility in water at neutral pH (<2 mg/mL) to enhance the solubility and stability of diazepam by solubilizing in the aprotic polar solvents dimethyl sulfoxide (DMSO) (2nd para. of Part B. Description of Related Art). Therefore, it would have been obvious to substitute the therapeutic agent with diazepam for the above taught advantages. Thus, the instant claims and the application claims are obvious variants.
Claims 1-2, 4-6, 8-10 and 13-19 directed to an invention not patentably distinct from claims 1-4 of commonly assigned US Patent No. 9,649,364.
Specifically, claims 1-2, 4-6, 8-10 and 13-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US Patent No. 9,649,364, in view of Pathak (WO 2014/160387; published: 10/2/14) and Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a therapeutic agent, an ionization stabilizing excipient (e.g., mineral acid), an aprotic polar solvent (e.g., DMSO), trehalose and benzyl alcohol preservative. It is noted that the ‘205 composition/product represents a species (with regards to additional features: DMSO that is deoxygenated, moisture content, therapeutic agent concentration and species, DMSO concentration, ionization stabilizing excipient concentration, moisture content, preservative concentration and trehalose concentration) within the scope of the instantly claimed genus. With regards to instant claims 13 and 15-19, ‘364 composition does not contain PLGA; however, such would be obvious to further incorporate based on the teachings of Pathak. One of ordinary skill in the art would have been motivated to further incorporate PLGA in the composition of ‘205 because Pathak teach that it would be advantageous for a water-insoluble drug to be injected into the body and form a PLGA microparticle in situ, wherein over time, the PLGA biodegradation provides controlled release of said drug (Section VI). With regards to the difference in therapeutic agent (glucagon in ‘364 claims and diazepam in instant claim 4), Prestrelski teach that it would be advantageous for a drug like diazepam that exhibits extremely low solubility in water at neutral pH (<2 mg/mL) to enhance the solubility and stability of diazepam by solubilizing in the aprotic polar solvents dimethyl sulfoxide (DMSO) (2nd para. of Part B. Description of Related Art). Therefore, it would have been obvious to substitute the therapeutic agent with diazepam for the above taught advantages. Thus, the instant claims and the application claims are obvious variants.
Claims 1-2, 4-6, 8-10 and 13-19 directed to an invention not patentably distinct from claims 1-2, 4, 6-10 and 12-17 of commonly assigned US Patent Application No. 18/490,218.
Specifically, claims 1-2, 4-6, 8-10 and 13-19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-2, 4, 6-10 and 12-17 of US Patent Application No. 18/490,218, in view of Prestrelski et al. (US 10,485,850; published: 11/26/19; in IDS dated 5/1/24). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising a therapeutic agent, an ionization stabilizing excipient (e.g., mineral acid such as sulfuric acid), an aprotic polar solvent (e.g., DMSO), PLGA (acid- or ester-terminated), trehalose dihydrate, mannitol and benzyl alcohol. It is noted that the ‘003 composition/product represents a species (with regards to additional features: sulfuric acid concentration, therapeutic agent concentration and stability characteristics) within the scope of the instantly claimed genus. Thus, the instant claims and the application claims are obvious variants.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned US Patent Nos. 12,514,837; 11,964,003; 11,576,951; 11,590,205; 9,649,364 and US Patent Application No. 18/490,218, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617
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