DETAILED ACTION
Claims 1-30 are pending and being examined on the merits in this office 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 .
Priority
The instant application is a DIV of Pat No 12/453,754, and has earliest effective priority to Provisional Appl No 62/853153, filed 5/27/2019.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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 1-30 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.
Independent claims 1 and 13 recite the term "about” that is a relative term, which renders the claims indefinite. This term is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 2-4, 6, 8, 10-12, 14-16, 18, 20, 22-24, and 27 which also recite the term “about”. Clarification is required.
Because claims 2-12 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Because claims 14-30 depend from indefinite claim 13 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Independent claims 1 and 13 recite the term "present in an amount to provide about 26 mg to about 30 mg of a free base equivalent of leuprolide” that is a relative term, which renders the claims indefinite. This term is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not disclose the “amount” of leuprolide that must be in a claimed extended release composition “to provide” about 26-30 mg of a “free base equivalent of leuprolide”. Clarification is required.
Because claims 2-9 and 12 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Because claims 14-21 and 24-30 depend from indefinite claim 13 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 depends from claim 25. Claim 25 recites that kit comprising the dual syringe system of claim 13 and instructions for using the dual syringe system in a recited patient population.
Claim 26 recites wherein the HR+ breast cancer is human epidermal growth factor receptor 2 (HER2)-negative cancer. Claim 26 is deemed to not further limit claim 25. Examiner expressly notes that claim 25 is drawn to a composition- a kit comprising the dual syringe system of claim 13 and instructions.
Claim 26 recites an intended patient population for the kit. This does not further limit the structural inter-physical limitations of the claimed kit composition. Accordingly, claim 26 is not deemed to further limit the subject matter of claim 25.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunn (U.S. 2014/0357574).
Dunn teach an extended release composition comprising a the biodegradable polymer comprising poly(lactic acid/glycolic acid) copolymer segments, the ratio is within a range about 70/30 to about 90/10 (preferably about 75/25), a biocompatible solvent (N-methylpyrrolidone), and leuprolide acetate in an injectate volume of less than 0.5 mL (abstract; paras. [0009], [0064], [0073], Ex 2-4). The biodegradable polymer comprises at least one distal end that is hydroxyl terminated (e.g., paras. [0048], [0058]. Example 4 discloses a controlled release formulation, comprising 30 mg of leuprolide acetate of a flowable composition comprising a polymer of the invention and N-methylpyrrolidone, prepared analogously to Example 2. Example 2 discloses a 75/25 lactide to glycolide weight ratio. Dunn further teaches compositions comprising 0.375 ml (Ex 2, 3, 7).
M.P.E.P. § 2111.02 reads, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” As such, the limitation “for use in suppressing ovarian function during treatment of hormone receptor-positive breast cancer in pre- or peri-menopausal women” does not affect the patentability of the claimed composition/method. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application.
The claimed composition appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989). Accordingly, the limitations of claim 1 are satisfied.
Regarding claim 2, Dunn teach that the extended release compositions are subcutaneously administered. The sustained release of the leuprolide from an implant incorporating a polymer persists as long as about 90 days or about 120 days or about 180 days after implantation. The composition can be used to formulate a three month, a four month, or a six month controlled release delivery system for leuprolide acetate (e.g., abstract, paras. [0070]-[0074], Ex 2). It is further noted that the claim recites an intended use - provide release of a recited leuprolide concentration per month in a claimed patient population - that does not further limit the claimed extended release composition. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application. MPEP § 2111.02. Accordingly, the limitations of claim 2 are satisfied.
Regarding claims 3 and 4, Dunn teach that the polymer has a weight average molecular weight of about 19 kD to about 30 kD, preferably about 21 kD (paras. [0064]-[0065], [0069]). Regarding claim 5, biodegradable polymer is 1,6-hexanediol-initiated (e.g., paras. [0011]-[0013], [0041]-[0042], [0055]-[0072], Ex 5). Regarding claim 6, the biopolymer has a lactide to glycolide molar ratio of about 75:25 (e.g., paras. [0064], Ex 2, claims 1-2). Regarding claim 7, controlled release composition comprises about 35 wt. % to about 60 wt. % of the flowable composition, or 40-50 wt% of the composition (paras. [0021], [0069]). Example 2 discloses the 75/25 PLG polymer and N-methylpyrrolidone were mixed in a 45/55 weight ratio. Regarding claim 8, Dunn teach the biodegradable polymer that the structure of the polymer of the can be expressed as: HO-(PL polymer segment)-C(O)O-alkane-OC(O)-(PL polymer segment)-OH or HO-(PLG copolymer segment)-C(O)O-alkane-OC(O)-(PLG copolymer segment)-OH or HO-(PLGA copolymer segment)-C(O)O-alkane-OC(O)-(PLGA copolymer segment)-OH or HO-(PLA polymer segment —C(O)O-alkane-OC(O)-(PLA polymer segment)-OH. The alkane is an alkanediol core (e.g., paras. [0009]-[0013]], [0041]). Regarding claim 9, Example 2 discloses the 75/25 PLG polymer and N-methylpyrrolidone were mixed in a 45/55 weight ratio (55% NMP). Example 5 discloses 50% NMP. Regarding claims 10 and 11, and extended release composition can comprise 30 mg leuprolide acetate (para. [0073], Ex 4, claims 2, 3, 8, 13, 18). Regarding claim 12, the controlled release formulation in a comedian and injection volume of about 0.375 mL (Exs 2-3, 7).
Regarding claim 13, Dunn teach a dual syringe system wherein the first syringe comprises the biodegradable polymer and NMP, and the second syringe comprises leuprolide acetate (Examples 2, 4, claims 1-3, 5, 8, 10, 13). Example 2 teaches connecting the two syringes with a luer-lock type connector, and exchanging the contents of the syringes. The above information relating to the rejection claim 1 also applies to the rejection of claim 13 and is incorporated herein.
Regarding claim 14, Dunn teach that the extended release compositions are subcutaneously administered. The sustained release of the leuprolide from an implant incorporating a polymer persists as long as about 90 days or about 120 days or about 180 days after implantation. The composition can be used to formulate a three month, a four month, or a six month controlled release delivery system for leuprolide acetate (e.g., abstract, paras. [0070]-[0074], Ex 2). It is further noted that the claim recites an intended use - provide release of a recited leuprolide concentration per month in a claimed patient population - that does not further limit the claimed extended release composition. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application. MPEP § 2111.02. Accordingly, the limitations of claim 2 are satisfied.
Regarding claims 15 and 16, Dunn teach that the polymer has a weight average molecular weight of about 19 kD to about 30 kD, preferably about 21 kD (paras. [0064]-[0065], [0069]). Regarding claim 17, biodegradable polymer is 1,6-hexanediol-initiated (e.g., paras. [0011]-[0013], [0041]-[0042], [0055]-[0072], Ex 5). Regarding claim 18, the biopolymer has a lactide to glycolide molar ratio of about 75:25 (e.g., paras. [0064], Ex 2, claims 1-2). Regarding claim 19, controlled release composition comprises about 35 wt. % to about 60 wt. % of the flowable composition, or 40-50 wt% of the composition (paras. [0021], [0069]). Example 2 discloses the 75/25 PLG polymer and N-methylpyrrolidone were mixed in a 45/55 weight ratio. Regarding claim 20, Dunn teach the biodegradable polymer that the structure of the polymer of the can be expressed as: HO-(PL polymer segment)-C(O)O-alkane-OC(O)-(PL polymer segment)-OH or HO-(PLG copolymer segment)-C(O)O-alkane-OC(O)-(PLG copolymer segment)-OH or HO-(PLGA copolymer segment)-C(O)O-alkane-OC(O)-(PLGA copolymer segment)-OH or HO-(PLA polymer segment —C(O)O-alkane-OC(O)-(PLA polymer segment)-OH. The alkane is an alkanediol core (e.g., paras. [0009]-[0013]], [0041]). Regarding claim 21, Example 2 discloses the 75/25 PLG polymer and N-methylpyrrolidone were mixed in a 45/55 weight ratio (55% NMP). Example 5 discloses 50% NMP. Regarding claims 22 and 23, and extended release composition can comprise 30 mg leuprolide acetate (para. [0073], Ex 4, claims 2, 3, 8, 13, 18). Regarding claim 24, the controlled release formulation in a comedian and injection volume of about 0.375 mL (Exs 2-3, 7).
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
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.
Claim(s) 1-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dunn (U.S. 2014/0357574), and further in view of Dunn et al (U.S. 2016/0106805- cited in IDS filed 10/30/2025; hereinafter referred to as “Dunn 2”).
Dunn teach an extended release composition comprising a the biodegradable polymer comprising poly(lactic acid/glycolic acid) copolymer segments, the ratio is within a range about 70/30 to about 90/10 (preferably about 75/25), a biocompatible solvent (N-methylpyrrolidone), and leuprolide acetate in an injectate volume of less than 0.5 mL (abstract; paras. [0009], [0064], [0073], Ex 2-4). The biodegradable polymer comprises at least one distal end that is hydroxyl terminated (e.g., paras. [0048], [0058]. Example 4 discloses a controlled release formulation, comprising 30 mg of leuprolide acetate of a flowable composition comprising a polymer of the invention and N-methylpyrrolidone, prepared analogously to Example 2. Example 2 discloses a 75/25 lactide to glycolide weight ratio. Dunn further teaches compositions comprising 0.375 ml (Ex 2, 3, 7). Dunn teach a dual syringe system wherein the first syringe comprises the biodegradable polymer and NMP, and the second syringe comprises leuprolide acetate (Examples 2, 4, claims 1-3, 5, 8, 10, 13). Example 2 teaches connecting the two syringes with a luer-lock type connector, and exchanging the contents of the syringes.
Dunn does not expressly teach a kit comprising the dual syringe system.
Dunn 2 teach a flowable composition that is suitable for use as a controlled release implant. The flowable composition includes a biodegradable thermoplastic polyester that is at least substantially insoluble in aqueous medium or body fluid. The flowable composition also includes a biocompatible polar aprotic solvent. The biocompatible polar aprotic solvent is miscible to dispersible in aqueous medium or body fluid. The flowable composition also includes leuprolide acetate (abstract). The biodegradable thermoplastic polymer is preferably 75/25 poly (DL-lactide-co-glycolide); present in about 40 wt. % to about 50 wt. % of the composition; and an average molecular weight of about 15,000 to about 24,000 daltons (para. [0027). The flowable composition is injected into the body of a patient, allowing the biocompatible polar aprotic [organic] solvent to dissipate to produce a solid biodegradable implant [in situ] (e.g., paras. [0012]-[0013], [0024], [0036]-[0038], Ex 1-9). Dunn 2 further teaches the use of the kit comprising instructions for preparation and use of disclosed formulations (Para. [0016]). The kit can comprise a first container (syringe containing polymer and NMP/solvent) and a second container (syringe containing leuprolide acetate). The containers can be configured to be directly connected to each other (paras. [0016], [0036], Ex 4. 6. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a kit comprising the dual syringe system of Dunn comprising a syringe comprising the biodegradable polymer (PLG, having a lactide to glycolide ratio of 75:25) and NMP, and a second syringe comprising a leuprolide (30 mg), in an injection amount of less than 0.5 ml. Dunn expressly taught the claimed extended release compositions, dual syringes, and subcutaneous/intramuscular administration for in situ formation of a depot for the controlled release of leuprolide in a subject (abstract; paras. [0009], [0048], [0058], [0064], [0068]-[0074], Ex 2-4, 7). Dunn 2 taught kits comprising dual syringes for preparing the controlled release implants/depots and instructions for use. The skilled artisan would have had a reasonable expectation of success because the prior art taught controlled release implants comprising leuprolide acetate, NMP, and PLG (75:25 ratio), and dual syringes for preparing the claimed compositions to provide controlled delivery of leuprolide acetate.
M.P.E.P. § 2111.02 reads, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” As such, the limitation “for use in suppressing ovarian function during treatment of hormone receptor-positive breast cancer in pre- or peri-menopausal women” does not affect the patentability of the claimed composition/method. Compositions are defined by their physical, structural, and chemical properties, not by an intended use or application.
The claimed composition appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
M.P.E.P. § 2112.01 recites, “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Accordingly, the limitations of claim 25 are satisfied.
Regarding claim 26, the claim recites an intended use -patient population- for the claimed kit.
Regarding claims 27-29, M.P.E.P. § 2112.01 recites, “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Regarding claims 30, Dunn teaches that the composition forms a biodegradable or bioerodible microporous implant formed in situ in animals (paras. [0047], [0068]-[0074], Exs 2-4). The organic solvent (e.g., NMP) dissolves the polymer (PLG) and the medicament (leuprolide). When a flowable composition comprising the controlled release formulation is emplaced within a tissue of a patient in need thereof, the polymer coagulates from solution as the organic solvent diffuses away into the surrounding aqueous body fluids. This coagulated composition then slowly releases the medicament over a period of time (e.g., para [0020], [0068]-[0069]). Examples 2-4 teach preparation of controlled release formulations that were subcutaneously administered and formed depots [reads on in situ solid or semisolid depot]. The claimed composition appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Accordingly, claims 1-30 are obvious in view of the teachings of the cited references.
Relevant Art Not Relied Upon
Downing et al (WO 2017/024027) teach liquid polymer pharmaceutical compositions with a biodegradable liquid polyester that has a carboxylic acid end group, a biocompatible solvent (NMP), and an active pharmaceutical agent (leuprolide acetate) are useful for administration into the body to provide extended long term release of the drug (abstract; pp. 3, 16, 21-22). Leuprolide amounts include 3.75 mg, 7.5 mg, 11.25 mg, 22.5 mg, 30 mg, and 45 mg (p. 22). The compositions can be administered by parenteral route, such as subcutaneous, intramuscular, and intradermal routes (pp. 18 and 22).
Ravivarapu et al (AAPS PharmSciTech J. 1(1):page e1 (2000)- cited in IDS filed 10/30/2025). Ravivarapu et al teach compositions comprising 75/25 poly (DL-lactide-co-glycolide) in N-methyl-2 pyrrolidone [organic solvent], and leuprolide at 3%, 4.5%, or 6% (abstract, pp. 2-5).
Ravivarapu et al (J. Pharma Sci 89(6): 732-741 (2000)- cited in IDS filed 10/30/2025- hereinafter referred to as “Ravivarapu 2”). Ravivarapu 2 teaches compositions comprising formulations with biodegradable lactide/glycolide copolymers that varied in molecular weight, lactide/glycolide ratio. a formulation containing a 75/25 lactide/glycolide copolymer dissolved in N‐methyl‐2‐pyrrolidone with 3% w/w leuprolide acetate was assessed. This formulation with its advantages of biodegradability, biocompatibility, ease of injection, and no need for removal after use should be beneficial in treating patients with hormonal‐dependent prostate and mammary cancers, endometriosis, and precocious puberty. In addition, this formulation with its simple manufacturing process is expected to provide an economic benefit to the user compared with products currently available on the market (abstract).
Dunn (U.S. 8840916 - cited in IDS filed 10/30/2025) teach a polymer comprising poly(lactide), poly(lactide/glycolide) or poly(lactic acid/glycolic acid) segments bonded by ester linkages to both ends of an alkanediol core unit. The polymer is for use in a controlled release formulation for a medicament, preferably leuprolide acetate. The controlled release formulation is administered to a patient as a subcutaneous depot of a flowable composition comprising the polymer, a biocompatible solvent, and the medicament. Controlled release formulations comprising the polymer release leuprolide for treatment of patients over periods of 3-6 months (abstract). The polymer can comprise a polymer of Formula (I/II):
PNG
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219
892
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Greyscale
wherein L/G signifies a PLG copolymer segment, the H atoms at both distal ends signify the hydrogen atoms borne by the terminal hydroxyl groups, and Ra is an alkylene diradical; Rb and Rc are either hydrogen or methyl; the polymer is substantially insoluble in water and body fluid, the polymer has substantially no titratable carboxylic acid groups, the polymer has a weight average molecular weight from about 10 kD to about 50 kD, and the polymer in neat form is a solid at ambient temperature (claim 1). The ratio of lactide to glycolide in the PLG copolymer segment is within a range of about 45/55 to about 99/1. Preferably, the ratio is within a range of about 70/30 to about 90/10. In a specific example, the ratio is about 75/25. In another specific example the ratio is 85/15 (col 13). Organic solvents include N-methylpyrrolidone, N,N-dimethylformamide, and N,N-dimethylacetamide (col. 5). “Alkanediol” as used herein refers to a saturated, branched or straight chain or cyclic alkane diradical of about 4 to about 8 carbon atoms, having two monovalent radical centers derived by the removal of two hydrogen atoms from different carbon atoms of the parent alkane, wherein each monovalent radical center bears a hydroxyl group. Thus, an alkanediol is a dihydroxyalkane. Alkane diradicals include, but are not limited to: 1,4-butylene(-CH2CH2CH2CH2—), 2,3-butylene(CH3ĊHĊHCH3), 1,6-hexylene(-CH2CH2CH2CH2CH2CH2—), 1,4-cyclohexanedimethyl(-CH2-cyclohexyl-CH2—), and the like. Typical alkanediols of the invention therefore include, but are not limited to, 1,4-butanediol(HOCH2CH2CH2CH2OH), 2,3-butanediol(CH3CH(OH)CH(OH)CH3), 1,6-hexanediol(HOCH2CH2CH2CH2CH2CH2OH), cyclohexane-1,4-dimethanol, and the like (e.g., col. 8).
Schmid et al (J Clin Oncol 25: 2509-2515 (2007)- cited in IDS filed 10/30/2025) teach that ovarian suppression with luteinizing hormone-releasing hormone (LHRH) agonists, e.g. leuprolide acetate, is an effective adjuvant treatment in premenopausal patients with hormone receptor-positive, node-positive breast cancer (abstract). Patients were administered a 3 month subcutaneous depot comprising 11.25 mg leuprolide acetate (p. 2510). Luteinizing hormone levels decreased in patients (e.g., p. 2512).
Dadey et al (U.S. 20160106847- cited in IDS filed 10/30/2025) teach a PLG copolymer material, termed a PLG(p) copolymer material, adapted for use in a controlled release formulation for a bioactive material is provided, wherein the formulation exhibits a reduced “initial burst” effect when introduced into the tissue of a patient in need thereof (abstract). Dadey et al teach a controlled release formulation comprising a flowable delivery system comprising: an organic solvent, a bioactive agent and a biocompatible, biodegradable, non-hydrolyzed PLG low-burst copolymer material having a weight average molecular weight of about 15 kilodaltons to about 50 kilodaltons and a polydispersity index of about 1.4 to about 1.8 and which low-burst copolymer material is substantially free of a copolymer fraction characterized by a weight average molecular weight of about 4 kDa to about 10 kDa and a polydispersity index of about 1.4 to 2.5 (claim 41). bioactive agents include leuprolide (e.g., paras. [0052]-[0054], claims 45-40). Organic solvents include N-methylpyrrolidone, N,N-dimethylformamide, N,N-dimethylacetamide, dimethylsulfoxide, polyethylene glycol 200, polyethylene glycol 300, or methoxypolyethylene glycol 350 (e.g., claim 47). The flowable extended release compositions can be used to treat breast cancer (para. [0052]).
Li et al (U.S. 2016/0331802- cited in IDS filed 10/30/2025) teach stabilized biodegradable polymeric composition useful as a controlled release delivery system for peptide agents. The compositions comprise a) a beneficial salt of a peptide agent that minimizes or prevents the interaction/reaction between the peptide agent and the polymer in an organic solution; b) a biodegradable polymer; c) a pharmaceutically acceptable organic solvent. The reference teaches an injectable polymeric composition comprising a leuprolide salt, b) a biodegradable polymer selected from the group of polylactide, poly(lactic acid), poly(lactic acid-co-glycolic acid), and poly(lactide-co-glycolide); and c) N-methyl-2-pyrrolidone (NMP). Peptides salts include leuprolide acetate (para. [0045]). For example, leuprolide acetate is dissolved in a suitable liquid medium, e.g., water. This solution of the peptide agent is mixed with an aqueous solution of a strong acid such as hydrochloric acid. When the peptide acetate and a strong acid such as hydrochloric acid are dissolved in water, the peptide tends to be associated with chloride ion, as the stronger acid HCl displaces the weaker carboxylic acetic acid. The solvent and liberated acetic acid (or other weak but volatile carboxylic acid) may be removed under vacuum. Id. See also Ex 1-3, 8-14, and 17.
Li et al do not explicitly teach the recited molar ratio of lactide to glycolide monomers, or amount of leuprolide in the claimed composition.
Conclusion
No claims are allowed.
Claims 1-30 are pending and rejected.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654