DETAILED ACTION
Status of the Claims
Claims 27-40 are pending in the instant application. Claims 35, 36, 38 and 40 have been withdrawn based upon Restriction/Election as discussed below. Claims 27-34, 37 and 39 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The U.S. effective filing date has been determined to be 05/12/2020, the filing date of PCT/ES2020/070360.
Claim Objections
Claims 27 is objected to because the claim depend from a subsequent claim (claim X). 37 C.F.R. 1.75 makes clear that the claims include: “(c) One or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application.” (MPEP 608.01(i)).
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 29-32, 34, 37 and 39 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 pre-AIA the applicant regards as the invention.
Claims 29-31 each recite in the preamble of the claim “The purified polymer”, however, Applicant has amended the preamble in the base claim to recite “A purified powdered biodegradable thermoplastic polymer […]” which is also recited in amended claim 27. There is insufficient antecedent basis for the limitation “The purified polymer” in claims 29-31.
Claims 32 and 37 recites “purified polymer” in line 2 of each claim, and claims 34 and 39 recites “the purified polymer” in line 1 of each claim. Applicant has amended the preamble in the base claim to recite “A purified powdered biodegradable thermoplastic polymer […]” which is also recited in amended claim 27. There is insufficient antecedent basis for the limitation “The purified polymer” in claims 32, 34, 37 and 39.
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 27-34, 37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by CLAY (US 2014/0296449; published October, 2014).
Applicant Claims
A purified powdered biodegradable thermoplastic polymer free from visible extrinsic particles of a size greater than 150 μm, wherein the biodegradable thermoplastic polymer is selected from the group consisting of PLGA or PLA (instant claim 28).
Applicant further claims the purified powdered biodegradable thermoplastic polymer of claim 28, wherein the polymer is made according to a process comprising the steps of (a) providing powdered biodegradable thermoplastic polymer comprising extrinsic particles; (b) heating said powdered polymer to a temperature that is not more than about 5.5 °C above its melting temperature (Tm) to form molten polymer; (c) filtering the molten polymer through at least one filter having a pore size of about 5-300 μm; (d) cooling the extruded polymer by means of a sterile gas stream to a temperature at least 4.5 to 5.5 °C below the glass transition temperature (Tg) of the biodegradable thermoplastic polymer; and (e) comminuting the cooled polymer to form purified powdered biodegradable thermoplastic polymer (instant claim 27).
With regard to the process steps of claims 27, 29-30, “Even though product-by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113.
Claim interpretation: The instant Specification discloses that: “Extrinsic particles" according to the present invention, means visible particulate systems of a different nature than the starting polymeric materials, which are detectable when such polymeric materials are subjected to dissolution in a medium in which they are completely solubilized. That is, those particulate systems insoluble in a medium in which the starting polymeric material is totally soluble. This definition shall include any amorphous or defined particle of polymeric origin, such as fibers, granules, pellets, agglomerates, aggregates, among others. They may be organic or inorganic in composition. (p. 15, [0066]).
Elected Species: Applicants have elected the following species in the reply filed 07/01/2025: (a) a species of biodegradable thermoplastic polymer is PLGA. The examiner notes that PLGA is a copolymer of glycolic acid (PGA) and lactic acid (PLA) therefore these species will be included in the search.
Disclosure of the Prior Art
CLAY discloses “Methods are provided for preparing polymer mixtures having low residual monomer content. The methods comprise mixing the at least two polymers in a solvent to form a polymeric mixture, the polymeric mixture comprising at least one residual monomer; and adding an antisolvent to the polymeric mixture so as to separate the at least two polymers from the polymeric mixture, where the residual monomer is soluble in the antisolvent. In some embodiments, methods are provided for preparing at least two polymers having low residual monomer content, the methods comprise adding an antisolvent to a mixture of at least two polymers dissolved in a solvent so as to precipitate the at least two polymers from the solvent and anti-solvent. The methods provided avoid steps in dry blending of polymers and produces polymer blends that have low residual monomer content.” (abstract, see whole document).
CLAY discloses biodegradable polymers including PGA, PLA and PLGA ([0027])(instant claim 31). And that: “Biodegradable polymers useful in the preparation of drug depots can be easily hot melt extrudable. In order to produce hot melt extrudable polymers many processes include three unit operations, (i) milling or grinding to reduce polymer particle size; […].” CLAY discloses that “In various embodiments, the polymer particle size used is from about 5 to 500 micrometers […].” ([0057]). CLAY does not describe any “extrinsic particles” in their powdered (milling or griding to reduce particle sizes) biodegradable polymer particles (instant claims 27-30).
CLAY teaches that: “The term "implantable" as utilized herein refers to a biocompatible device (e.g., drug depot) retaining potential for successful placement within a mammal. The expression "implantable device" and expressions of the like import as utilized herein refers to an object implantable through surgery, injection, or other suitable means whose primary function is achieved either through its physical presence or mechanical properties.” ([0036]). And that: “This product can be used to make the medical device (e.g., drug depot).” ([0055])(instant claims 33, 34, 39).
CLAY discloses that: “The at least two polymers that can be purified according to the methods provided herein include without limitations (i) polylactide (PLA) or (ii) one or more of poly (lactide-co-glycolide) (PLGA), polylactide (PLA), polyglycolide (PGA), D-lactide, D,L-lactide, L-lactide, […] or a combination thereof.” ([0060]).
CLAY discloses that: “The depot may optionally contain inactive materials such as buffering agents and pH adjusting agents such as potassium bicarbonate, potassium carbonate, potassium hydroxide, sodium acetate, sodium borate, sodium bicarbonate, sodium carbonate, sodium hydroxide or sodium phosphate; degradation/release modifiers; drug release adjusting agents; emulsifiers; preservatives such as benzalkonium chloride, chlorobutanol, phenylmercuric acetate and phenylmercuric nitrate, sodium bisulfate, sodium bisulfite, sodium thiosulfate, thimerosal, methylparaben, polyvinyl alcohol and phenylethyl alcohol; solubility adjusting agents; stabilizers; and/or cohesion modifiers. If the depot is to be placed in the spinal area, in various embodiments, the depot may comprise sterile preservative free material.” ([0091])(instant claims 32-34 & 37).
Response to Arguments:
Applicant's arguments filed 08/05/2025 have been fully considered but they are not persuasive.
Applicant argues that: “The sole remaining instant claim (28, as now amended) and its respective dependent claims, however, do not encompass the polymer mixtures of Clay and do not encompass the microparticulate polymer+ drug mixtures of Clay. The instant particles are of polymer not of a mixture of polymer and drug.” (p. 4, 2nd paragraph).
In response the examiner is reading the claims a open-ended not excluding any unrecited claim elements as the claims do not expressly exclude any claim elements other than “visible extrinsic particles of a size greater than 150 μ”. Additionally the clear intended use of the instantly claimed “purified powdered biodegradable thermoplastic polymer” is for drug delivery (instant Specification, p. 1, [0002]).
Applicant further argues that: “Given the fact that Clay fails to suggest or disclose a key limitation in the instant claims, then Clay cannot be said to anticipate the claimed invention.” (p. 4, 3rd paragraph). And that: “Even if one were to rely upon Clay as inherently disclosing the key limitation, Applicant notes that Clay fails to meet the inherency requirement of necessity of occurrence as regards the absence of extrinsic particles. Indeed, Clay is only concerned with removing monomers from the mixture of polymers. Accordingly, the filtration step disclosed by Clay ([0010], [0059]) is strictly for separating solvent (along with the monomer impurities) from the microparticles containing the mixture of two polymers. Clay fails to disclose a process wherein a molten polymer is filtered to remove extrinsic particles. Clays filtration fails to remove extrinsic particles from the microparticulate polymer mixture. Clay fails to provide the artisan with motivation to filter the molten polymer to remove extrinsic particles, because Clay does not even acknowledge the existence of extrinsic particles, and Clay only focuses on removal monomer by precipitating the mixture of polymer from a solvent/antisolvent mixture. As a result, Clay fails to inherently disclose a purified powdered biodegradable thermoplastic polymer that has been filtered in a molten state, thereby forming a polymer free from visible extrinsic particles of a size greater than 150 µm.” (p. 4, 4th paragraph).
In response the examiner argues that the instant claims are not directed to a process but include product-by-process steps. Applicant has provided no evidence that the particles of CLAY include extrinsic particles. MPEP §2113 makes clear that: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” And that: “‘The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature’ than when a product is claimed in the conventional fashion. […] Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.” In the instant case the examiner point out that: CLAY discloses biodegradable polymers including PGA, PLA and PLGA ([0027])(instant claim 31). And that: “Biodegradable polymers useful in the preparation of drug depots can be easily hot melt extrudable. In order to produce hot melt extrudable polymers many processes include three unit operations, (i) milling or grinding to reduce polymer particle size; […].” CLAY discloses that “In various embodiments, the polymer particle size used is from about 5 to 500 micrometers […].” ([0057]). CLAY does not describe any “extrinsic particles” in their powdered (milling or griding to reduce particle sizes) biodegradable polymer particles (instant claims 27-30). The fact that CLAY does not describe any “extrinsic particles” tends to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.
Claims 27-34, 37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by KOHN (US 6,455,526; published September, 2002).
Applicant Claims
Applicant claims are discussed above.
Disclosure of the Prior Art
KOHN discloses: “A new class of biodegradable pharmaceutical compositions useful as sustained release medicamentous compositions, including methods of making and methods of using these compositions, are described and claimed. The method of making these compositions include the steps of: a) dry mixing of a pharmaceutically active molecule with a biodegradable polymer; b) melt extruding the mixture to form a solid solution of the active molecule in the polymer; and c) pulverizing the solid solution to form microparticles such that they can be formed into injectable formulations.” (abstract, see whole document).
KOHN discloses that: “Surprisingly, it has now been found that solid solution of a biodegradable polymer and a pharmaceutically active molecule can be made by a melt extrusion process. Some of the advantages gained by the practice of the method of the present invention, individually and/or in combinations, are: a) the pharmaceutically active compound is essentially dissolved in the biodegradable polymer matrix forming a solid solution; b) the compositions of the present invention can be readily formed into microparticles; and c) the compositions of the present invention can be formulated into injectable formulations for the sustained release of the active compound. Advantageously, the compositions of the present invention are useful in the treatment of various CNS diseases.” (col. 3, lines 25-35).
KOHN discloses that: “Particularly preferred polymers suitable for the method of the present invention are polyesters. Specific examples of polyesters include polylactide, polyglycolide, polylactide-co-glycolide […]. A particularly preferred polyester is polylactide-co-glycolide (PLGA).” (col. 8, lines 59-65; claims 4-7)(instant claims 27-31, biodegradable thermoplastic polymer).
KOHN discloses that: “"Microparticles", "microspheres" or "microcapsules" shall mean any free flowing powder consisting substantially of spherical particles of 500 microns or less in diameter, usually 200 microns or less in diameter.” (col. 5, lines 10-15). KOHN does not describe any “extrinsic particles” in their powdered biodegradable polymer particles (instant claims 27-30)(instant claims 27-31, “purified powder biodegradable thermoplastic polymer”).
KOHN discloses that: “"Pharmaceutically acceptable carrier" is a solvent, dispersant, excipient, adjuvant or other material having acceptable toxicity, which is mixed with the composition of the present invention in order to permit the formation of a pharmaceutical composition, i.e., a dosage form capable of administration to the patient. One example of such a carrier is a pharmaceutically acceptable oil typically used for parenteral administration.” (col. 5, lines 35-43). And claims “The composition as set forth in claim 22 wherein said microparticles are added to a pharmaceutically acceptable solution to form an injectable suspension.” (claim 29)(instant claims 32-34, 37 & 39).
Arguments:
Applicant's arguments filed 08/05/2025 have been fully considered but they are not persuasive.
Applicant argues that: “the invention as now claimed is directed to "A purified powdered biodegradable thermoplastic polymer free from visible extrinsic particles of a size greater than greater than 150 µm, wherein the biodegradable thermoplastic polymer is selected from the group consisting of PLGA or PLA." (p. 5, last paragraph). And that: “The claims encompass and are directed to purified powdered particles of biodegradable thermoplastic polymer. The claims are not directed to purified powdered particles containing a mixture of pharmaceutically active molecule and biodegradable thermoplastic polymer.” (p. 6, 1st paragraph). And further that: “If Kohn requires the presence of a pharmaceutically active molecule in its microparticles, and the instant purified powdered biodegradable thermoplastic polymer does not contain a pharmaceutically active molecule, then Kohn cannot be properly deemed to anticipate the invention as claimed. The instant claims also do not encompass the drug-containing particles of Kohn.” (p. 6, 2nd paragraph).
KOHN discloses that: “Particularly preferred polymers suitable for the method of the present invention are polyesters. Specific examples of polyesters include polylactide, polyglycolide, polylactide-co-glycolide […]. A particularly preferred polyester is polylactide-co-glycolide (PLGA).” (col. 8, lines 59-65; claims 4-7)(instant claims 27-31, biodegradable thermoplastic polymer). KOHN discloses that: “"Microparticles", "microspheres" or "microcapsules" shall mean any free flowing powder consisting substantially of spherical particles of 500 microns or less in diameter, usually 200 microns or less in diameter.” [emphasis added](col. 5, lines 10-15). KOHN does not describe any “extrinsic particles” in their powdered biodegradable polymer particles (instant claims 27-30)(instant claims 27-31, “purified powder biodegradable thermoplastic polymer”).
In response the examiner argues that the instant claims are not directed to a process but include product-by-process steps. Applicant has provided no evidence that the particles of KOHN include extrinsic particles. MPEP §2113 makes clear that: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” And that: “‘The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature’ than when a product is claimed in the conventional fashion. […] Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.” In the instant case the examiner point out that: KOHN discloses that: “Particularly preferred polymers suitable for the method of the present invention are polyesters. Specific examples of polyesters include polylactide, polyglycolide, polylactide-co-glycolide […]. A particularly preferred polyester is polylactide-co-glycolide (PLGA).” [emphasis added](col. 8, lines 59-65; claims 4-7)(instant claims 27-31, biodegradable thermoplastic polymer). KOHN discloses that: “"Microparticles", "microspheres" or "microcapsules" shall mean any free flowing powder consisting substantially of spherical particles of 500 microns or less in diameter, usually 200 microns or less in diameter.” [emphasis added](col. 5, lines 10-15). KOHN does not describe any “extrinsic particles” in their powdered biodegradable polymer particles (instant claims 27-30)(instant claims 27-31, “purified powder biodegradable thermoplastic polymer”). The fact that KOHN does not describe any “extrinsic particles” tends to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.
Applicant is advised that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Conclusion
Claims 27-34, 37 and 39 are pending and have been examined on the merits.
Claims 27 is objected to. Claims 29-32, 34, 37 and 39 are rejected under 35 U.S.C. 112(b); and claims 27-34, 37 and 39 are rejected under 35 U.S.C. 102(a)(1). No claims allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619