DETAILED ACTION
Status of the Claims
Claims 1, 3 and 6-11 are pending in the instant application. Claims 10-11 have been withdrawn based upon Restriction/Election as. Claims 1, 3 and 6-9 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All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.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 04/18/2018 the filing date of KR-10-2018-0044857. The examiner notes that KR-10-2018-0044857 does not expressly disclose the spherical micro-particles have a number of pores and the deoxycholic acid is contained in the pores, however, the examiner is reading this as being implicitly/inherently disclosed based on the method of making (p. 19, [0086] through [0092]).
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, 3 and 6-9 is 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.
Claim 1 has been amended to recite “wherein a surfactant used upon preparation of the micro-particles does not exist in the finally prepared micro-particles”, however, the claim also recites “micro-particles comprising deoxycholic acid”. Where the instant Specification makes clear that: “Since DCA is one of the strong surfactants in the bile salt family, DCA administration results in the destruction of surrounding tissues from the injection site.” (p. 2, last paragraph; [0008]). DCA being deoxycholate or deoxycholic acid which is contained within the claimed micro-particles. Therefore it is unclear exactly what “surfactant used upon preparation of the micro-particles does not exist in the finally prepared micro-particles”. Appropriate clarification is required. Claims 3 and 6-9 are rejected for inheriting the same issue.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over KOLODNEY (US 7,754,230; published July, 2010) in view of Samstein et al. (“The use of deoxycholic acid to enhance the oral bioavailability of biodegradable nanoparticles,” 2008; ELSEVIER; Biomaterials, Vol. 29, pp. 703-708); LIM (US 2011/0200679; published August, 2011); BARUA (US 2017/0292109 A1; published October, 2017) and Katou et al. (“Kinetics of solvent extraction/evaporation process from PLGA microparticle fabrication,” 2008, ELSEVIER; International Journal of Pharmaceutics, Vol. 364, pp. 45-53); and as evidenced by REGE (WO 98/12987; published September, 1997).
Applicants Claims
Applicant claims a composition for subcutaneous injection, containing deoxycholic acid, the composition being for non-surgically removing localized fat deposits, comprising micro-particles containing deoxycholic acid and a biodegradable polymer, wherein the micro-particles are spherical particles having a smooth outer surface on which no pores are observed and which does not cause aggregation between particles, a plurality of pores formed in an interior of each of the micro-particles, and deoxycholic acid contained in the pores, the micro-particles having an average diameter of 30 to 70 μm and continuously releasing the deoxycholic acid for 1 to 3 months after sub/cutaneous injection to maintain a lipolytic effect, wherein a surfactant used upon preparation of the micro-particles does not exist in the finally prepared micro-particles, and
wherein the micro-particles are obtainable by a process comprising: (i) preparing a W1/O/W2 double emulsion by crossing, in micro-channels, a first mixture in which deoxycholic acid is dissolved in water, a second mixture in which the biodegradable polymer and a surfactant are dissolved in an organic solvent, and a third mixture containing a surfactant is dissolved in water, and collecting the W1/O/W2 double emulsion in a water bath containing the third mixture; and (ii) sequentially stirring the collected W1/O/W2 double emulsion at 16 to 18 °C, at 30 to 50 °C, and at 0 to 15 °C, and then washing the microparticles several times with purified water and freeze-drying the micro-particles (instant claim 1).
Determination of the scope
and content of the prior art (MPEP 2141.01)
KOLODNEY teaches compositions useful for reduction of localized fat deposits in patients in need thereof using pharmacologically active detergent compositions (see whole document, particularly the title, abstract and Field of Invention sections). KOLODNEY further teaches that: "The methods may use a variety of pharmacologically active detergents as described herein. In a more preferred embodiment, the active detergent in the unit dose is a bile salt, most preferably sodium deoxycholate." [emphasis added](col. 4, lines 18-22)(instant claims 1 & 3, sodium salt of deoxycholic acid). KOLODNEY further claims the method for non-surgical removal of a localized fat deposit by administration of deoxycholic acid (claim 1). And that: “In embodiments of the present invention, the pharmacologically active detergent composition is administered by subcutaneous injection directly into fat tissue.” (col. 12, lines 19-21)(instant claim 1, “A composition for subcutaneous injection […] the compositions being for non-surgically removing localized fat deposits […].”).
KOLODNEY teaches micro-particles including said pharmacologically active detergent such as deoxycholic acid, particularly micelle micro-particles and that: “In some embodiments, an average particle size of micelles in a composition of the present invention is contemplated to be in the range of 1 nanometer to 100 micrometers, 10 nanometers to 50 micrometers, 100 nanometers to 1 micrometers, etc. Moreover, the shape of the micelle can vary and can be, for example, prolate, oblate or spherical; spherical micelles are most typical.” (col. 15, lines 45-67)(instant claim 1, “an average particle diameter of the micro-particles is 30 to 70 μm”). KOLODNEY further teaches that "The compositions of the present invention can be formulated so as to provide quick, sustained or delayed release of the active ingredient after administration to the patient by employing procedures known in the art." (col. 23, lines 18-21).
KOLODNEY teaches that “One other embodiment contemplates one or more methods described herein to reduce fat deposits under the eye, chin, or arm, as well as the buttock, calf, back, thigh, ankle, or stomach of a mammal. In another embodiment, the methods may reduce specific types of fat deposits such as, for example, eyelid fat herniation, lipomas, lipodystrophy, buffalo hump lipodystrophy, or fat deposits associated with cellulite.” (col. 4, lines 29-32)(instant claims 7-8).
KOLODNEY teaches that “The present invention relates to the use of one or more pharmacologically active detergents (e.g., bile salts) to reduce subcutaneous fat accumulations in a mammal by administering such formulation locally to a target site.” (col. 6, lines 27-30). And further that “In preferred embodiments, a unit dose comprises, consists essentially of, or consists of one or more pharmacologically active detergent(s) in an injectable formulation […].” [emphasis added](col. 13, lines 55-57)(instant claim 9).
KOLODNEY teaches using multiple injections for administration (paragraph bridging cols. 24-25), and teaches “a depot for sustained release” (col. 25, lines 35-40).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of KOLODNEY is that KOLODNEY does not expressly teach: the micro-particles include a biodegradable polymer such as polylactide-co-glycolide (PLGA), each having a smooth appearance and a number of pores formed therein, the deoxycholic acid being contained in said pores, or a surfactant is used upon preparation of the microparticles is removed and thus does not exist in the finally prepared micro-particles.
Samstein et al. teaches that “Nanoparticles of synthetic poly-esters such as poly(lactic acid), poly(glycolic acid), and their copolymers poly(lactide-co-glycolide) (PLGA) are often chosen due to their biocompatibility and versatility in encapsulating a variety of drugs and biologics, as well as their ability to tune the dynamics of drug release by varying monomer ratios and polymer molecular weight.” (p. 703, col. 2, lines 13-20). And that “Here, we describe a system where PLGA particles are orally delivered in a non-covalently associated emulsion of DCA.” (DCA is deoxycholic acid) (p. 704, col. 1, lines 35-37). Samstein et al. teaches their PLGA particles “were prepared using a modified double emulsion (W/O/W) process” (p. 704, §2.1)(instant claim 1).
LIM teaches a method of preparing a sustained-release microsphere which can control the long-term release of a drug, wherein the drug is loaded in a carrier comprising a biodegradable polymer, the method including a solvent intraexchange evaporation method by means of co-solvent is used for suppressing the initial burst release of a physiologically active substance, to release the physiologically active substance in the body continuously and uniformly (see whole document, particularly the abstract). LIM teaches the biodegradable polymer such as polylactide, polyglycolide, poly(lactide-co-glycolide)(PLGA)([0022]-[0023]).
LIM teaches that "it is believed that the addition of the co-solvent successfully suppresses the initial burst release by preventing the movement of physiologically active substance toward a surface at the time of evaporating a solvent by means of precipitating the physiologically active substance in a water phase and helping the hardness of biodegradable polymer to make emulsion relatively harder and reduce the porosity of the surface." ([0029], Figure 1), thereby clearly teaching that the biodegradable polymer microspheres are porous and have a smooth surface (instant claim 1, "wherein the micro-particles are spherical particles having a smooth outer surface on which no pores are observed and which does not cause aggregation between particles, a plurality of pores formed in an interior of each of the micro-particles").
LIM makes clear that: “In addition, because the co-solvent used in the present invention is completely removed through the process of solvent removal, the present invention provides a sustained-release microsphere which is safe to the human body and has an excellent suppressive effect on the initial burst release.” ([0032]).
Additionally, it is known in the art pertaining to methods of producing such PLGA spherical particles that water-in-oil in-water (W/O/W) emulsions are used with hydrophilic bioactive substances and water-in-oil (W/O) emulsions are used with hydrophobic bioactive substances (see, e.g., LIM, [0002] & Jain et al. 1, §§3.1.1.1 & 3.1.1.2)(instant claim 2). Additionally, LIM teaches dissolving goserelin acetate in the aqueous phase and dissolving the biodegradable polymer (RG502H/RG503H), surfactant (Span 80) in the organic phase (methylene chloride, dichloromethane)([0038])(instant Specification p. 15, [0079]-[0081] “dissolving a biodegradable polymer and a surfactant in an organic solvent to prepare a second mixture”). Thus, the biodegradable polymer is hydrophobic and the active agent is hydrophilic and thus would have been contained within the pores of the microspheres (instant claim 1, “a plurality of pores is uniformly formed in an interior of each of the micro-particles, and deoxycholic acid is uniformly distributed inside each of the pores). REGE discloses that: “The microparticles of this invention were prepared by a double emulsion technique which is known to produce internal pores.” (p. 16, lines 16-17), and “double-emulsion systems (such as water-in-oil-in-water)” (p. 3, lines 16-17). Therefore, one of ordinary skill would have recognized that a W/O/W process would have resulted in internal pores created by the inner aqueous phase in which the water-soluble drug is contained.
LIM further teaches the release of the active species Goserelin from the microspheres for at least 28 days (i.e. about 1 month)(Table 4)(instant claim 1, “the micro-particles […] continuously release deoxycholic acid for 1 to 3 months after subcutaneous injection to maintain a lipolytic effect”).
BARUA teaches PLGA microparticles (see whole document), and particularly that: “One aspect of the invention is directed to methods of forming microparticles using a flow focusing device. The method comprises obtaining an organic solution comprising a biodegradable and biocompatible polymer, such as poly(D,L-lactide-co-glycolide) (PLGA). Two aqueous solutions comprising a surfactant, such as polyvinyl alcohol (PVA), are also obtained. The organic solution is co-injected with a stream of the first aqueous solution, referred to herein as a "carrier" stream, into a flow focusing tube. The combined streams are introduced into the second aqueous solution to form microparticles of the PLGA in the second aqueous solution. The organic solvent is then evaporated and the PVA removed.” [emphasis added]([0026])(instant claim 1, “wherein a surfactant is used upon preparation of the micro-particles does not exist in the finally prepared micro-particles”).
Katou et al. teaches the kinetics of solvent extraction/evaporation process for PLGA microparticle fabrication (see whole document), and particularly teaches production of PLGA microparticles using a “microchannel-operated mixer used for emulsification of the PLGA/DCM-phase (o-phase) in the w-phase (Fig. 1, step 1)” and that “it can be concluded that in the present experiments virtually all DCM was extracted into the water phase during the processing in the micromixer. Therefore, the time needed for solvent removal in the preparation of PLGA microparticles by conventional solvent extraction/evaporation must primarily be governed by the solvent evaporation from the aqueous extraction phase.” (p. 50, col. 1, 2nd paragraph). Katou et al. teaches PLGA particles with smooth surfaces and no aggregates (p. 51, Figure 8(d)).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sustained-release microsphere which can control the long-term release of a drug, wherein the drug is loaded in a carrier comprising a biodegradable polymer, as taught by LIM & Samstein et al., for sustained release of the deoxycholic acid drug in order to provide sustained release of the sample per the teachings of KOLODNEY (col. 23, lines 18-21); and to avoid repeated injections at the site of desired fat removal, to utilize a state-of-the-art microfluidic process for the production of the deoxycholic acid PLGA microspheres as a continuous process with good control over particle properties such as size/shape, and that using microchannel-operated mixer for emulsification of o-phase with w-phase removes virtually all the solvent (DCM)(Katou et al.).
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 effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Response to Arguments:
Applicant's arguments filed 06/25/2025 have been fully considered but they are not persuasive.
Applicant argues that: “The Office's predictability/routine rationale is contradicted by the Specification's own experimental record” (p. 8, item A), and particularly that: “Applicant's record demonstrates that DCA behavior in the claimed system is not a simple "hydrophilic drug in PLGA" situation and is not predictable by routine parameter tuning. The Specification expressly reports that, when injection conditions fall outside the disclosed pressure range, deoxycholic acid is not uniformly contained and "the drug release period thus becomes impossible to control." The Specification also reports that when the disclosed stirring conditions are not followed, "aggregation between particles occurs or pores are generated on the surfaces ... [so] the surface ... [is] not formed evenly," and that only within the disclosed stirring-condition range is it possible to prepare micro-particles "with even surfaces and no aggregation therebetween." Thus, the Office's conclusions of predictability/routine optimization are rebutted by the Specification itself: the claimed structural outcome is not an inherent or routinely achieved result across the cited art; it is conditional and highly sensitive to the claimed microchannel/processing framework.” (p. 9, paragraphs 1-2).
In response the examiner argues that the instantly rejected claims are directed to compositions of matter and not methods of making. The rejected composition claims are not limited by the method(s) described in the Specification. Newly, cited REGE discloses that: “The microparticles of this invention were prepared by a double emulsion technique which is known to produce internal pores.” (p. 16, lines 16-17), and “double-emulsion systems (such as water-in-oil-in-water)” (p. 3, lines 16-17). Therefore, one of ordinary skill would have recognized that a W/O/W process would have resulted in internal pores created by the inner aqueous phase in which the water-soluble drug is contained.
Applicant argues that “Improper inherency / unsupported assumption regarding "pores" and localization of the active” and particularly that: “ In response to Applicant's prior arguments, the Office asserts that "due to the polymer being hydrophobic, and the active agent being hydrophilic, it would have been contained within the pores of the microspheres." This is not a legally sufficient inherency showing. The amended claim does not merely require that an active agent be "inside" a PLGA matrix; it requires a specific internal pore architecture and localization consistent with the Specification, including that the outer surface is smooth with no pores observed while a plurality of pores are formed in the interior and DCA is contained in those pores. The Office does not cite any teaching in the references that necessarily produces this particular internal-pore/ surface-no-pore morphology for DCA-loaded PLGA micro-particles-especially together with the additional limitations below. Inherency requires inevitability: the missing limitation must be necessarily and inevitably present in the prior art product. It is not enough that the limitation might occur, or could be achieved, under some set of conditions.” (p. 9 ,item B).
In response the examiner cites REGE discloses that: “The microparticles of this invention were prepared by a double emulsion technique which is known to produce internal pores.” (p. 16, lines 16-17), and “double-emulsion systems (such as water-in-oil-in-water)” [emphasis added](p. 3, lines 16-17). Therefore, one of ordinary skill would have recognized that a W/O/W process would have resulted in internal pores created by the inner aqueous phase in which the water-soluble drug is contained.
Applicant further argues that: “The cited art does not teach or suggest the amended claim's integrated combination of: (i) microchannel W1/O/W2 formation, (ii) sequential temperature stirring, and (iii) the resulting structural state: smooth pore-free exterior, interior pores containing DCA, no aggregation, and surfactant absent” (p. 9, item C). And that: “amended claim is not drawn to a generic W/O/W microsphere.” And further that: “The Office also cites Ding and Chong. for general propositions about microfluidic double-emulsion droplet generation ( e.g., size control by channel dimensions and scalability by parallelization). Those review-type discussions at most show that microfluidic approaches are possible in the abstract; they do not supply a reasoned motivation to modify Kolodney, Samstein, and Lim to arrive at Applicant's specific integrated particle architecture, nor do they support a reasonable expectation that the claimed pore-free exterior/ non-aggregation morphology and surfactant-absent final state would result from such a modification. The claim requires, in a single composition, the specific structural results and processlinked framework disclosed in the Specification:
• W1/O/W2 formation by crossing, in micro-channels, the first mixture, the second mixture, and the third mixture, and collecting the W1/O/W2 double emulsion in a water bath
containing the third mixture;
• sequentially stirring the collected W i/O/W 2 double emulsion first at 16-18 °C, then at 30-50 °C, and finally at 0-15 °C, and then washing the micro-particles several times with purified water and freeze drying; and
• as a result, a smooth outer surface (no pores observed) with no aggregation between particles, an interior pore network with DCA contained therein, and a surfactant used in preparation that "does not exist in the finally prepared micro-particles."
Critically, the Specification explains why these sequential temperature steps are not arbitrary: varying temperature removes external solvent to smooth the surface while removing only internal solvent to create internal pores such that "only deoxycholic acid remains in the pores." The cited art does not teach this mechanism or this combination of structure and processing to achieve it.” (pp. 10-11, item C).
In response the examiner argues that the instantly rejected claims are directed to compositions of matter and not methods of making. The rejected composition claims are not limited by the method(s) described in the Specification. The examiner cites REGE discloses that: “The microparticles of this invention were prepared by a double emulsion technique which is known to produce internal pores.” (p. 16, lines 16-17), and “double-emulsion systems (such as water-in-oil-in-water)” [emphasis added](p. 3, lines 16-17). Therefore, one of ordinary skill would have recognized that a W/O/W process would have resulted in internal pores created by the inner aqueous phase in which the water-soluble drug is contained.
Applicant further argues that: “The Office's "reasonable expectation of success" and "prima facie obvious" conclusion is not supported by an articulated reasoning that bridges the gaps to the amended claim” (p. 11, item D). And particularly that: “The Office's rationale effectively reduces the invention to a broad template ("PLGA microsphere + W1/O/W2 + DCA"), and then treats the amended claim's specific structural results (smooth pore-free outer surface, interior pores containing DCA, no aggregation, surfactant absent) as predictable or inherent. That reduction is unsupported because claim I is not satisfied by the mere presence of "PLGA + W1/O/W2 + DCA." The claim requires, as an integrated whole, (i) a smooth outer surface on which no pores are observed, (ii) no aggregation between particles, (iii) interior pores containing deoxycholic acid, and (iv) a final state in which the preparation surfactant does not exist, together with the specific micro-channel crossing/collection and the three-stage sequential temperature stirring that the Specification ties to achieving the foregoing structure. The Office does not map these combined limitations to the applied references and instead treats them as inherent or predictable, which is inconsistent with the Specification's comparative disclosures showing these features are not inevitable.” (pp. 11-12, item C).
In response the examiner argues that the instantly rejected claims are directed to compositions of matter and not methods of making. The rejected composition claims are not limited by the method(s) described in the Specification. The examiner cites REGE discloses that: “The microparticles of this invention were prepared by a double emulsion technique which is known to produce internal pores.” (p. 16, lines 16-17), and “double-emulsion systems (such as water-in-oil-in-water)” [emphasis added](p. 3, lines 16-17). Therefore, one of ordinary skill would have recognized that a W/O/W process would have resulted in internal pores created by the inner aqueous phase in which the water-soluble drug is contained. MPEP §2143.02 makes clear that: “Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness.” In the instant case a person having ordinary skill in the art, before the time of the claimed invention, would have had a reasonable expectation of success in producing a PLGA microparticle having an average size of 30-70 microns, and including a water-soluble drug species DCA, by a W/O/W process resulting in internal pore structure in which the DCA is contained for sustained release over an extended period of time, the microparticles having a smooth surface so as to not cause aggregation between the particles.
Applicant further argues the rejection appears to rely on hindsight reconstruction as “The cited references, even if combined, do not teach or suggest the amended claim as a whole, and the Specification's experimental record demonstrates that the claimed structure and sustained effect are not routine or inevitable outcomes.” (p. 12, 2nd paragraph).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Claims 1, 3 and 6-9 are pending and have been examined on the merits. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. Claims 1, 3 and 6-9 are rejected under 35 U.S.C. 112(b) and claims 1, 3 and 6-9 are rejected under 35 U.S.C. 103.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571) 272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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