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 .
Priority
The instant application was filed 07 August 2024 and is the continuation of 17/503,063 field 15 October 2021. The Applicant claims priority to provisional applications 63/143,884 and 63/093,271 filed 31 January 2021 and 18 October 2020, respectively. Therefore, the effective filing date of the instant application is 18 October 2020.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6, 8-16) and PEG as the crosslinked biodegradable polymer matrix and PLGA as the non-crosslinked biodegradable polymer in the supplemental reply filed on 14 August 2026 is acknowledged.
Claims 17-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the supplemental reply filed on 14 August 2026.
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.
Claim 4 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 4 recites a microparticle with a size of about 0.5 picoliters to about 1.5 milliliters. It is unclear if the Applicant is claiming a volume or diameter/particle size in the recited range. Therefore, the metes and bounds of the limitation cannot be determined.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6, 8-13, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liggins et al. (WO 2006/002365 A2).
Regarding claim 1, Liggins teaches an injectable (pg. 12) microparticle composition comprising a drug (abs, entire teaching) that may comprise PLGA and PEG or PLGA-block-PEG (pgs. 3-4). Liggins describes methods of polymerizing (pg. 6) and crosslinking the polymers (pg. 39) and dispersing the polymers in a solvent to form gels (pg. 39), which is interpreted as resulting in entrapment of the non-crosslinked polymer in the crosslinked polymer matrix. The mixture is interpreted as forming a composite mixture as a result of two different materials.
The limitations of “formed by polymerizing and crosslinking a photocrosslinkable polymerizable precursor or condensation polymerizable precursor,” “the non-crosslinked biodegradable polymer is precipitated in situ within the crosslinked polymer matrix from a homogeneous solution,” and “released from the composite biodegradable microparticle in a controlled manner upon implantation in a subject” are interpreted as product-by-process limitations. "[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 2 and 3, the microparticles may have irregular shapes (pg. 97) and may be spherical or ellipsoid in shape (pg. 9).
Regarding claim 4, the microparticles may have a high loading of more than 50% (pg. 2) or a diameter size of about 0.5-1000 microns (pg. 9), which is interpreted as having a “size” of about 0.5 picoliters to about 1.5 milliliters.
Regarding claim 5, the microparticles may have a diameter of about 0.5 microns to 1000 microns (pg. 5).
Regarding claim 6, the microparticles having irregular shapes, as well as spherical or ellipsoid shapes, are interpreted as a plurality of shapes.
Regarding claim 8, the composition comprising PEG (pgs. 3-4) (Applicant’s election) is interpreted as addressing the precursor limitations.
Regarding claim 9, the composition comprising PLGA (pgs. 3-4) (Applicant’s election) is interpreted as addressing the solubility limitations.
Regarding claim 10, the composition comprising PLGA (pgs. 3-4) (Applicant’s election) is interpreted as addressing the hydrophobic non-crosslinked biodegradable polymer choices.
Regarding claims 11 and 12, the polymers used in the composition may have a molecular weight of less than 100,000 g/mol depending on the type of polymer and the desired application (pg. 36).
Regarding claim 13, Applicant’s election of PLGA for the non-crosslinked biodegradable polymer is interpreted as addressing the limitations for hydrophobicity and/or solubility.
Regarding claim 15, the microparticle composition may comprise a drug (abs).
Regarding claim 16, the microparticle composition may comprise excipients, such as visualization agents (pgs. 60-61).
Liggins does not teach an exact combination of the components recited in claim 1.
In regards to selecting the combination of the components recited in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Liggins teaches an injectable (pg. 12) microparticle composition comprising a drug (abs, entire teaching) that may comprise PLGA and PEG or PLGA-block-PEG (pgs. 3-4), whereas the claimed invention is directed towards a composite biodegradable microparticle comprising a crosslinked biodegradable polymer matrix, a non-crosslinked biodegradable polymer, and a therapeutic agent. Since Liggins teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liggins et al. (WO 2006/002365 A2), as applied to claim(s) 1-6, 8-13, 15, and 16 above, in view of Lanao et al. (Physicochemical Properties and Applications of Poly(lactic-co-glycolic acid) for Use in Bone Regeneration, Tissue Engineering, 2013).
In regards to claim(s) 1-6, 8-13, 15, and 16, Liggins, as applied supra, is herein applied in its entirety for its teachings of a microparticle composition comprising a drug, PLGA, and PEG.
Liggins does not specify that the non-crosslinked biodegradable polymer is endcapped in claim 14.
Lanao teaches that PLGA (non-crosslinked biodegradable polymer) can be endcapped or have end-terminal modifications in order to affect different physicochemical characteristics, such as delaying degradation time (pg. 382).
Since Liggins does not specify that the non-crosslinked biodegradable polymer is endcapped in claim 14, one of ordinary skill in the art would have been motivated to use Lanao’s teaching of endcapping PLGA to provide certain physicochemical properties to the compositions, such as delaying degradation time, for tissue engineering (pg. 380). A skilled artisan would have been motivated to combine the teachings because Liggins teaches microparticle compositions for sustained or local release (pg. 2) and improved degradation and drug release (pg. 3) for tissue engineering (pg. 8). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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