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 .
Information Disclosure Statement
The information disclosure statements filed February 8, 2024 and November 17, 2025 are acknowledged and have been considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is too short in length (28 words). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
In claim 14, the applicant recites “…creating a radiopaque material and a biodegradable linker complex.” The examiner interprets this phrase to describe a method step in which a complex is formed between two components, with the components being a radiopaque material and a biodegradable linker.
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 17 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 17 recites the phrase “target properties” at the end of the claim. The term “target” in the context of “properties” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite meaning, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what properties are considered by the applicant to be “target properties.” While the specification speaks to the method of making microspheres possibly including modifying the surface properties, density, and biodegradation of the microspheres, it is unclear whether “target properties” is meant to specifically refer to this finite list of properties or other properties not explicitly stated. For the purpose of examination, the examiner will interpret “target properties” to include any property of the microspheres.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 8, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qie (Qie, F., et. al., Nanoscale, 2015).
Regarding claim 1, Qie teaches a microsphere comprising a radiopaque material (gold) and a biodegradable material (alginate) (pg. 2483, Scheme 2).
Regarding claim 2, Qie teaches a microsphere wherein the radiopaque material is gold nanoparticles (pg. 2483, Scheme 2).
Regarding claim 5, Qie teaches a microsphere wherein the alginate microsphere (microcapsule) is coated by the radiopaque gold nanoparticles (pg. 2483, Scheme 2).
Regarding claim 6, Qie teaches a microsphere wherein the biodegradable material is alginate (pg. 2483, Scheme 2).
Regarding claim 8, Qie teaches a microsphere wherein the radiopaque material includes gold (pg. 2483, Scheme 2).
Regarding claim 11, Qie teaches a method of making a microsphere comprising coating biodegradable alginate microcapsules with radiopaque gold nanoparticles (pg. 2486, “Fabrication of gold-loaded alginate MCs and discs”).
Regarding claim 12, Qie teaches a method of making a microsphere comprising providing radiopaque gold nanoparticles, combining the gold nanoparticles with biodegradable alginate microcapsules to define a biodegradable radiopaque microsphere, and finish processing the microsphere through washes (pg. 2486, “Fabrication of gold-loaded alginate MCs and discs”).
Claims 1, 3, 7, 9, 12, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cilliers (Cilliers, R., et. al., Magn. Reson. Med., 2008).
Regarding claim 1, Cilliers teaches a microsphere comprising a radiopaque material (gadolinium) and a biodegradable material (polyvinyl alcohol) (pg. 899, Fig. 1).
Regarding claim 3, Cilliers teaches a microsphere wherein the biodegradable material is chemically bound to the radiopaque material via ester linkage of the gadolinium-bound chelating agent to the polyvinyl alcohol (pg. 899, Fig. 1).
Regarding claim 7, Cilliers teaches a microsphere wherein the biodegradable material includes polyvinyl alcohol (pg. 899, Fig. 1).
Regarding claim 9, Cilliers teaches a method of making a microsphere comprising linking a biodegradable material (polyvinyl alcohol) with a radiopaque material (gadolinium) via metal chelation and ester linkage of the chelator to the polymer (pg. 899, Fig. 1)
Regarding claim 12, Cilliers teaches a method of making microspheres comprising providing a radiopaque material (gadolinium), combining the radiopaque material with a biodegradable (polyvinyl alcohol) to define a radiopaque microsphere, and finish processing the microspheres (washing) (pg. 899, first and second paragraphs of Methods section).
Regarding claim 14, Cilliers teaches creating a complex between a radiopaque material (gadolinium) and a biodegradable linker (DTPA) (pg. 899, Fig. 1). The diethylenetriaminepentaacetate (DTPA) moiety forms a complex with gadolinium via chelation and acts as a linker as it covalently connects the gadolinium-containing complex to the polymer microsphere through a biodegradable ester linkage.
Regarding claim 15, Cilliers teaches a complex between the radiopaque gadolinium and the DTPA linker including carboxyl groups and amines (pg. 899, Fig. 1).
Claims 1-2, 4, 7, 10, 12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou (Zhou, Y., et. al., ACS Appl. Mater. Interfaces, 2020).
Regarding claim 1, Zhou teaches a microsphere comprising a radiopaque material (iron) and a biodegradable material (methoxy poly(ethylene glycol)-block-poly(L-lactide) (mPEG-b-PLLA)) (pg. 22581, Abstract).
Regarding claim 2, Zhou teaches a microsphere wherein the radiopaque material is an iron-based metal organic framework (MOF) nanoparticle.
Regarding claim 4, Zhou teaches a microsphere wherein the iron-based MOF is encapsulated by the biodegradable mPEG-b-PLLA (pg. 25581, Abstract).
Regarding claim 7, Zhou teaches a microsphere wherein the biodegradable material includes poly(ethylene glycol) and poly(L-lactide) (pg. 25581, Abstract).
Regarding claim 10, Zhou teaches a method of making a microsphere comprising encapsulating radiopaque iron MOFs with biodegradable mPEG-b-PLLA (pg. 25583, section 2.4).
Regarding claim 12, Zhou teaches a method of making microspheres comprising providing radiopaque iron MOF nanoparticles, combining the radiopaque material with biodegradable mPEG-b-PLLA to define biodegradable radiopaque microspheres, and finish processing the biodegradable radiopaque microspheres by centrifugation and lyophilization (pg. 22583, section 2.4).
Regarding claim 16, Zhou teaches the method of claim 12 wherein the radiopaque material is an iron-based MOF, which is a metal-organic complex (pg. 22853, sections 2.2 and 2.4).
Claims 1, 4, 7-8, 10, 12, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meng (Meng, W.J., et. al., J. Biomater. Appl., 2015).
Regarding claim 1, Meng teaches a microsphere comprising a radiopaque material (lipiodol) and a biodegradable material (polyvinyl alcohol) (pg. 134, Fig. 1).
Regarding claim 4, Meng teaches a microsphere wherein the radiopaque lipiodol is encapsulated by the polyvinyl alcohol (pg. 134, Fig. 1).
Regarding claim 7, Meng teaches a microsphere comprising polyvinyl alcohol (pg. 134, Fig. 1).
Regarding claim 8, Meng teaches a microsphere comprising lipiodol, which contains iodine (pg. 134, Fig. 1).
Regarding claim 10, Meng teaches a method of making a microsphere comprising encapsulating lipiodol in polyvinyl alcohol (pg. 134, Preparation of LRMs).
Regarding claim 12, Meng teaches a method of making microspheres comprising providing radiopaque lipiodol, combining the radiopaque material with polyvinyl alcohol to define biodegradable radiopaque microspheres, and finish processing the biodegradable radiopaque microspheres by washing, sieving, and sterilizing (pg. 134, Preparation of LRMs).
Regarding claim 17, Meng teaches a method of making microspheres wherein the finish processing includes obtaining biodegradable radiopaque microspheres of uniform size distribution and target properties (pg. 134, Preparation of LRMs). The sieving step enabled splitting the microspheres into subgroups based on their diameters, providing uniform size distribution. The sterilization step provided microspheres with the property of sterility.
Claims 1-2, 4, 10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Idris (Idris, M., et. al., Sci. Rep., 2018).
Regarding claim 1, Idris teaches a microsphere comprising a radiopaque material (iron oxide nanoparticle) and a biodegradable material (poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV)) (pg. 1, Abstract).
Regarding claim 2, Idris teaches a microsphere wherein the radiopaque material is an iron oxide nanoparticle (pg. 1, Abstract).
Regarding claim 4, Idris teaches a microsphere wherein the radiopaque iron oxide nanoparticles are encapsulated by the biodegradable PHBV polymer (pg. 7, Conclusions).
Regarding claim 10, Idris teaches a method of making a microsphere comprising encapsulating radiopaque iron oxide nanoparticles with biodegradable PHBV polymer (pg. 7, Preparation of magnetic microspheres).
Regarding claim 12, Idris teaches a method of making a microsphere comprising providing radiopaque iron oxide nanoparticles, combining the radiopaque material with biodegradable PHBV to define biodegradable radiopaque microspheres, and finish processing the biodegradable radiopaque microspheres by centrifugation, washing, and lyophilization (pg. 7, Preparation of magnetic microspheres).
Regarding claim 13, Idris teaches a method of making microspheres wherein the radiopaque iron oxide nanoparticles incorporated in the microspheres are synthesized by adding either lauric acid or oleic acid surfactants to raw radiopaque iron precursors (pg. 7, Synthesis of superparamagnetic iron oxide nanoparticles).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of copending Application No. 19/233,351 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claim is drawn to a microsphere comprising a radiopaque material and a biodegradable material.
The copending claims are drawn to a microsphere comprising a radioactive core and a bioresponsive shell comprising a radiopaque material. Claims 11-14 require the radiopaque shell further comprises a biodegradable water-soluble polymer. Thus, these claims require the microsphere to comprise a biodegradable material and a radiopaque material in the bioresponsive shell.
The instant and copending claims differ because the copending claims recite a radioactive core not recited by the instant claims. Nevertheless, the subject matter of the copending claims is within the scope of that of the instant claims, and thereby effectively anticipates the subject matter of the instant claims. This results in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5-6, and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/233,351 in view of Qie.
Claims 1-14 of copending Application No. 19/233,351 do not expressly teach all the features of the claimed invention, such as requiring the bioresponsive material be biodegradable.
However, this feature is known in the art. As noted in the current rejections, Qie teaches a microcapsule comprising radiopaque gold nanoparticles and alginate as a bioresponsive shell material (pg. 2483, Scheme 2). As alginate is more specifically biodegradable, the microparticle of Qie anticipates claims 1-2, 5-6, and 8 of the instant application.
Therefore, as claims 1-14 of copending Application No. 19/233,351 and Qie disclose microparticles comprising radiopaque and bioresponsive materials, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the microparticle of claims 1-14 of copending Application No. 19/233,351 with the use of a biodegradable material such as alginate as a bioresponsive material as taught by Qie as this is a known technique in the same art of microparticles. This would result in the predictable result of making a microsphere comprising a radiopaque material and a biodegradable material.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric P Mosher whose telephone number is (571)272-3258. The examiner can normally be reached Monday-Friday 9am-5pm.
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/E.P.M./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612