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 .
Status of Application
The content of this office action is the same as the non-final rejection mailed 10/17/2025, and the response to the previous traversal is repeated from the nonfinal action and the holding of lack of unity is now explicitly made final.
Election/Restrictions
Lack of Unity
Receipt of Applicant’s Remarks filed on 01/14/2026 is acknowledged. Claims 2-15 and 17 are pending. Claims 1 and 16 remain canceled. Claims 3-7, 14, 15 and 17 have been withdrawn per restriction requirements. Claims 2, 8-13 are under examination in this application.
Maintained Rejections
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, “Hyaluronic acid-coated PEI-PLGA nanoparticles mediated co-delivery of doxorubicin and miR-542-3p for triple negative breast cancer therapy” (hereinafter referenced as Wang et al.) in view of Liu et al., “Development of Novel Lignin-Based Targeted Polymeric Nanoparticle Platform for Efficient Delivery of Anticancer Drugs” (hereinafter referenced as Liu), Olsson et al. (US 2014/0080992 A1) (both Liu and Olsson reference are cited in IDS filed 04/0/2021) and further in view of Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier (hereinafter referenced as Makadia).
Wang teaches a hyaluronic acid (HA)-decorated polyethyleneimine-poly)D,L-lactide-co-glycolide) (PEI-PLGA) nanoparticle system for targeted co-delivery of doxorubicin (DOX) and miR-54-3p for triple negative breast cancer (TNBC) therapy (abstract). Furthermore, Wang teaches ester bonds, (page 413, left col., last para.), hydrophobic Dox (page 418, left col., 1st para.), and hyaluronic acid (HA)-decorated polyethyleneimine-poly)D,L-lactide-co-glycolide) (PEI-PLGA) nanoparticles dispersed as monodispersed particles with a well-defined spherical core-shell structure (page 414, right col., last para.). The limitation of PLGA, core-shell nanoparticles, ester bonds are met in claim 2.
However, Wang fails to teach lignin in core-shell nanoparticles.
Liu teaches lignin-based targeted nanoparticles (NPs) platform, folic acid-polyethylene glycol-alkaline lignin conjugates (FA-PEG-AL), via self-assembly for delivery of anti-cancer drug (hydroxyl camptothecin, HCPT). Notably, Liu teaches that these lignin-based nanoparticles had particles size (~150 nm) and exhibited excellent biocompatibility, high drug loading efficiency, and prolonged blood circulation time (~7-fold of free HCPT, and enhanced cellular uptake (~5-fold of free HCPT) (Abstract).
Regarding claim 2, Liu teaches lignin-based nanoparticles (abstract) component of the instant composition.
Regarding claims 9 and 10, Liu teaches alkaline lignin (page 1731, paragraph 2.1). As noted in specification, paragraph (0022), lignin can be obtained commercially as alkaline lignin or as sodium lignosulfonate (both of which are more hydrophilic than native lignin), and either form may be used in practicing this instant invention.
Regarding claims 11-13, Liu teaches lignin-based nanoparticles had moderate particle size (~150 nm) (abstract). Therefore, this nanoparticle size falls within instant nanoparticle mean diameter range from 50 nm to 200 nm.
Olsson et al. teach graft co-polymers of lignin and poly(lactic acid) (lignin-g-PLA copolymer), methods of preparing these polymers (abstract).
Regarding claim 8, Olsson et al. teach Lignin-g-PLA copolymers have controllable PLA chain lengths and, in some embodiments, the PLA-chain length is controlled by varying one or more of lignin/lactide ratio and pre-acylation such as pre-acetylation of the lignin (paragraph 0007) and the ability to control the grafted PLA chain lengths and the degree of chain extension/cross-linking offers access to a broad spectrum of materials ranging from thermoplastics to thermosets (paragraph 0009). Furthermore, Olsson et al. disclose the structure and properties of the lignin-g-PLA can be tuned by changing the Stereoforms (L, D, or DL) of lactides and by utilizing different lignin sources (paragraph 0017) and in various embodiments, the use of co-monomers other than a lactide is without limitation (paragraph 0019). However, Olsson et al. do not disclose Lignin with PLGA. An article of interest by Makadia discloses polyester PLGA is a copolymer of poly lactic acid (PLA) and poly glycolic acid (PGA). It is the best defined biomaterial available for drug delivery with respect to design and performance. Poly lactic acid contains an asymmetric α-carbon which is typically described as the D or L form in classical stereochemical terms and sometimes as R and S form, respectively. The enantiomeric forms of the polymer PLA are poly D-lactic acid (PDLA) and poly L-lactic acid (PLLA). PLGA is generally an acronym for poly D,L-lactic-co-glycolic acid where D- and L- lactic acid forms are in equal ratio. In order to design a better controlled drug delivery device or system, it is essential to understand the physical, chemical and biological properties of PLGA. The physicochemical properties of optically active PDLA and PLLA are nearly the same. In general, the polymer PLA can be made in highly crystalline form (PLLA) or completely amorphous (PDLA) due to disordered polymer chains. PGA is void of any methyl side groups and shows highly crystalline structure in contrast to PLA. PLGA can be processed into almost any shape and size, and can encapsulate molecules of virtually any size. It is soluble in wide range of common solvents including chlorinated solvents, tetrahydofuran, acetone or ethyl acetate (pages 2-3, paragraphs 2.1-2.2). Thus, one of ordinary skill in the art would have reasonable expectation of a better drug delivery system when substituting PLA with PLGA due to the above described properties. Through routine experimentation, one would be able to envisage to replace PLA with PLGA with the desired lignin to PLGA ratio of instant invention.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the drug delivery system of PLGA core-shell nanoparticles with hydrophobic drug molecule as taught by Wang and incorporate lignin-based targeted polymeric nanoparticle platform of Liu to improve biocompatibility, high drug loading efficiency and prolonged blood circulation and enhanced cellular uptake. One would have been motivated to do so because improving a drug delivery system to achieve the desired therapeutic effects, better targeting site of action with enhanced tissue permeability and prolonged drug distribution in blood stream and biocompatibility translate to improved clinical outcomes and better tolerability of cancer drugs, for example. The combine teachings of Olsson and Makadia renders the possibility of graft co-polymers of lignin and poly(lactic acid) (lignin-g-PLA copolymer), and substituting PLGA for PLA and tune to the desired ratios. One of skill in the art would be able to optimize the ratio of lignin to PLGA to have the co-polymers perform in the desired dispersion, interaction and polymerization in the composition.
One of ordinary skill in the art would have been motivated to do this because all references are drawn to core-shell nanoparticles compositions comprising graft polymer lignin and PLGA with a hydrophobic molecule, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141. One of ordinary skill in the art would have had a reasonable expectation of success to include the components in their corresponding weight ratio and nanoparticle diameter ranges as taught by each of the references and produce a functional core-shell nanoparticle comprising lignin-PLGA drug delivery composition.
Response to Previous Remarks are Repeated
Rejection under 35 USC § 103
Applicant asserts cited references (1) Wang, (2) Liu, (3) Olsson, and (4) Makadia failed to establish a prima facie case to support the rejection and failed to suggest motivation to combine the references, and specifically failed to pairwise combinations of reference. Additionally, Applicant asserted that previous Office Action failed to show that the claimed inventions lack a special technical feature over Wang.
Applicant's arguments filed 06/3/2024 have been fully considered but they are not persuasive.
In regards to special technical feature. As stated in previous Office Action on page 3, Wang teaches a hyaluronic acid (HA)-decorated polyethyleneimine-poly)D,L-lactide-co-glycolide) (PEI-PLGA) nanoparticle system for targeted co-delivery of doxorubicin (DOX) and miR-54-3p for triple negative breast cancer (TNBC) therapy (abstract). Furthermore, Wang teaches hydrophobic Dox (page 418, left col., 1st paragraph), hyaluronic acid (HA)-decorated polyethyleneimine-poly)D,L-lactide-co-glycolide) (PEI-PLGA) nanoparticles dispersed as monodispersed particles with a well-defined spherical core-shell structure (page 414, right col., last paragraph). Therefore, the inventions do not contribute to a special technical feature when viewed over the prior art, or meet key critical elements, they do not have a single general inventive concept, thus the groups lack unity of invention and restriction between them is proper. The holding of lack of unity is maintained in its entirety.
In regards to motivation to combine references and pairwise of references, as noted in previous Office Action on pages 8 and 9, the reasonable expectation of success and motivation to combine has been established.
It has been held that combinations of two or more compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is to be used for the very same purpose. In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from their having been individually taught in prior art. Therefore, since each of the references teaches that the individual components of the core-shell nanoparticles composition comprising a graft polymer, wherein the graft polymer comprises lignin and PLGA that are covalently linked via ester bonding, it would have been obvious to combine them with the expectation that such a combination would also effective. Thus, combining them flows logically from their having been individually taught in prior art.
Applicant is arguing the cited references individually, and further arguing each rejection individually, rather than viewing the teachings of (1) Wang, (2) Liu, (3) Olsson, and (4) Makadia as a whole. Applicants are arguing the references individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). [T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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