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 .
Summary
Claims 1-2 and 4-21 are pending in this office action. Claim 21 is new. Claim 3 is cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on May 16, 2023, which in turn claims domestic priority to provisional patent 63/343,655 filed on May 19, 2022.
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 11 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 11 is dependent on claim 3 which is cancelled. Therefore, claim 11 is unclear and indefinite.
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 non-obviousness.
Claims 1-2, and 4-21 are rejected under 35 U.S.C. 103 as being unpatentable over Thayumanavan et al. (US2020/0332047A1) in view of Zhang et al. (WO2017/120342A1), Lee (US11110127B2), Lee et al. (US2020/0405884A1), and Thayumanavan (US2019/0209698A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Thayumanavan et al. ‘047
Thayumanavan et al. ‘047 is considered the closest prior art as it teaches lipid-polymer based complexation and delivery of nucleic acids (see title). Furthermore, Thayumanavan et al. ‘047 disclose that the invention provides novel polymers, crosslinked polymer-nucleic acid complexes, lipid-polymer-nucleic acid-based
complexation and nanoassemblies, and nanoassembly-based intracellular delivery of nucleic acids and controlled release thereof upon degradation of the nanoassemblies
in response to specific microenviromnent in the cell, and compositions and methods of preparation and use thereof (see abstract).
2. Zhang et al.
Zhang et al. teach cellular or viral membrane coated nanostructures and uses thereof (see title). In addition, Zhang et al. disclose that the present invention relates to viral or cellular membrane coated nanostructures. Nanostructure networks, nanoscaffolds and articles of manufacture comprising the nanostructure, and uses thereof, are also provided. The present invention also relates to methods for anchoring, attaching and/or growing a target cell. Target cells, constituent(s) of the target cells, target substances made by the target cells or culture medium of the target cells prepared by the present methods, and uses thereof, are also provided (see abstract).
3. Lee ‘127
Lee ‘127 teaches use of nanoparticles coated with red blood cell membranes to treat hemolytic diseases and disorders (see title). Additionally, Lee ‘127 discloses that the present invention relates to methods, combinations and pharmaceutical compositions for treating or preventing a hemolytic disease or condition in a mammal, wherein: said hemolytic disease or condition is caused by an attack of said
mammal's red blood cells by said mammal's own body, or said mammal is a pregnant mammal and said hemolytic disease or condition of a fetus of said pregnant mammal is
caused by an attack of said fetus' red blood cells by an antibody of said pregnant mammal, or said mammal is a baby and said hemolytic disease or condition of said baby is caused by an attack of said baby's red blood cells by an antibody of said baby's mother. The exemplary hemolytic diseases or conditions include hemophagocytic lymphohistiocytosis, an autoimmune disease or condition, or a hereditary hemolytic disease or disorder (see abstract).
4. Lee et al. ‘884
Lee et al. ‘884 teach CRISPR-nanoparticles and methods of use in brain disorders (see title). Also, Lee et al. ‘884 disclose compositions and methods for treating
diseases and disorders of the brain using a non-viral nanoparticle delivery of CRISPR. Disclosed herein are compositions comprising CRISPR-Gold compositions comprising
DNA oligonucleotides, RNA-directed nucleases and guide RNAs. The methods include modulating expression of a gene in a cell using said compositions, inducing site-specific
DNA cleavage in a cell, and treating a subject having fragile X syndrome caused by increased metabotropic glutamate receptor 5 signaling using the compositions disclosed
herein (see abstract).
5. Thayumanavan ‘698
Thayumanavan ‘698 teaches polymeric nanoparticles and derivatives thereof for nucleic acid binding and delivery (see title). Furthermore, Thayumanavan ‘698 disclose that the invention provides polymers and polymeric nanogels in which nucleic acid molecules can be stably entrapped or encapsulated and are controllably delivered and released upon degradation of the nano-structures in response to specific microenvironment triggers, and compositions and methods of preparation and use thereof (see abstract).
Combination of Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127
Regarding instant claim 1, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach a polymer nanoparticle. The necessary citations of Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 Citations
A polymer nanoparticle comprising a crosslinked polymer complex comprising
Thayumanavan et al. ‘047 disclose a lipid decorated siRNA-polymer (L-siP) nanoparticle (see paragraph [0201] within Thayumanavan et al. ‘047). Furthermore, Thayumanavan et al. ‘047 disclose a crosslinked polymer-nucleic acid complex (see claim 14 within Thayumanavan et al. ‘047).
a cargo encapsulated in a crosslinked polymer network; and a coating on the crosslinked polymer complex,
Thayumanavan et al. ‘047 disclose a molecular assembly, comprising a crosslinked polymer-nucleic acid (cargo) complex comprising a nucleic acid encapsulated in a crosslinked polymer network; and a coating on the crosslinked polymer-nucleic acid complex (see claim 32 within Thayumanavan et al. ‘047).
wherein the coating is derived from a cellular membrane.
Thayumanavan et al. ‘047 disclose a zwitterionic lipid and a PEGylated lipid used for the coating (see claim 32 within Thayumanavan et al. ‘047).
Zhang et al. disclose the nano structure (nanoparticles; see abstract and paragraphs [0007] and [00022] within Zhang et al.), wherein the cellular membrane is derived from a tumor cell, a cancer cell, an immune cell, a stem cell, an endothelial cell, a b-cell, an exosome, a secretory vesicle or a synaptic vesicle (see claim 23 within Zhang et al.).
Additionally, Lee ‘127 discloses the use of red blood cell membranes to coat their nanoparticles (see title and abstract within Lee ‘127).
Motivation to combine
The use of cell membranes to cloak synthetic nanoparticles through a top-down
fabrication method has emerged as a promising technique for nanomaterial surface
functionalization. Such cloaking technique bestows nanoparticles with complex cell
surface properties and functions that are otherwise difficult to replicate. Currently, a
variety of cell membrane-coated nanoparticle systems have been developed with unique
features and functions, which involve different cell types (e.g., red blood cell, platelet,
leukocyte, cancer cell and bacterium) and different synthetic nanoparticles (e.g., polymeric nanoparticle, gold nanoparticle, and silica nanoparticle). These biomimetic
nanoparticles have demonstrated a wide range of biomedical applications including drug
delivery, photodynamic therapy, detoxification, and vaccination. However, the cell
membrane cloaking technique has not been generalized from spherical nanoparticles to
spidery nanofibers, which exhibit aspect ratios drastically different from nanoparticles. (see paragraph [0004] within Zhang et al.).
Therefore, a skilled artisan (POSITA; person having ordinary skill in the art) would use the Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 references to teach every element of instant claim 1.
The remaining instant claims within this 35 U.S.C. § 103 section are either directly or indirectly dependent on instant claim 1 and are taught in full by the combination of Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127.
Regarding instant claim 2, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein the crosslinked polymer complex comprises:
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Thayumanavan et al. ‘047 disclose the crosslinked polymer complex and nearly identical substituents (see claim 14 within Thayumanavan et al. ‘047). The major difference being the entrapped “cargo” of the present application which is a nucleic acid (siRNA) within Thayumanavan et al. ‘047 (see title and abstract within Thayumanavan et al. ‘047) and of a broader scope with the present application. Additionally, Thayumanavan et al. ‘047 disclose the crosslinked polymer complex and nearly identical substituents (see claim 15 within Thayumanavan et al. ‘047).
Regarding instant claim 4, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein X comprises a crosslinked group or a group capable of forming a crosslinking bond. Thayumanavan et al. ‘047 disclose that X is equal to a crosslinking moiety (see instant claim 2). Additionally, Thayumanavan et al. ‘047 disclose that a crosslinking moiety refers to a chemical moiety that is either capable of forming a crosslinking bond or is a chemical moiety that is crosslinked, either within the same polymer molecule or between different polymer molecules (see paragraph [0099] within Thayumanavan et al. ‘047).
Regarding instant claims 5-7, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein the cargo encapsulated in the crosslinked polymer matrix comprises a hydrophobic molecule, a nucleic acid, a protein, an antibody, or a combination thereof. Thayumanavan et al. ‘047 disclose the cargo as a nucleic acid (see title and abstract within Thayumanavan et al. ‘047). Lee ‘127 discloses other active ingredients which can encompass hydrophobic molecules, a protein, and an antibody (see column 17, line 28 through column 18, line 12 within Lee ‘127). Lee ‘127 further discloses these other active ingredients can be delivered in the form of a nanoparticle (see column 21, lines 11-28 within Lee ‘127). Therefore, a skilled artisan (POSITA) would combine any of the above “actives” for the purpose of delivering the desired “actives” of choice.
Also, Thayumanavan et al.’047 disclose the term "nucleic acid" refers to polymeric forms of nucleotides, including ribonucleotides as well as deoxyribonucleotides, of any length. They can include both double-, single-stranded or triple helical sequences and include, but are not limited to, cDNA from viral, prokaryotic, and eukaryotic sources; mRNA; genomic DNA sequences from viral (e.g., DNA viruses and retroviruses) or prokaryotic sources; RNAi; cRNA; antisense molecules; recombinant polynucleotides; ribozymes; and synthetic DNA sequences. The term also captures sequences that include any of the known base analogs of DNA and RNA. Nucleotides can be referred to by their commonly accepted single-letter codes. Exemplary nucleic acid molecules include double-stranded RNA (dsRNA), small interfering RNA (siRNA), messenger RNA (mRNA), non-coding RNA (ncRNA), microRNA, catalytic RNA, guide RNA (gRNA), DNAs, oligonucleotides, aptamers, genes, plasmids, and derivatives or analogs thereof (see paragraph [0072] within Thayumanavan et al. ‘047).
Regarding instant claim 10, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein W comprises a C1-30 linear or branched alkyl group. Thayumanavan et al. ‘047 disclose W as a hydrophobic group (see instant claim 2). Thayumanavan et al. ‘047 further defines W is a group that comprises hydrophobic groups, such as hydrocarbons that include -CH2- chains and rings. These substances lack the ability to hydrogen bond and their surface free energy is relatively low hence making them hydrophobic. In certain embodiments, W comprises a C1-30 linear, branched or cyclic alkyl group (see paragraph [0097] within Thayumanavan et al. ‘047).
Regarding instant claim 11, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein each of L1, L2, and L3 is independently an ester (-(C=O)O-) or an amide (-(C=O)NH-) linking group. Thayumanavan et al. ‘047 disclose that in certain embodiments, each of L1, L2, and L3 is independently an ester (-(C=O)O-) or an amide (-(C=O)NH-) linking group (see paragraph [0098] within Thayumanavan et al. ‘047).
Regarding instant claim 12, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein X comprises a group of the formula
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Thayumanavan et al. ‘047 disclose the crosslinked polymer complex and nearly identical substituents (see claim 26 within Thayumanavan et al. ‘047).
Regarding instant claim 14, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein the polymer nanoparticle is crosslinked intermolecularly and intramolecularly. Thayumanavan et al. ‘047 disclose the polymer nanoparticle is crosslinked intermolecularly and intramolecularly (see claim 28 within Thayumanavan et al. ‘047).
Regarding instant claim 15, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein the polymer nanoparticle is adapted to de-crosslink partially or completely upon contact with a biological or chemical stimulus. Thayumanavan et al. ‘047 disclose wherein the polymer nanoparticle is adapted to de-crosslink partially or completely upon contact with a biological or chemical stimulus (see claim 29 within Thayumanavan et al. ‘047).
Regarding instant claim 16, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein X comprises a pH-sensitive functional group or a redox-sensitive functional group. Thayumanavan et al. ‘047 disclose wherein X comprises a pH-sensitive functional group or a redox-sensitive functional group (see claims 30-31 within Thayumanavan et al. ‘047).
Regarding instant claims 17 and 18, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach wherein the coating is derived from a human cell, an animal cell, or a plant cell. Zhang et al. disclose the nano structure (nanoparticles; see abstract and paragraphs [0007] and [00022] within Zhang et al.), wherein the cellular membrane is derived from a tumor cell, a cancer cell, an immune cell, a stem cell, an endothelial cell, a b-cell, an exosome, a secretory vesicle or a synaptic vesicle (see claim 23 within Zhang et al.). The cell membrane coating is derived from human or animal cells.
Regarding instant claim 19, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach a method of making the polymer nanoparticle of claim 1, the method comprising: contacting an amphiphilic polymer and a cargo molecule to form a polymer complex; crosslinking the polymer to form a crosslinked polymer network entrapping the cargo molecule therein; and contacting the crosslinked polymer complex with a cell under conditions effective to provide the coating derived from a cellular membrane. Thayumanavan et al. ‘047 disclose a method for forming a molecular assembly,
comprising: mixing an amphiphilic polymer and a nucleic acid to form a polymer-nucleic acid complex; crosslinking the polymer in the polymer-nucleic acid complex to form a
crosslinked polymer network entrapping the nucleic acid therein; and contacting the crosslinked polymer-nucleic acid complex with a zwitterionic lipid and a PEGylated lipid to form a coating on the crosslinked polymer-nucleic acid complex, wherein the coating comprises the zwitterionic lipid and the PEGylated lipid (see paragraph [0180] within Thayumanavan et al. ‘047). This outlined method can be modified under standard conditions substituting the appropriate cargo for the disclosed nucleic acid, and substituting the coating to incorporate the RBC derived cellular membranes of both Chung and Lee ‘127.
Regarding instant claim 20, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach a method for delivering a cargo, the method comprising: administering the polymer nanoparticle of claim 1 to a subject in need of therapy. Thayumanavan et al. ‘047 disclose directing the molecular assembly to a target site comprises administering the molecular assembly to a subject in need thereof thereby releasing the entrapped nucleic acid molecules at the target site (see paragraph [0185] within Thayamanavan et al. ‘047). Additionally, Lee ‘127 administer their nanoparticles to deliver a therapeutic response (see column 19, lines 8-14 within Lee ‘127).
Regarding instant claim 21, Thayumanavan et al. ‘047, Zhang et al., and Lee ‘127 teach a polymer nanoparticle comprising a crosslinked polymer complex comprising a cargo encapsulated in a crosslinked polymer network; and a coating on the crosslinked polymer complex, wherein the coating is derived from a native cellular membrane of a tumor cell, a cancer cell, an immune cell, a stem cell, a neuronal cell, an epithelial cell, or an endothelial cell. Please see the discussion and citations within instant claim 1 for the necessary rejection text.
Combination of Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, and Lee et al. ‘884
Regarding instant claims 8 and 9, Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, Lee et al. ‘884 teach wherein the cargo comprises a protein comprising a CRISPR-associated protein. Lee et al. ‘884 disclose the terms Cas enzyme, CRISPR enzyme, CRISPR protein Cas protein and CRISPR Cas are generally used interchangeably and can refer to Cas9 and/or Cpfl proteins (see paragraph [0047] within Lee ‘884). Additionally, Lee et al. ‘884 disclose herein is a non-viral Cas9 delivery vehicle, termed CRISPR-Gold, to deliver the RNA-guided endonucleases Cas9 and Cpfl into the brains of adult mice and perform gene editing using Thy l-YFP and Ai9 mice (see paragraph [0052] within Lee ‘884). Moreover, the CRISPR-Gold composition can include an additional nucleic acid (see paragraphs [0045, 0057, 0059, 0063] within Lee ‘884). Therefore, a skilled artisan (POSITA) would incorporate a CRISPR-associated protein and a nucleic acid.
Motivation to add this limitation would be to expand the biological therapy of the nanoparticles of instant claim 1 to include gene editing.
Combination of Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, and Thayumanavan ‘698
Regarding instant claim 13, Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, Thayumanavan ‘698 teach wherein the crosslinked polymer network comprises a copolymer of Formula (IV)
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Thayumanavan et al. ‘047 disclose the crosslinked polymer (hydrogen not methyl backbone) complex and nearly identical substituents (see claim 27 within Thayumanavan et al. ‘047). Thayumanavan et al. ‘047 does not seem to disclose the definition of i, j, and k. However, Thayumanavan ‘698 disclose each of i and j is independently a positive number, and k may be zero or a positive number (see paragraph [0126] within Thayumanavan ‘698). Thus, meeting the claim limitation. It is believed this definition for i, j, and k would be the same for Thayumanavan et al. ‘047. The copolymer of Formula IV is not inventive by modifying the polymer backbone chain with a C1 alkyl group (methyl). That is the main difference between this copolymer and that disclosed within Thayumanavan et al. ‘047.
Analogous Art
The Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 references are directed to the same field of endeavor as the instant claims, that is, a polymer nanoparticle comprising a crosslinked polymer complex comprising a cargo encapsulated in a crosslinked polymer network; and a coating on the crosslinked polymer complex, wherein the coating is derived from a cellular membrane.
Obviousness
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 modify the lipid-polymer based complex disclosed by Thayumanavan et al. ‘047, using the teachings of Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 to incorporate the necessary claim limitations. Starting with Thayumanavan et al. ‘047, the skilled person only had to try the necessary claim limitations disclosed by Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698. The combination of Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 would allow one to arrive at the present application without employing inventive skill. This combination of the lipid-polymer based complex taught by Thayumanavan et al. ‘047 along with the use of the necessary claim limitations taught by Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the lipid-polymer based complex disclosed by Thayumanavan et al. ‘047 with the use of the necessary claim limitations taught by Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698. This combined modification would have led to an enhanced polymer nanoparticle that would be beneficial for patients.
In the context of instant method claims 19-20 the desired purpose defines an effect that arises from and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to claims 1-18 and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Response to Arguments
Applicant's arguments filed October 8, 2025 have been fully considered but they are not persuasive.
The Applicant’s claim amendments were sufficient to address the claim objections and the 35 U.S.C. §112 rejections, except for claim 11. Therefore, the claim objections (claim 12) and the 35 U.S.C. §112 rejections (4 and 12) from the Non-Final Rejection dated July 15, 2025 are withdrawn from the record.
The Applicant’s claim amendments did necessitate a new ground of rejection with the removal of the Chung citation and the addition of the Zhang et al. reference.
Applicant Argument: The Applicant argues that the claim limitation wherein the coating is derived from a cellular membrane is not met within instant claim 1.
Examiner’s Rebuttal: Since this is a 35 U.S.C. §103 rejection the Examiner is not relying on one reference to teach all the elements of instant claim 1. The Applicant amended claim 18 to delete where the coating is derived from a red blood cell cellular membrane. This prompted the Examiner to delete the Chung citation, and add the Zhang et al. reference wherein the cellular membrane is derived from a tumor cell, a cancer cell, an immune cell, a stem cell, an endothelial cell, a b-cell, an exosome, a secretory vesicle or a synaptic vesicle (see claim 23 within Zhang et al.). Therefore, the Zhang et al. reference supplies the coating of a cellular membrane, and all claim limitations of instant claim 1 and 18 are met.
Applicant Argument: The Applicant argues that 35 U.S.C. §103 rejection is not proper.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 references all have considerable overlap with a polymeric nanoparticle. In this instance, Thayumanavan et al. ‘047 supplies the lipid-polymer based complexation and delivery of nucleic acids as it relates to nanoparticles, Zhang et al. and Lee ‘127 disclose the cellular membrane coating as applied to nanoparticles, while Lee et al. ‘884, and Thayumanavan ‘698 supply claim specific examples pertaining to the polymeric nanoparticles. All references are directed to the treatment of various disease states and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the five references when seeking to improve or adapt a polymeric nanoparticle with cellular membrane derived coating.
Incorporating the disclosure of Thayumanavan et al. ‘047 into the polymeric nanoparticle having a cellular membrane derived coating presented in part or in whole by Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 would have been viewed by a POSITA as routine design optimizations or known modifications to synthesize to polymeric nanoparticle of the present invention. Implementing these features in Thayumanavan et al. ‘047’s lipid-polymer based complexation and delivery of nucleic acids would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Thayumanavan et al. ‘047, Zhang et al., Lee ‘127, Lee et al. ‘884, and Thayumanavan ‘698 provides all the elements of the claimed invention. The resulting polymeric nanoparticle containing a coating derived from a cellular membrane constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Applicant Argument: The Applicant argues that the Examiner is using impermissible hindsight in reverse engineering the invention of the instant application.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Examiner respectfully submits that 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).
Therefore, the 35 U.S.C. §103 rejection is maintained for instant claims 1-2 and 4-21.
Conclusion
No claims are allowed.
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.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615