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 .
Formal Matters
Applicant’s claim amendments and arguments in reply filed on 10 march 2026 are acknowledged and have been fully considered. Claims 1-2, 4-17, 20-24, and 26-33 are pending. Claims 1-2, 4-17, 20, and 33 are under consideration in the instant office action. Claims 21-24 and 26-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Claims 3 and 25 are canceled. Applicant’s claim amendments and arguments did not overcome the rejections under 35 USC 103 set forth in the previous office action for reasons set forth below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
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 1-2, 4-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Green (WO2013086500, 6/13/2013; cited in Applicant IDS) in view of Moon (PloS one. 2012 Feb 6;7(2):e31472, 2/6/2012; cited in Applicant IDS) and Hu (Nanoscale Research Letters 2014, 9:434, 8/27/2014, cited in Applicant IDS).
Applicant Claims
Applicant claims a non-spherical biomimetic artificial cell as recited in amended claim 1. Dependent claims thereof recite other features that further limit the independent claim.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Green teaches a biomimetic artificial cell comprising a three-dimensional, asymmetrical nanoparticle (page 3, lines 25-29 and claim 1) and at least one biomolecule conjugated to the artificial cell (Example 9). The nanoparticle of the biomimetic artificial cell is formed from PLGA (Figures 2 and 3) and used as a biomimetic artificial antigen-presenting cell (abstract). With regard to claim 2, Green teaches in other embodiments, the presently disclosed subject matter provides an artificial antigen presenting cell (aAPC) comprising: (a) a three-dimensional microparticle or nanoparticle having an asymmetrical shape, wherein the asymmetrical shape has at least one surface having a radius of curvature along at least one axis which is in one of the following ranges: 1nm-1 mm (Green, page 4, lines 1-8). With regard to claims 4 and 5, the artificial cell has a prolate, tri-axial, or oblate ellipsoid shape (Green, page 4, lines 16-18). With regard to claims 6-8, as described above, the nanoparticle is made from PLGA and thus has degradable ester linkages. With regard to claim 9, the biodegradable polymer is blended with a nondegradable polymer (Green, page 13, line 30; page 14, lines 1-3). With regard to claim 10, the aspect ratio is 1.1-5 (Green, page 12, lines 24-25). With regard to claims 12-15, the biomolecule is streptavidin (Green, example 9). With regard to claim 17, Green teaches that shaped particles show reduced phagocytosis (page 3, lines 6-8). With regard to claim 20, Greene teaches the presently disclosed subject matter also provides kits comprising the aAPC. In general, the kits comprise aAPCs in an amount sufficient to treat at least one patient at least one time to modulate T cells in the patient. Typically, the aAPCs of the kit will be supplied in one or more container, each container containing a sufficient amount of particles for at least one dosing of the patient. In other embodiments, the presently disclosed subject matter includes a kit comprising the raw materials for making the presently disclosed aAPCs and the presently disclosed device for stretching the particles (see FIGS. 18A and 18B) (see page 16, lines 16-23).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.012)
Green does not teach the inclusion of a supported lipid bilayer and the limitations that are drawn to the SLB in claim 11 and the properties recited in claims 16-17. These deficiencies are cured by the teachings of Moon.
Moon teaches the formation of a supported lipid bilayer over a PLGA nanoparticle with a biomolecule conjugated to the supported lipid bilayer, where the resulting artificial cell is used for antigen presentation (abstract, Figure 1). Moon teaches that this type of structure is useful for mimicking the pathogen whose antigen is being presented (abstract). Lipid-enveloped PLGA NPs were synthesized by a W:O:W double-emulsion/solvent evaporation method, with PLGA and lipids (DOPC:DOPG:maleimide-headgroup phosphoethanolamine in a 4:1:5 mol ratio) co-dissolved in the organic phase. Self-assembly of lipid at the surface of each NP allowed subsequent conjugation of thiolated VMP001 to maleimide groups displayed in the lipid coating of the particle surfaces (Fig. 1A) (see results section page 3). With regard to claim 11, the biomolecule is found on the surface of the SLB (Moon, Figure 1A). With regard to claim 16, given that the SLB has the same asymmetrical shape claimed, which is considered to give rise to the lateral diffusive properties, it would retain lateral diffusive properties as compared to the SLB of a similar spherical biomimetic artificial cell.
Green and Moon do not teach how to actually prepare a supported lipid bilayer over the PLGA nanoparticle with an asymmetric shape, as the preparation method of Moon involves emulsification of the lipid components together with the dissolved PLGA to form the lipid-coated nanoparticles (Moon, page 2), whereas the particles of Green are stretched after formation to give them the asymmetric morphology (Example 2). These deficiencies are cured by the teachings of Hu.
Hu teaches that to provide a lipid bilayer-encapsulated nanoparticle similar to that of Moon (i.e., PLGA nanoparticles encapsulated in a lipid bilayer for the purpose of antigen presentation to stimulate an immune response; Figure 1 and abstract), the lipid bilayer is applied to nanoparticles by forming liposomes and fusing the liposomes with the nanoparticles with sonication (page 2).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious before the effective filing date of the instant application to modify the teachings of Green by coating the asymmetrical PLGA nanoparticle with the lipid bilayer because Moon teaches the formation of a supported lipid bilayer over a PLGA nanoparticle with a biomolecule conjugated to the supported lipid bilayer, where the resulting artificial cell is used for antigen presentation (abstract, Figure 1). One of ordinary skill in the art would have been motivated to do so because Moon teaches that this type of structure is useful for mimicking the pathogen whose antigen is being presented (abstract). Moon further teaches that lipid-enveloped PLGA NPs were synthesized by a W:O:W double-emulsion/solvent evaporation method, with PLGA and lipids (DOPC:DOPG:maleimide-headgroup phosphoethanolamine in a 4:1:5 mol ratio) co-dissolved in the organic phase. Self-assembly of lipid at the surface of each NP allowed subsequent conjugation of thiolated VMP001 to maleimide groups displayed in the lipid coating of the particle surfaces (Fig. 1A) (see results section page 3). Furthermore, in the case where the claimed ranges for particle size “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, generally differences in concentration or particle size will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is within the purview of the skilled artisan to optimize particle size. The skilled artisan would have had a reasonable expectation of success in combining the teachings of Green and Moon because both references are drawn to a biomimetic artificial cell. One of ordinary skill in the art would have had a reasonable expectation of success by coating the asymmetrical PLGA nanoparticle of Green with the lipid bilayer of Moon and then conjugate the biomolecule of Green to the SLB as taught by Moon to better address Green’s goal of providing a biomimetic artificial antigen-presenting cell. With regard to the limitations of claims 16-17 since the SLB coating is addressed by Moon and the combination teachings of Green and Moon met the claimed structure of instant claim 1 the properties recited in claims 16-17 would necessarily be there.
It would have been prima facie obvious before the effective filing date of the instant application to modify the teachings of Green and Moon by using the method of Hu to apply the lipid bilayer to the nanoparticles of Moon and Green because Hu teaches that to provide a lipid bilayer-encapsulated nanoparticle similar to that of Moon (i.e., PLGA nanoparticles encapsulated in a lipid bilayer for the purpose of antigen presentation to stimulate an immune response; Figure 1 and abstract), the lipid bilayer is applied to nanoparticles by forming liposomes and fusing the liposomes with the nanoparticles with sonication (page 2). One of ordinary skill in the art would have been motivated to do so because Hu teaches in the conclusion section that lipid-PLGA hybrid NPs with variable lipid compositions were constructed. As a potential antigen delivery system, lipid-PLGA NPs exhibited superior quality in comparison to PLGA NPs in terms of stability, antigen release, and particle uptake by DCs. The in vitro performance of lipid-PLGA NPs was highly influenced by the composition of the lipid layer, which dictates the surface chemistry of hybrid NPs. Hybrid NPs enveloped by lipids with more positive surface charges demonstrated higher stability, better controlled release of antigen, and more efficient uptake by DCs than particles with less positive surface charges. The results should provide basis for future design of lipid-PLGA hybrid NPs intended for antigen delivery. The skilled artisan would have had a reasonable expectation of success in combining the teachings of Green, Moon, and Hu because all of the references are drawn using particles for presentation of antigens.
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green (WO2013086500, 6/13/2013; cited in Applicant IDS) in view of Moon (PloS one. 2012 Feb 6;7(2):e31472, 2/6/2012; cited in Applicant IDS) and Hu (Nanoscale Research Letters 2014, 9:434, 8/27/2014, cited in Applicant IDS) as applied to claims 1-2, 4-17, and 20 above, and further in view of Liu et al. (Nature Communication, 5, 4182, 1-11, 2014, newly cited).
Applicant Claims
Applicant claims a non-spherical biomimetic artificial cell. Claim 33 recites the use of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC) and cholesterol to make the SLB.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Green, Moon, and Hu are described in detail above and are incorporated herein by reference.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.012)
Green, Moon, and Hu do not teach the combination of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC) and cholesterol to make the SLB. This deficiency is cured by the teachings of Liu.
Liu teaches nanoparticles coated with supported lipid bilayer comprising DOPC, cholesterol(4:4 molar ratio with DSPE-PEG) for drug delivery. Particles are spherical, with therapeutics (e.g. cisplatin prodrugs) loaded in the core. The NCPs were further coated with DOPC, cholesterol and DSPE-PEG2k in a 4:4:2 molar ratio to lead to self-assembled, asymmetric lipid bilayers via hydrophobic/ hydrophobic interactions between DOPA and DOPC/ cholesterol/DSPE-PEG2k. Importantly, the NCP core allows the use of a very high molar ratio (20 mol%) of DSPE-PEG2k without destabilizing the lipid bilayer. In comparison, liposomes become unstable when the PEG molar ratios exceed 5 mol%, and most of the currently developed or clinically used liposomes have B5 mol% of PEG in lipid composition, including DOXIL65, SPI-77 and Porphysome. As a result of the PEG coating at such a high molar ratio, NCPs 1P and 2P exhibit prolonged blood circulation times and enhanced deposition of the platin drugs in tumour tissues (see page 9). In summary, we have developed novel NCP-based nanotherapeutics that show significant and numerous advantages over existing systems. First, the self-assembly of NCPs is carried out under mild conditions without using specialized equipment, making the NCP synthesis highly scalable. Second, particle size and drug loading were found to be very consistent from batch to batch among the several hundreds of batches of NCP particles synthesized. Third, the NCP platform carries very high drug loadings, which not only minimizes the amount of excipients that are co-delivered but also alleviates the potential aggregation issue often encountered by particles with modest drug loadings. Fourth, a particle size of 30–50 nm and near-neutral surface charge are two of the most desirable characteristics for nanotherapeutics. Small particles have enhanced penetration within tumours16, whereas particles with near-neutral surface charge ranging (from 10 to þ 10 mV) can minimize nonspecific interactions with proteins, self-aggregation and phagocytosis. NCPs effectively avoid MPS uptakes to lead to long circulation times, which is a key prerequisite for passive targeting by the EPR effect. Fifth, we have shown that the excipients used in the NCPs are non-toxic and biocompatible. Sixth, the pegylated NCPs showed no burst release at the initial stage, thus preventing premature drug release before the particles reach tumour sites. Finally, the NCP has a built-in trigger release mechanism to further enhance drug deposition in tumours (page 9).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious before the effective filing date of the instant application to modify the teachings of Green, Moon, and Hu by coating utilizing 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC) and cholesterol to make the SLB because Liu teaches nanoparticles coated with supported lipid bilayer comprising DOPC, cholesterol(4:4 molar ratio with DSPE-PEG) for drug delivery. Particles are spherical, with therapeutics (e.g. cisplatin prodrugs) loaded in the core. One of ordinary skill in the art would have been motivated to do so because Liu teaches the NCPs were further coated with DOPC, cholesterol and DSPE-PEG2k in a 4:4:2 molar ratio to lead to self-assembled, asymmetric lipid bilayers via hydrophobic/ hydrophobic interactions between DOPA and DOPC/ cholesterol/DSPE-PEG2k. Importantly, the NCP core allows the use of a very high molar ratio (20 mol%) of DSPE-PEG2k without destabilizing the lipid bilayer. In comparison, liposomes become unstable when the PEG molar ratios exceed 5 mol%, and most of the currently developed or clinically used liposomes have B5 mol% of PEG in lipid composition, including DOXIL65, SPI-77 and Porphysome. As a result of the PEG coating at such a high molar ratio, NCPs 1P and 2P exhibit prolonged blood circulation times and enhanced deposition of the platin drugs in tumour tissues (see page 9). In summary, we have developed novel NCP-based nanotherapeutics that show significant and numerous advantages over existing systems. First, the self-assembly of NCPs is carried out under mild conditions without using specialized equipment, making the NCP synthesis highly scalable. Second, particle size and drug loading were found to be very consistent from batch to batch among the several hundreds of batches of NCP particles synthesized. Third, the NCP platform carries very high drug loadings, which not only minimizes the amount of excipients that are co-delivered but also alleviates the potential aggregation issue often encountered by particles with modest drug loadings. Fourth, a particle size of 30–50 nm and near-neutral surface charge are two of the most desirable characteristics for nanotherapeutics. Small particles have enhanced penetration within tumours16, whereas particles with near-neutral surface charge ranging (from 10 to þ 10 mV) can minimize nonspecific interactions with proteins, self-aggregation and phagocytosis. NCPs effectively avoid MPS uptakes to lead to long circulation times, which is a key prerequisite for passive targeting by the EPR effect. Fifth, we have shown that the excipients used in the NCPs are non-toxic and biocompatible. Sixth, the pegylated NCPs showed no burst release at the initial stage, thus preventing premature drug release before the particles reach tumour sites. Finally, the NCP has a built-in trigger release mechanism to further enhance drug deposition in tumours (page 9). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) The skilled artisan would have had a reasonable expectation of success in combining the teachings of Green, Moon, Hu, and Liu because all of the references are drawn microparticles and nanoparticles and their use for the delivery of agents.
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 10 March 2026 have been fully considered but they are not persuasive.
Applicant argues Hu discloses a spherical particle. See Hu, FIG. 1B, and page 5, right column, 1st full paragraph. Applicant respectfully submits that the Office has not articulated any evidence that the necessary modifications to Green and Moon by Hu would have been routine, so there would have been no reasonable expectation of success. See MPEP § 2143, Example 10, discussing Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 90 USPQ2d 1947 (Fed. Cir. 2009). To this end, Applicant notes that according to MPEP § 2143.02, obviousness requires a reasonable expectation of success. MPEP § further provides that "[t]he reasonable expectation of success requirement refers to 'the likelihood of success' in combining or modifying prior art disclosures to meet the limitations of the claimed invention." Applicant respectfully submits that one of ordinary skill in the art would not have a reasonable expectation of success in modifying Green and Moon with Hu to obtain the non-spherical biomimetic artificial cell comprising a three-dimensional microparticle or nanoparticle having a supported lipid bilayer (SLB) coated on the three-dimensional microparticle or nanoparticle, wherein the SLB is evenly distributed across a surface of the three-dimensional microparticle, or nanoparticle as recited in claim 1 as currently amended. Accordingly, Applicant respectfully submits that claim 1 as currently amended is patentable over Green in view of Moon and Hu. As claims 2, 4-17, and 20 ultimately depend from claim 1 and incorporate all of the subject matter recited therein, claims 2, 4-17, and 20 are patentable over Green in view of Moon and Hu, as well.
The above assertions are not found persuasive because the non-spherical biomimetic artificial cell part of the limitation is clearly met by the teachings of Green. Green teaches a biomimetic artificial cell comprising a three-dimensional, asymmetrical nanoparticle (page 3, lines 25-29 and claim 1) and at least one biomolecule conjugated to the artificial cell (Example 9). The nanoparticle of the biomimetic artificial cell is formed from PLGA (Figures 2 and 3) and used as a biomimetic artificial antigen-presenting cell (abstract). With regard to claim 2, Green teaches in other embodiments, the presently disclosed subject matter provides an artificial antigen presenting cell (aAPC) comprising: (a) a three-dimensional microparticle or nanoparticle having an asymmetrical shape, wherein the asymmetrical shape has at least one surface having a radius of curvature along at least one axis which is in one of the following ranges: 1nm-1 mm (Green, page 4, lines 1-8). With regard to claims 4 and 5, the artificial cell has a prolate, tri-axial, or oblate ellipsoid shape (Green, page 4, lines 16-18). With regard to claims 6-8, as described above, the nanoparticle is made from PLGA and thus has degradable ester linkages. With regard to claim 9, the biodegradable polymer is blended with a nondegradable polymer (Green, page 13, line 30; page 14, lines 1-3). With regard to claim 10, the aspect ratio is 1.1-5 (Green, page 12, lines 24-25). With regard to claims 12-15, the biomolecule is streptavidin (Green, example 9). With regard to claim 17, Green teaches that shaped particles show reduced phagocytosis (page 3, lines 6-8). With regard to claim 20, Greene teaches the presently disclosed subject matter also provides kits comprising the aAPC. In general, the kits comprise aAPCs in an amount sufficient to treat at least one patient at least one time to modulate T cells in the patient. Typically, the aAPCs of the kit will be supplied in one or more container, each container containing a sufficient amount of particles for at least one dosing of the patient. In other embodiments, the presently disclosed subject matter includes a kit comprising the raw materials for making the presently disclosed aAPCs and the presently disclosed device for stretching the particles (see FIGS. 18A and 18B) (see page 16, lines 16-23). Hu is incorporated in the rejection to remedy the deficiency of Green and Moon on how to actually prepare a supported lipid bilayer over the PLGA nanoparticle with an asymmetric shape, as the preparation method of Moon involves emulsification of the lipid components together with the dissolved PLGA to form the lipid-coated nanoparticles (Moon, page 2), whereas the particles of Green are stretched after formation to give them the asymmetric morphology (Example 2). These deficiencies are cured by the teachings of Hu. Hu teaches that to provide a lipid bilayer-encapsulated nanoparticle similar to that of Moon (i.e., PLGA nanoparticles encapsulated in a lipid bilayer for the purpose of antigen presentation to stimulate an immune response; Figure 1 and abstract), the lipid bilayer is applied to nanoparticles by forming liposomes and fusing the liposomes with the nanoparticles with sonication (page 2). It would have been prima facie obvious before the effective filing date of the instant application to modify the teachings of Green and Moon by using the method of Hu to apply the lipid bilayer to the nanoparticles of Moon and Green because Hu teaches that to provide a lipid bilayer-encapsulated nanoparticle similar to that of Moon (i.e., PLGA nanoparticles encapsulated in a lipid bilayer for the purpose of antigen presentation to stimulate an immune response; Figure 1 and abstract), the lipid bilayer is applied to nanoparticles by forming liposomes and fusing the liposomes with the nanoparticles with sonication (page 2). One of ordinary skill in the art would have been motivated to do so because Hu teaches in the conclusion section that lipid-PLGA hybrid NPs with variable lipid compositions were constructed. As a potential antigen delivery system, lipid-PLGA NPs exhibited superior quality in comparison to PLGA NPs in terms of stability, antigen release, and particle uptake by DCs. The in vitro performance of lipid-PLGA NPs was highly influenced by the composition of the lipid layer, which dictates the surface chemistry of hybrid NPs. Hybrid NPs enveloped by lipids with more positive surface charges demonstrated higher stability, better controlled release of antigen, and more efficient uptake by DCs than particles with less positive surface charges. The results should provide basis for future design of lipid-PLGA hybrid NPs intended for antigen delivery. The skilled artisan would have had a reasonable expectation of success in combining the teachings of Green, Moon, and Hu because all of the references are drawn using particles for presentation of antigens.
Hu is simply exemplifying application of SLB on spherical microparticle or nanoparticle. The application is not limited to spherical particles. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Furthermore, Applicant’s claim does not exclude spherical shapes. Applicant even recite “wherein the non-spherical biomimetic artificial cell has an asymmetrical shape that can
relax to a spherical shape or non-spherical shape wherein (a), (b), and (c) are approximately equal.” Additionally, Hu on page 9 teaches that The morphology of NPs was studied using TEM. Consistent with the particle size measured using dynamic light scattering(DLS)(Table1),both PKNPs(Figure1C) and LPKNPs (Figure 1D) displayed a highly uniform particle size (around 200nm) and narrow size distribution. Most of the NPs showed a smooth surface and were of a spherical shape. Compared to PKNPs, there is a gray membrane covering LPKNPs (Figure 1D), demonstrating the successful hybridization of PKNPs and liposomes. The thickness of the membrane is around 20nm,which is equal to the thickness of a lipid bilayer. Applicant failed to articulate why the teachings of HU would not be useful to Green.
Conclusion
No claim is 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.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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