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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg (US 2016/0167312), in view of Zavazava (WO 2015066705).
Claim 1, Feinberg teaches a method of fabricating an actuator for use in a marine environment comprising:
printing a body of the actuator from a biologically-derived hydrogel in a support bath using an additive manufacturing print head, FEINBERG, para [0051] discloses “any gelling biomaterial or organogel can be used as an ink. Depending on the ink, any reversible gel can be used as a support, for example, alginate gels, collagen gels, PNIPAAM, or an organogel,” and para [0050] discloses “A range of materials using FRESH have been 3D printed, including alginate, collagen, fibrin, matrigel” ;
wherein the support bath has a first concentration of a crosslinking initiator; FEINBERG, para [0053] discloses “which simultaneously provides additional crosslinking of the collagen and melts the gelatin.”;
incubating the body in a solution having a second concentration of a crosslinking initiator, FEINBERG does not explicitly teach this limitation; however, ZAVAZAVA, para [0269] discloses “the printed construct may be immersed in a calcium chloride solution to further crosslink and strengthen the structure.” ;
wherein the second concentration is greater than the first concentration; FEINBERG does not explicitly teach this limitation; however, ZAVAZAVA, para [0319] discloses “This can be explained by gelation process, which depends on crosslinker and alginate concentrations as well as the flow rate of crosslinker through the core section. Due to low Ca.sup.2+ concentration in 2% CaC¾ solution, only a small portion of the deposited alginate was crosslinked.”;
and removing the actuator body from the solution, ZAVAZAVA, para [0421] discloses “Upon fabrication conduits were soaked in 4% CaC¾ solution for 30 minutes to ensure sufficient crosslinking. Thereafter, conduits were dehydrated at room temperature for four days “ Feinberg teaches printing hydrogel (alginate) in a support bath containing calcium ions.Zavazava teaches post-print immersion in CaCl₂ to further crosslink and strengthen and that higher concentrations increase crosslink density, thus, It would have been obvious to a person of ordinary skill in the art to modify the primary reference by subjecting the printed hydrogel to a higher-concentration calcium solution after printing, as taught by the secondary reference, in order to increase mechanical strength and structural integrity, which is a known goal in hydrogel fabrication and marine environment is an intend use.
Claim 4, With respect to “wherein the crosslinking initiator comprises a CaCl2 solution,” FEINBERG, para [0049] discloses “FRESH uses a support bath material that enables biological hydrogels to be directly printed in 3D complexity using a range of soft biomaterials including alginate, collagen, hyaluronic acid, and fibrin” and ZAVAZAVA, para [0208] discloses “A sodium alginate solution was formed by dissolving 4% (w/v) sodium alginate
(Sigma Aldrich, United Kingdom) in deionized water, and a calcium chloride solution was formed by dissolving 4% (w/v) calcium chloride (CaC12) (Sigma Aldrich, Japan) in deionized water. These parameters were considered for material preparation due to structural integrity and acceptable cell viability in hybrid printed structures. Food dye (August Thomsen
Corporation, USA) was added to the alginate mixture for visualization purposes. Food dye was omitted for the cell viability studies disclosed herein. The crosslinking between the alginate solution and the calcium chloride solution formed the hydrogel. ” With respect to “and the first concentration is about 0.05%,” the cited references do not explicitly disclose this exact value, but ZAVAZAVA, para [0247] teaches variation of concentration as a result-effective variable. Thus, it would have been obvious to the ordinary skilled artisan to modify these references for the claimed invention.
Claim 5, With respect to “wherein the crosslinking initiator comprises a CaCl2 solution,” ZAVAZAVA, para [0269] discloses “A calcium chloride crosslinking solution was dispensed at a constant rate for 2 ml/min in all experiments.” With respect to “and the second concentration is about 2.5%,” ZAVAZAVA, para [0269] discloses “Direct crosslinking of the hanging alginate droplet on the nozzle tips was used as the control for all groups. 5-15 cm of printed tubular cell-laden channels was collected for each sample. Immediately after printing, each sample was kept in Hanks Balanced Salt Solution (HBSS) (Invitrogen™ Life Technologies, Carlsbad, CA) supplemented with 4% (w/v) calcium chloride for maintained crosslinking.”
Claim 6. With respect to “preparing the biologically-derived hydrogel by solubilizing sodium alginate in heated deionized water to a concentration of about 4% w/v,” ZAVAZAVA, para [0208] discloses “A sodium alginate solution was formed by dissolving 4% (w/v) sodium alginate (Sigma Aldrich, United Kingdom) in deionized water, and a calcium chloride solution was formed by dissolving 4% (w/v) calcium chloride (CaC12).”, thus its obvious within the knowledge of ordinary skilled artisan.
Claim 7, With respect to “wherein the body comprises a plurality of layers with a first printed layer and a final printed layer disposed on opposite ends of the body along a longitudinal axis,” FEINBERG, para [0064] discloses “The alginate was mixed with food coloring to aid visualization during the printing process and various time points (a)-(d) show the layer-by-layer fabrication..”
Claim 8, With respect to “wherein the first concentration is sufficient to allow adjacent layers of the plurality of layers to fuse prior to crosslinking,” FEINBERG, para [0068] discloses “Another example of a structure that can be printed using FRESH is a filament. FIG. 8 shows a fluorescence image 800 of an alginate filament 802 embedded among gelatin particles 804 at a scale of 1 mm. FIG. 9 shows a rectilinear pattern 900 of filaments 906 and fluorescence images 902 and 904 of the filaments 906 at a scale of 500 μm. FIG. 10 shows an octagonal pattern 1000 of filaments 1006 and fluorescence images 1002 and 1004 of the filaments 1006 at a scale of 500 μm.”
Claim 9, With respect to “wherein the body of the actuator is printed as a monolithic structure,” FEINBERG, para [0044] discloses “ Fused Deposition Modeling (FDM), but in FDM, material is deposited on top of a previously deposited layer, which provides the necessary mechanical support to build multiple layers”
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg (US 2016/0167312), in view of Zavazava (WO 2015066705), further in view of Fisher (US 2012/0122208).
Claim 2. With respect to “modifying a strength of crosslinking by adding a chelator after removing the actuator body from the solution,” FEINBERG and ZAVAZAVA do not explicitly teach this limitation; however, FISHER, para [0037] discloses “The size of the alginate beads may be selectively controlled by changing the size of the needle. The beads can then be dissolved through the addition of a calcium chelating agent such as ethyldiaminetetraacetic acid (EDTA) which sequesters the crosslinking calcium ions.”
Claim 3, With respect to “reversing an effect of the chelator by exposing the actuator body to a calcium solution,” FISHER, para [0037] discloses “ Alginate may be used as a scaffold because of its ability to be dissolved with a calcium chelating agent, and because of the ease of which it can be formed into spherical scaffolds. Alginate is composed of mannuronic acid and guluronic acid chains. When a divalent ion such as calcium is added to an alginate solution, the calcium binds between guluronic acid blocks of the alginate chain ionically crosslinking the alginate chains and gelling the alginate solution..”, thus it would have been obvious within the knowledge ordinary skilled artisan prior to the applicant’s earliest priority of date of the invention to modify both Feinberg and Zavazava with Fisher to come up with the claimed invention.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Filip (WO2012148472), in view of Feinberg (US 2016/0167312).
Claim 10. An actuator suitable for use in a marine environment comprising:
a body defining an internal chamber, FILIP, para [0014] discloses “The molded body in the soft body robotic device is configured to preferentially expand when the plurality of interconnected chambers are pressurized by the fluid” ;
wherein the body comprises a plurality of layers of biologically-derived hydrogel aligned along a longitudinal axis of the body, FEINBERG, para [0044] discloses “ Fused Deposition Modeling (FDM), but in FDM, material is deposited on top of a previously deposited layer, which provides the necessary mechanical support to build multiple layers” and para [0045] discloses “EFM can also be used to print biologically derived protein and/or polysaccharide hydrogels such as chitosan or Matrigel, synthetic hydrogels such as polyethylene glycol (PEG) based hydrogels, and other synthetic gel, elastomer and rigid polymers such as polydimethylsiloxane, polyurethanes, thermosets, coacervate solids, and foams..” ; and a plurality of bonds crosslinking adjacent layers of the plurality of layers to form a water-tight seal, FEINBERG, para [0039] discloses “The soft materials are printed inside a temporary support material that can be removed later by, e.g., heating or cooling the support material to dissolve or melt the support material, or removing cations to disrupt crosslinking of the support material. Additional techniques for removing the support material include vibration, irradiation with ultraviolet, infrared, or visible light, or application of a constant or oscillating electric or magnetic field..”, thus it would have been obvious to ordinary skilled artisan prior to applicant’s earliest priority date of this application to modify Filip with Feinberg to come up with the claimed invention.
Claim 11, With respect to “wherein a shape of the actuator is selected from a group consisting of: a pneumatic network actuator, a linear actuator, a twisting continuum actuator, and a combination of any of the foregoing,” FILIP, para [0012] discloses “Soft robotic actuators configured to perform new fundamental motions - such as bending, twisting, and straightening - are described. These and other aspects and embodiments of the disclosure are illustrated and described below..”
Claim 12, With respect to “excluding any non-biodegradable materials,” FEINBERG, para [0045] discloses “EFM can also be used to print biologically derived protein and/or polysaccharide hydrogels such as chitosan or Matrigel, synthetic hydrogels such as polyethylene glycol (PEG) based hydrogels, and other synthetic gel, elastomer and rigid polymers such as polydimethylsiloxane, polyurethanes, thermosets, coacervate solids, and foams.”
Claim 13, With respect to “further comprising a pressurized working fluid contained within the internal chamber of the body,” FILIP, para [0056] discloses “The method can also include providing sufficient pressure to the soft robotic device or the gripping device or the soft robot or the pressurizable network or the soft machine to cause a less stiff wall to expand preferentially.”
Claim 14, With respect to “a conduit providing a path for a working fluid from an external source to the internal chamber, wherein the conduit is disposed within an exterior surface of the body,” FILIP, para [0067] discloses “providing pressurized fluid to a first pressurizing inlet of the soft robot, and providing pressurized fluid to a second pressurizing inlet of the soft robot, thereby separately actuating a first arm associated with the first pressurizing inlet and a second arm associated with the second pressurizing inlet”
Claim 15, With respect to “wherein the biologically-derived hydrogel comprises alginate,” FEINBERG, para [0031] discloses the printed material may “para [0045] discloses “EFM can also be used to print biologically derived protein and/or polysaccharide hydrogels such as chitosan or Matrigel, synthetic hydrogels such as polyethylene glycol (PEG) based hydrogels, and other synthetic gel, elastomer and rigid polymers such as polydimethylsiloxane, polyurethanes, thermosets, coacervate solids, and foams”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUD AHMED whose telephone number is (571)270-1315. The examiner can normally be reached M-F 9:00-8:30 PM PST with IFP.
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MASUD . AHMED
Primary Examiner
Art Unit 3657A
/MASUD AHMED/Primary Examiner, Art Unit 3657
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