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 .
DETAILED ACTION
Pursuant to the amendment dated 12/08/2025, claims 9 and 15 are amended, claims 1-8 were cancelled and claims 18-20 are newly added. Claims 9-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims domestic benefit of U.S. Provisional Application No. 63/253,173, filed on October 7, 2021.
Withdrawn Objections
Applicant’s amendment, filed on 12/08/2025, with respect to the objections of 8 because of the following informalities: missing the word “in” in the phrase “being in a gel state a temperature ranging…” between the phrases “state” and “a”, has been fully considered and is persuasive. Applicant has canceled the claim rendering the objection moot. The objection is hereby withdrawn.
Applicant’s amendment, filed on 12/08/2025, with respect to the objections of 8 because of the following informalities: missing “°C” after the number 10 and missing the degree symbol after 60, has been fully considered and is persuasive. Applicant has canceled the claim rendering the objection moot. The objection is hereby withdrawn.
Withdrawn Rejections
Applicant’s amendment, filed on 12/08/2025, with respect to the rejection of claim 6 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, has been fully considered and is persuasive. Applicant has canceled claim 6 rendering the rejection moot. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 12/08/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Obaidat et al. (AAPS PharmSciTech, published 05/07/2018, see PTO-892 dated 03/21/2025).
has been fully considered and is persuasive. Applicant has canceled claim 1 rendering the rejection moot. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 12/08/2025, with respect to the rejection of claims 1-3, 5, 6 and 8 under 35 U.S.C. 103 as being unpatentable over Wu (US2014/0112964 Al, published 04/24/2014, see PTO-892 dated 08/25/2025) and as evidenced by Garrec et al. (Food Hydrocolloids, published 02/20/2013, see PTO-892 dated 08/25/2025) has been fully considered and is persuasive. Applicant has canceled independent claim 1 rending the rejection moot. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 12/08/2025, with respect to the rejection of claims 1 and 9-14 under 35 U.S.C. 103 as being unpatentable over Feinberg et al. (US 2016/0167312 A1, published June 16, 2016, see PTO-892 dated 03/21/2025), Wu (US2014/0112964 Al, published 04/24/2014, see PTO-892 dated 08/25/2025) and Sen et al. (Food Research International, published 03/26/2010, see PTO-892 dated 08/25/2025) has been fully considered and is persuasive. Applicant has canceled claim 1 rending the rejection moot. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 12/08/2025, with respect to the rejection of claims 15-17 under 35 U.S.C. 103 as being unpatentable over Feinberg et al. (US 2016/0167312 A1, published June 16, 2016, see PTO-892 dated 03/21/2025), Wu (US2014/0112964 Al, published 04/24/2014, see PTO-892 dated 08/25/2025) and Sen et al. (Food Research International, published 03/26/2010, see PTO-892 dated 08/25/2025) has been fully considered and is persuasive. Sen is drawn to bulk kappa carrageenan gels which do not necessarily have the same physical properties as kappa carrageenan particles. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 12/08/2025, with respect to the rejection of claim 4 under 35 U.S.C. 103 as being unpatentable over Feinberg et al. (US 2016/0167312 A1, published June 16, 2016, see PTO-892 dated 03/21/2025), Wu (US2014/0112964 Al, published 04/24/2014, see PTO-892 dated 08/25/2025) and Sen et al. (Food Research International, published 03/26/2010, see PTO-892 dated 08/25/2025) as applied to claim 1 above, and further in view of Bakht (Adv. Funct. Mater., published August 11, 2021, see PTO-892 dated 03/21/2025) has been fully considered and is persuasive. Applicant has canceled claim 1 to which claims 4 was dependent upon rending the rejection moot. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) necessitated by Applicants' amendment, filed on 12/08/2025, wherein instant independent claims 1 was canceled and instant independent claim 9 was amended to alter the breadth and scope of the claim, and wherein the remaining pending claims 10-20 depend from said independent claim.
New Grounds of Rejection
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.
Claims 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al. (US 2016/0167312 A1, published June 16, 2016, see PTO-892 dated 03/21/2025), Garrec et al. (Journal of Food Engineering, published 04/17/2012, see PTO-892, hereinafter referred to as Garrec 2012) and Garrec et al. (Food Hydrocolloids, published 02/20/2013 dated 08/25/2025, see PTO-892, hereinafter referred to as Garrec 2013).
Feinberg is drawn to a method of using a support material in which a structure was fabricated in the support material. The provided support material was configured to mechanically support at least a portion of the structure and to prevent deformation of the structure during the fabrication of the structure (abstract). Feinberg teaches that the support material, or support bath, may be composed of microparticles that act as a fluid during the print process and that the support material could act as a fluid during the printing process (paragraph 0049). Feinberg teaches that the support material may demonstrate a significant shear thinning behavior such that the support material acts like a solid material during deposition of the structure materials and then acts like a fluid when the nozzle is moved through the support material (paragraph 0040). Feinberg teaches that any reversible gel can be used as a support material (paragraph 0051). Feinberg discloses the method as a 3D printing technique referred to as Freeform Reversible Embedding of Suspended Hydrogels (FRESH) to enable the 3D printing of soft, biological hydrogel structures (paragraph 0048). Feinberg teaches that any gelling biomaterial or organogel can be used as an ink (paragraph 0051). The structure material may include at least one of a gel material that is different from the support material and may include at least one of an alginate material, a collagen material, a fibrin material, a hyaluronic acid material, a protein material, a polysaccharide hydrogel material, synthetic gel material, an elastomer polymer material, a rigid polymer material, or a polydimethylsiloxane (PDMS) elastomer. The method may include treating the structure material to cause the structure material to transition from the fluid to the solid or semi-solid state after the deposition of the structure material. (paragraph 0009). The support material can be combined with cell growth medium and gelling biopolymers such as collagen and fibrin can be printed with cells to effectively 3D print living tissues (paragraph 0073). Feinberg teaches that the printing was done at room temperature to keep the gelatin as a solid (paragraph 0060). Feinberg exemplified the use of gelatin slurry in the form of microparticles as a support material that was supplemented with CaCl2. Alginate scaffolds were then 3D printed within the support bath where the calcium ions crosslinked the alginate and the gelatin mechanically supported the alginate. Once the alginate scaffolds were printed, the gelatin was removed by heating the support material above its melting temperature of 37°C (paragraph 0052). Feinberg teaches that a wide range of materials can be used to create the support bath and teaches that ultra-low melting point agarose has a similar thermos-reversible characteristic to gelatin and thus can be melted at physiologic temperatures. Further, other forms of agarose with higher melting temperatures could be used for print materials with different thermal properties (paragraph 0054). Feinberg teaches that the process can be performed in a sterile aqueous, buffered environment compatible with cells to maintain cell viability and that the bath material used can have the thermo-reversible property to be melted at a cell-friendly 37°C (paragraph 0049). Feinberg teaches that cell suspensions may be embedded in the thermo-reversible support material (paragraph 0048).
Regarding instant claim 12, Feinberg exemplified the printing of a lumen in the support material (paragraph 0066).
Feinberg teaches that the FRESH 3D bioprinting had been utilized to print vascular networks and whole organs, which would meet the instant claim 13 limitation of printing a blood vessel (paragraph 0050).
Regarding claim 14, although Feinberg did not specifically claim that the lumen was surrounded by cells, Feinberg did teach that cells could be printed into a gelatin support material that was combined with cell growth medium to 3D print living tissues (paragraph 0073) and showed an example of C2C12 myoblasts in a collagen construct (Fig. 14).
Regarding claims 15 and 16, Feinberg teaches that the support slurry can be combined with cell growth medium (paragraph 0073). Feinberg exemplified the printing of cells into a gelatin support material that was combined with cell growth medium to 3D print living tissues incubated at least 24 hours (paragraph 0073) and exemplified C2C12 myoblasts in a collagen construct incubated over 7 days (Fig. 14). As Feinberg does not describe the removal of the gelatin before cell incubation and as the media must still have been present, it would be reasonable to conclude that the 3-demensional cell construct was grown within the support material.
Feinberg does not teach the hydrogel composition comprising kappa carrageenan with a concentration between 0.001% and 2%, wherein the water concentration is between 85% and 99%, and wherein the kappa carrageenan is in a form of spherical particles of average diameter of 1 µm to 100 µm.
Garrec 2012 is drawn to the study of kappa carrageenan fluid gel material properties (title). Garrec 2012 shows gelation temperature is dependent on the concentration of KCl with gelation temperatures of a 1% kappa carrageenan solution ranging from ~22°C at 0.1% KCl up to ~48°C at 0.6% KCl (page 176, Figure 1).
Garrec 2013 is drawn to the study of kappa carrageenan fluid gel material properties (title). Garrec 2013 teaches that kappa carrageenan at concentrations of 0.5%, 1%, and 2% with 0.3% KCl show shear thinning behavior over the concentration ranges and a broad range of volume fractions (page 154, column 2). The remaining solution was deionized water (page 152, column 1). The particle diameters were 0.97-1.36 um (Page 152, Table 1).
It would have been prima facie obvious to combine the teachings of Feinberg, Garrec 2012 and Garrec 2013 before the effective filing date of the claimed invention by
substituting the support bath material of Feinberg with the kappa carrageenan fluid gel
comprising 0.5-2% kappa carrageenan, potassium chloride as a crosslinker, shear thinning behavior as taught by Garrec 2013 and with a diameter of approximately 1 µm taught by Garrec 2012 to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to use the kappa carrageenan hydrogel taught by Garrec 2012 and Garrec 2013 as the supporting material in the process of Feinberg because Feinberg teaches that a polysaccharide hydrogel could be used as a supporting material. One of ordinary skill in the art would have a reasonable expectation of success because Feinberg teaches that a polysaccharide hydrogel could be used as a supporting material and Garrec 2012 and Garrec 2013 teach a kappa carrageenan micro gel comprising 0.5-2% kappa carrageenan, potassium chloride as a crosslinker, and with a diameter of approximately 1 µm.
Regarding instant claims 17, it would have been prima facie obvious to combine the teachings of Feinberg, Garrec 2012 and Garrec 2013 before the effective filing date of the claimed invention by optimizing the printing temperature taught by Fienberg to be between 30°C and 40°C to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the printing temperature to be between 30°C and 40°C because Fienberg teaches that the printing is done at a temperature wherein the supportive material is still a gel and Garrec 2012 teaches that kappa carrageenan is gel-state dominant from ~22°C at 0.1% KCl up to ~48°C at 0.6% KCl. One of ordinary skill in the art would have a reasonable expectation of success because the supportive material should be maintained as a gel as taught by Fienberg and Garrec 2012 teaches that kappa carrageenan is in a gel-state from ~22°C at 0.1% KCl up to ~48°C at 0.6% KCl. In the case where the claimed ranges “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). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature 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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Regarding instant claims 19, the combined teachings of Feinberg, Garrec 2012, and Garrec 2013 are silent about the Kcar granular hydrogel being in a gel state at the temperature ranging from 37°C to 60°C and having a light transparency of about 55% when measured at a wavelength between 400 and 700 nm. However, as these are physical properties that would be inherent of a Kcar hydrogel comprising 0.001 and 2% kappa carrageenan and crosslinked with KCl and with an average diameter of 1 micrometer to 100 micrometers as taught by Garrec 2012, the limitations are met by the teachings of Feinberg, Garrec 2012, and Garrec 2013 (see MPEP 2112).
In the case where the claimed ranges “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). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature 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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered in so much as they apply to the amended claims but they are not persuasive.
Applicant argues that Wu is irrelevant art as the Kcar granular hydrogel is in a form of spherical particles, i.e. consists of the spherical microparticles so that the claimed water content solely refers to the water entrapped inside the spherical particles. Applicant argues that Wu teaches hydrogel particles dispersed in an aqueous carrier wherein the instantly claimed Kcar granular hydrogel is devoid of carrier. The argument is not persuasive. The claim does not specify that all of the water is entrapped inside of the spherical particles and there is no direct teaching from the specification to define nor support the spherical microparticles of the hydrogel as having all the water entrapped within the microparticles. Therefore, any kappa carrageenan hydrogel consisting of 0.001 and 2% kappa carrageenan, KCl, and 85-99% water with a diameter between 1 µm to 100 µm would meet the limitations of instant claim 9.
Applicant argues that since the gelation temperature taught by Garrec 2013 is below the cell incubation temperature of 37°C, a skilled artisan would not be able to arrive at the instantly claimed support material. The argument is not persuasive. With the newly cited art to Garrec 2012 that shows that gelation temperature of kappa carrageenan is a function of the concentration of KCl, one of ordinary skill in the art would be able to adjust the concentration of the KCl within the parameters of the instantly claimed invention to obtain a kappa carrageen hydrogel that is a gel state within the printing temperature of 37°C. As Garrec 2012 teaches that the kappa carrageenan hydrogel’s gelation temperature may be adjusted by the concentration of KCl and Garrec 2013 teaches that the kappa carrageenan hydrogels have shear thinning behavior, the resulting kappa carrageenan hydrogels would meet the limitation of the instantly claimed hydrogel.
Applicant argues that the gelatin slurry taught by Feinberg is inferior to the kappa carrageenan hydrogel of the instant invention as the claimed support material substantially maintains their shape as opposed to the example of Feinberg wherein the gelatin slurry is immediately removed after printer and transferred to liquid medium. The argument is not persuasive as in the method taught by Feinberg, the printed structure did not necessarily be removed immediately. Feinberg exemplified C2C12 cells printed in Collagen I gel which were incubated for 7 days with no mention of the removal of the gelatin support slurry. Further, Feinberg teaches that other materials with shear thinning may be used as the support material including polysaccharides and materials with higher melting temperatures. Garrec 2012 and Garrec 2013 teach a kappa carrageenan hydrogel with shear thinning behavior that meets the limitations of the instantly claimed invention. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693