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
Claims 14-20 withdrawn
Claims 1-2, 6, 9-12 amended
Claims 1-13 pending
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.
Claim(s) 1-2, 6-7, 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Aizenberg (PG Pub 2011/0192233 A1) in view of Lewis (PG Pub 2016/0346997 A1).
Consider Claim 1, Aizenberg teaches the process of forming negative mold replica (abstract), teaches the using of mold (102) (figure 1A, [0167]), and teaches casting the polymer that is curable (106) over the mold (102) (figure 1B, [0169]-[0170]), and where the curable polymer (crosslinking) include Alginates (hydrogels) [0170] and curing the alginate/hydrogel negative replica mold using heating/UV [0169], creating crosslinked hydrogel negative mold having a negative relief of mold. Aizenberg does no teach the presence of any type of inhibition molecules/materials. Leading to Aizenberg teaches the absent of inhibition process from any small molecules that is released from the mold and a surface of mold. Aizenberg teaches the removal of the cured/crosslinked alginate/hydrogel negative replica mold (108) from the mold (102) (figure 1B, [0170]). Aizenberg teaches the casting/pouring of replica material (110) that is made from PDMS/silicone rubber elastomer (Figure 1C, [0171]) creating master mold (112) (Figure 1D, [0171]), where the PDMS degassed (removing of trapped bubbes) [0171], where the master mold (112) is removed from the alginate/hydrogel negative replica mold (108) (figure 1D, [0171]). Aizenberg teaches the process benefit application such as drug delivery [0249].
Aizenberg does not teaches the original mold (102) to be made of resin and is printed using 3D process.
However, Lewis is in the process of forming structure at the size from 1 micron to 15 mm using nozzle [0177], teaches the process of 3D printing inks [0174], inks that comprises [0173].
A person having ordinary skill in the art before the effective date of the claimed invention would combine Aizenberg with Lewis to form 3D printed resin mold with highly fined size parameters to the level of micron size [0177].
Consider Claim 2, the combined Aizenberg (with Lewis) teaches the process curing the alginate/hydrogel negative replica mold using heating/UV [0169]. Aizenberg teaches the casting/pouring of replica material (110) that is made from PDMS/silicone rubber elastomer (Figure 1C, [0171]).
Consider Claims 6-7, the combined Aizenberg (with Lewis) teaches the use of curable polymer (crosslinking) such as Alginates (hydrogels) [0170], and the use of polymer/alginate with stiffness/modules from 1 MPa to 1 GPa [0033] and the previously taught in claim 1. 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). (MPEP 2144.05).
The combined Aizenberg (with Lewis) does not explicitly teach the claimed crosslinking toughness of the hydrogel.
However, the combined Aizenberg (with Lewis) teaches each and every process step and limitation of the applicant’s claims, including the “the process of using and curing of Alginate for negative mold as claimed”. Since the “crosslinked hydrogel negative mold has a toughness of greater than 8 kJ/m3” by the applicant’s claimed process is simply a function of the “the process of using and curing of Alginate for negative mold as claimed”, and the combination of Aizenberg (with Lewis) teaches the claimed process steps. The process of the combination of Aizenberg (with Lewis) would have naturally flow or inherently produced “the crosslinked hydrogel negative mold has a toughness of greater than 8 kJ/m3” unless essential process steps and/or limitations are missing from the applicant’s claims.
Consider Claim 10, the combined Aizenberg (with Lewis) teaches the previously taught in claim 1.
The combined Aizenberg (with Lewis) does not explicitly teach the master mold is a 1:1 replication of the 3D printed resin mold and has a Procrustes score of greater than 0.99 when compared to the 3D printed resin mold.
However, the combined Aizenberg (with Lewis) teaches each and every process step and limitation of the applicant’s claims, including the “the process of using and curing of master mold from of PDMS”. Since the “master mold is a 1:1 replication of the 3D printed resin mold and has a Procrustes score of greater than 0.99 when compared to the 3D printed resin mold” by the applicant’s claimed process is simply a function of the “the process of using and curing of master mold from of PDMS”, and the combination of Aizenberg (with Lewis) teaches the claimed process steps. The process of the combination of Aizenberg (with Lewis) would have naturally flow or inherently produced “master mold is a 1:1 replication of the 3D printed resin mold and has a Procrustes score of greater than 0.99 when compared to the 3D printed resin mold” unless essential process steps and/or limitations are missing from the applicant’s claims.
Consider Claim 11, the combined Aizenberg (with Lewis) teaches process of forming 3D printed resin mold at the size from 1 micron to 15 mm using nozzle (Lewis, [0177]).
Consider Claims 12-13, the combined Aizenberg (with Lewis) teaches the creating of a master mold (112) from PDMS/silicone rubber elastomer (Figure 1C, [0171]) (Aizenberg, Figure 1D, [0171]), for application of cell growth template (Aizenberg, [0226]), therefore, teaches the process of encouraging the growth, not the inhibition of cell growth for containing leachate material or toxins.
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Aizenberg (PG Pub 2011/0192233 A1) in view of Lewis (PG Pub 2016/0346997 A1), and in further view of Lee (US Pat. 6,790,840 B1).
Consider Claims 3-5, the combined Aizenberg (with Lewis) teaches the process benefit application such as drug delivery (Aizenberg, [0249]).
The combined Aizenberg (with Lewis) does not teach the crosslinking toughness of the hydrogel.
However, Lee is in the prior art of cross linking hydrogel for drug delivery (abstract), teaches the resulting of high crosslinking density with less than 16 x 105 mol/cm3 (Col. 5, lines 33-38). 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). (MPEP 2144.05).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Aizenberg (with Lewis) with Lee to provide the hydrogel with properties that overcome the mechanical stiffness for biomedical application (Col. 2, lines 26-30)
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Aizenberg (PG Pub 2011/0192233 A1) in view of Lewis (PG Pub 2016/0346997 A1), and in further view of Thermofisher (Agar, Fisher BP9744-600, lot#193828), with Simmons (Hydrogel-Assisted Double Molding Enables Rapid Replication of Stereolithographic 3D Prints for Engineered Tissue Design, used as evidentiary support)
Consider Claims 8-9, the combined Aizenberg (with Lewis) teaches using of alginate as a hydrogel (Aizenberg, [0170]).
The combined Aizenberg (with Lewis) does not teach the alginate/hydrogel is a double- network alginate hydrogel that comprises 1 % high molecular weight alginate and 2% low molecular weight alginate, nor that the alginate/hydrogel comprises 1.5% w/v agar.
However, Thermofisher is in the prior art of forming Agar having Lot number 193828 and with catalog number BP9744-600 (upper table), teaches the formed agar/alginate having concentration of g/cm2 (lower table).
As the evidentiary support document of Simmons (the application own science publication), teaches the use of this Agar with Lot number 193828 and with catalog number BP9744-600 (page 25320, left Col, last paragraph), resulting in double network hydrogen with 1% HMW and 2% LWM (page 25320, right Col., first paragraph).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Aizenberg (with Lewis) with Thermofisher to use Agar having Lot number 193828 and with catalog number BP9744-600, with reasonable and predictable expectation of success.
Response to Arguments
Applicant’s arguments, filed 07/06/2026, with respect to the rejection(s) of claim(s) 1-13 under 103a have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Aizenberg with Lewis.
Applicant’s arguments with respect to claim(s) 1-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mohammad Mayy whose telephone number is (571)272-9983. The examiner can normally be reached Monday to Friday, 11:00AM-7:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gordon Baldwin can be reached at 571-272-5166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mohammad Mayy/
Art Unit 1718
/GORDON BALDWIN/Supervisory Patent Examiner, Art Unit 1718
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