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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/04/2025 is acknowledged. The traversal is on the ground(s) that the applicant believes that the multiple searches would yield limited results. This is not found persuasive because it cannot be predicted how many results the multiple searches would yield.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/04/2025.
Claims 1-9 are being examined on the merits.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhonhliang Jiang et. al. (From IDS, Comparative cytocompatibility of multiple candidate cell types to photoencapsulation in PEGNB/PEGDA macroscale or microscale hydrogels, Biomed Mater, 2018, October 2nd; 13(6):065012).
Regarding claims 1 and 5, Jiang discloses both polyethylene glycol diacrylate (PEGDA) and polyethylene glycol norbornene (PEGNB) photopolymerized hydrogels having thiol-ene linkages for the PEGNB for encapsulating cells to act as cell carriers (see page 4, 1st para.) and further discloses wherein “The initiator species was synthesized in accordance with previously published procedures [88,94,97]. Briefly, 3.0 g of 2,4,6-trimethylbenzoyl chloride (Sigma Aldrich, USA) was added dropwise to a 250 mL round bottom flask containing an equimolar amount of dimethyl phenylphosphonite and stirred at room temperature under nitrogen overnight” (see page 5, materials and methods).
Regarding claim 3, Jiang discloses wherein the PEGNB microgels were ranging in diameter from 50 um to 160 um (see page 9, results and discussion).
Regarding claim 4, Jiang discloses that after 14 days (336 hours) there were viable cells with encapsulation from PEGNB of about 80% (see figure 6).
Regarding claims 6-7, Jiang discloses that the PEGNB hydrogel is in a final concentration of 10 mM dithiol linker (Mn≈500 Da, Sigma Aldrich, USA) (see hydrogel forming solution, page 6).
Regarding claim 9, Jiang discloses that the composition is for controlled cell
Regarding claim 8, the composition being claimed appears identical to that of Jiang’s disclosure and would inherently have the same activities being claimed. The same structural components would have the same functional activities. Additionally, the claim’s limitations are an intended use of the composition and have no structural or functional difference than that of the prior art and so the prior art would be capable of preforming the claimed activity.
Claims 1-2, 5 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhonhliang Jiang (From IDS, Composite Hydrogels with Controlled Degradation in 3D Printed Scaffolds, IEEE Transacitons on NanoBios., Vol: 18 Issue 2).
Regarding claims 1-2, 5 and 9, Jiang discloses “Poly(ethylene glycol) norbornene (PEGNB), validated for its excellent cytocompatibility, was therefore mixed and infused together with PLA-PEG-PLA into the printed PEGDA scaffold. Cells encapsulated microfluidically into PEGNB microspheres and then polymerized within PEGPLA/NB composite hydrogel maintained excellent viability over a week. Controlled cell release was achieved via the manipulation of PEGPLA/NB composition. By increasing PEGNB proportion in the core, cell release was significantly slowed while increasing PLA-PEG-PLA proportion eventually resulted in a very robust cell release within a short time frame. The functionality of released cells was validated by their cell viability and proliferation potential” (see abstract). Jiang discloses the LAP was used as a photoinitiator with a PEG-dithiol linker (see page 262, II. Results and Discussion). Here Jiang discloses a hydrogel composition with one or more photoreactive monomers and thiol linker (PEGNB with 10 mM PEG-dithiol linker), wherein at least one of the photoreactive monomers comprises methylene functional group (PLA) and one or more cells encapsulated within the hydrogel and discloses that the composition is controlled release.
Jiang discloses less than about 20% of cells are released from the hydrogel (see Figure 2 (c)).
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655