DETAILED ACTION
Claims 1-20 are pending in the instant application.
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 .
Priority
The instant application claims priority to the U.S. Provisional Application Serial No. 63/176,752 filed on 04/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
Claim Objections
Claim 7 is objected to because of the following informalities: ‘sorbitan monolaurate (SML))’ is a typing error, extra parenthesis. Appropriate correction is required. Claim 5 is objected to because of the following informalities: multiple instances of ‘diacrylatee or triacrylatee’. Typo correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 contains the trademark/trade name Triton, Poloxamer. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe emulsifiers and, accordingly, the identification/description is indefinite.
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.
Claims 1-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sears (Emulsion Inks: A New Class of Materials For 3D Printing Porous Tissue Engineered Grafts, A Dissertation by Nicholas Allen Sears, May 2017), Tae et al. (KOR 100810736 B1, 2008), and Zaupa et al. (US 2019/0194460 A1).
Sears discloses that recent advances in 3D printing technologies have enabled the fabrication of custom-fit scaffolds that resemble native tissue. Although these scaffolds can more closely mimic defect shape, new inks are needed to provide tunable control over multiple levels of scaffold structure and function. To address these limitations, we have developed an extensible system for printing complex tissue engineered scaffolds by creating emulsion templated inks. These emulsion inks exhibit tunable pore sizes, modulus, and strength. Formulation of inks with viscous, reactive macromers results in extruded material that holds its shape after extrusion and polymerizes rapidly upon exposure to UV light (ii). Photocurable emulsion inks for use with solid freeform fabrication (SFF) to generate constructs with hierarchical porosity are presented. A high internal phase emulsion (HIPE) templating technique was utilized to prepare water-in-oil emulsions from a hydrophobic photopolymer, surfactant, and water (pg 27). In this method a hydrophobic organic phase is dispersed within a hydrophilic aqueous phase, forming a viscous emulsion referred to as a hydrocolloid. Once extruded, the continuous phase, consisting of the hydrogel solution, is polymerized using UV irradiation to lock in the emulsion geometry (pg 67).
Sears discloses a polymer solution continuous phase comprising a photoinitiator but does not explicitly mention emulsifier-coated hydrogel microparticles dispersed within a polymer solution).
Tae discloses a polysaccharide-functionalized nanoparticle comprising a core made of a biodegradable polymer, an external hydrogel film made of biocompatible polymer emulsifier (Abstract). Polysaccharide-functionalized nanoparticles, hydrogel carrier, nanoparticle-protein-hydrogel complex, can have sustained release of bone filler protein drug. Tae discloses dispersion of nanoparticles filled with the protein in an aqueous biocompatible polymer solution for preparing a hydrogel carrier (pg 8, 4th paragraph).
Above references do not explicitly mention polymer solutions comprising hexanediol diacrylate.
Zaupa discloses a composition comprising a gelatin polymer solution, photoinitiator useful for 3D printing, extrusion systems (Abstract). The composition is useful for new bio-fabrication technologies for use in biomedical and alimentary fields ([0001]). The polymer solution comprises hexanediol diacrylate (HDDA) ([0013]). Zaupa discloses the use of these compositions for bioink printing ([0235]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to create a bioink composition comprising emulsifier-coated hydrogel microparticles dispersed within a polymer solution comprising a photoinitiator to create a 3D bioink scaffold for tissue regeneration. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 2, Sears discloses bioactive hydrogel solutions (pages 1 and 69).
Regarding claims 3-4, Sears discloses various hydrogel inks – gelatin methacrylate (GelMA), poly(ethylene glycol) diacrylate (PEGDA) (pg 68).
Regarding claims 5-6, Zaupa discloses HDDA.
Regarding claims 7-8, Sears discloses the use of PGPR for creating emulsion inks (pg 31).
Regarding claims 9-10, Sears discloses BAPO as photoinitiator (pg 31).
Regarding claim 11, Sears discloses mixing DUDMA, PPG-DMA, BAPO photoinitiator and PGPR surfactant (pg 31). Zaupa discloses that HDDA is routinely used 3D printing polymer solutions as discussed above. Tae discloses that hydrogel microparticles can be coated with emulsifiers. In combination, one of ordinary skill in the art would create an emulsifier-coated hydrogel microparticles dispersed within a polymer continuous phase for 3D printing with bioink emulsions. PGPR, GelMA, and HDDA are routinely used in bioink printing.
Regarding claim 12, BAPO is taught above.
Regarding claim 13, Tae discloses that sustained-release systems routinely encapsulate and deliver growth factors in tissue regeneration (pg 3, 2nd paragraph). Sears teaches cell encapsulation in crosslinked hydrogels (pg 21, last paragraph).
Regarding claims 14-15, growth factors are taught above.
Regarding claim 16, Sears discloses that emulsion inks are rapidly cured after deposition by constant UV irradiation to form high porosity constructs (pg 29, last paragraph).
Regarding claim 18, Sears discloses that emulsion inks are useful for creating a biomaterial scaffold for bone regeneration (pg 43).
Regarding claims 19-20, UV light to form a solid scaffold is taught above.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sears (Emulsion Inks: A New Class of Materials For 3D Printing Porous Tissue Engineered Grafts, A Dissertation by Nicholas Allen Sears, May 2017), Tae et al. (KOR 100810736 B1, 2008), and Zaupa et al. (US 2019/0194460 A1) as applied to claims 1-16 and 18-20 above, and further in view of Yang et al. (US 2020/0179574 A1).
Yang discloses methods, compositions, devices, and systems for the 3D printing of biomedical implants (Abstract). Yang discloses micro-continuous liquid interface production using biomaterial ink ([0072]).
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have contemplated the microscale continuous liquid interface production for creating bioscaffolds. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights