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 Status
Claims 2-14 are currently amended, claim 1 was newly cancelled, claim 15 was previously cancelled, claim 19 is new, and claims 2-14 and 16-19 have been considered on their merits.
Withdrawn Rejections
Applicant’s arguments, see Applicant’s remarks, filed 29 January 2026, with respect to the rejections of claims 1-14 and 16-18 under 35 USC § 102(a)(1) and 35 USC § 103 have been fully considered and are persuasive. Specifically, the arguments/amendments directed to Lavik not teaching the change in temperature related to the drying and tempering steps. Therefore, the rejections has been withdrawn.
However, upon further consideration, a new ground of rejection is made in view of Lavik (of record) in view of D’Lima.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lavik et al. (US 2019/0187128 published 06/20/2019; of record) in view of D’Lima et al. (US 2015/0351896 A1, published 10 December 2015).
This is a new rejection, necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal follows the new rejection below.
Regarding claims 19 and 13-14, Lavik et al. teach a process of screen printing multilamellar structures that promote specific cellular organization and the tissue model obtained using said process; and said tissue model can be used for implantable therapies (para. [0002] and [0006]). This reads as a method for producing a biological tissue utilizing a printing screen. Lavik et al. teach a prepared screen is positioned over a surface (a support), solutions comprising gel precursors, cells, and/or other layer components (reads as printing medium containing living cells) are added to the screen, and a blade is used to move the solutions over the screen to the unexposed areas of the surface (para. [0034]). Regarding the successive printing steps, Lavik et al. teach a method of making a multilamellar tissue model comprising; positioning a first screen having an exposed first pattern over a substrate, placing a first solution to be printed onto the first screen, pushing the blade across the first screen to spread the first solution into the exposed first pattern, removing the first screen to reveal a first layer, positioning the second screen and further repeating the process wherein the layers are layered in succession (para. [0048]).
Lavik et al. does not teach the drying and tempering of the printing medium between successive steps wherein the temperature comprising increasing or decreasing a temperature of the printing medium. However, utilizing a thermos-responsive printing medium was known in the art and thus, obvious to use.
D’Lima teaches methods of printing a bio-ink (reads as a printing medium) on a substrate (reads as a support) and methods of printing a live tissue (Abstract). D’Lima teaches print nozzles distributed with one or more masks (para. [0021] and Fig. 4). The mask of D’Lima reads as a printing stencil. D’Lima teaches a method of producing live tissue comprising: i) positioning a printhead comprising a two-dimensional array of print nozzles with proximity of a tissue culture substrate; and ii) ejecting a bio-ink comprising cells through a two-dimensional array of print nozzles onto the tissue culture substrate (para. [0031]). D’Lima teaches in some embodiments, the printhead is in contact with the substrate and a two-dimensional shape is printed by simultaneously firing the print nozzles that are required to create any shape or a complex three-dimensional shape is constructed from layers of two-dimensional shapes (para. [0038]). D’Lima teaches in some embodiments, the methods of bioprinting further comprise polymerizing the bio-ink by applying a specified temperature (reads as increasing or decreasing a temperature) to the bio-ink wherein the bio-ink is polymerized before or after it is printed on the substrate (para. [0038]). D’Lima teaches in some embodiments, the live tissue is produced by printing a plurality of bio-ink layers (para. [0038]). The temperature sensitive polymerization of the bio-ink reads as a drying or tempering step, as the polymerization would create a viscosity change. D’Lima teaches the heating element raises the local print nozzle temperature to between 100-400 degrees wherein, the temperature of the bio-ink is raised for less than about 1 to 10 micro seconds (para. [0039]). Regarding the process of sol-gel transition (claim 13), this process is considered as tempering as the solution begins to solidify, and at the same time the solution of D’Lima becomes gel and at the same time is dried, thus, the liquid will evaporate and have a drying effect.
Therefore, it would have been obvious to utilize the temperature sensitive printing medium of D’Lima in the method of screen printing tissues of Lavik with a reasonable expectation of success because both references teach methods of printing biological tissue comprising living cells. One would be motivated to utilize the temperature sensitive printing medium of D’Lima in the method of screen printing tissues of Lavik because D’Lima teaches a method of bioprinting comprising polymerizing the bio-ink by applying a specified temperature (reads as increasing or decreasing a temperature) to the bio-ink wherein the bio-ink is polymerized before or after it is printed on the substrate (para. [0038]). As both references teach methods for bioprinting with living cells, it would have been obvious to utilize the temperature sensitive printing medium in the method of Lavik to arrive at a tissue as a result of the printing (claim 14).
Regarding claim 2, this claim is interpreted as a method according to claim 19, wherein: the printing medium is printed through the printing screen onto the support. The remaining limitations are interpreted as optional due to the use of “or”. Lavik et al. teach the limitations of the claim as indicated in the rejection of claim 19.
Regarding claims 3-5, directed to a method where the printing medium is printed in layers (claim 3) and where the printing medium is conveyed through the printing screen and onto the support by one printing blade movement (claims 4 and 5), Lavik et al. teach a method of making a multilamellar tissue model comprising; positioning a first screen having an exposed first pattern over a substrate (the support), placing a first solution to be printed onto the first screen, pushing the blade across the first screen to spread the first solution into the exposed first pattern (a blading movement), removing the first screen to reveal a first layer, positioning the second screen and further repeating the process wherein the layers are layered in succession (printed in layers) (para. [0048]).
Regarding claims 6 and 7, directed to printing the printing medium onto the support a three-dimensional cell culture (claim 6) where the printed cells develop into organ tissue as a result of the printing (claim 7). Lavik et al. teach screen printed multilayered cell culture which inherently makes the cell culture three-dimensional. Lavik et al. teach a screen-printed colon (a three-dimensional cell culture and organ tissue) comprising a neural layer, stromal layer with dendritic cells, and the epithelial/goblet cell layer with the crypt structures that are critical to normal cell function (Example 3 para. [0080] and Fig. 9).
Regarding claim 8, directed to a printing screen has at least one cutout for the passage of the printing medium. Lavik et al. teach a printing screen with a barbell shaped cutout (Fig. 7 and para [0078]). Lavik et al. teach screens with multiple cutouts in the process for printing a Bruch's membrane and two of the cellular layers of a retinal tissue model (Fig. 8 and para. [0027]).
Regarding claim 9, directed to different printing screens are used for printing a tissue in order to produce differently shaped printing layers. Lavik et al. teach different screens are used for screen printing the different layers, specifically step 3, printing the goblet cells to form the crypts has multiple circular openings exemplifying the difference in the screens used for different layers (Fig. 9 (1-4)).
Regarding claim 10, directed to different printing media with different cells are used for printing different layers for producing tissue with different layer properties. Lavik et al. teach printing of the epithelial and goblet cell layers (different cells with different properties), as epithelial and goblet cells have different structure and function (Example 3 para. [0080] and Fig. 9).
Regarding claim 11, directed to tissue variation is generated with in a printing layer in an x/y direction. Lavik et al. teach a printing a colon with a crypt structure (Example 3 para. [0080] and Fig. 9). A crypt structure is a three-dimensional structure, which inherently has both x and y directionality.
Regarding claim 12, directed to the printing medium being sol-gel matrix. Lavik et al. teach a synthetic multilamellar tissue model said model comprising (i) a substrate, (ii) a foundation comprising at least one layer comprising a hydrogel (reads as sol-gel matrix), and (iii) at least one non-foundational layer comprising one or more of proteins, cells, a hydrogel, a second constituent, collagen, and any combination thereof (para. [0007]).
Regarding claim 16, D’Lima teaches the manufactured tissue can be skin tissue (para. [0041]). Therefore, Lavik in view of D’Lima teach the limitations of the claim.
Regarding claim 17, directed to the partial organ is for transplantation. Lavik et al. teach the tissue model can be used for implantable therapies (para. [0002]). The tissue model according to Lavik et al. reads as the partial organ is for transplantation. Optional disclosures are not limiting therefore, the disclosure after “optionally” are not considered.
Regarding claim 18, D’Lima teaches bioprinting vascular cells results in formation of a blood vessel or a portion thereof (para. [0038]). Blood vessels serve as a tissue structure thus, the bioprinted blood vessels of D’Lima read as tissue scaffolds. Therefore, it would have been obvious to one skilled in the art to use the method of Lavik in view of D’Lima for the purpose of producing tissue scaffolds (blood vessels) because printing biological tissue, to include vascular tissue, is known in the art. One of skill in the art would have been motivated at the time of invention to use the method in order to obtain the vascular tissue as suggested by the references with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments with respect to Lavik does not disclose or suggest drying and tempering between successive printing steps by increasing or decreasing a temperature of the printing medium as compared to a temperature of the printing medium during the printing step have been considered but are moot because the new ground of rejection does not rely on Lavik to address these limitations.
Applicant’s arguments with respect to claims 16 and 18, specifically the Arslan-Yildiz reference, have been considered but are moot because the new ground of rejection does not rely on Arslan-Yildiz applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Relevant prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gungor-Ozkerim et al. (Biomater Sci. 2018 May 01; 6(5): 915-946).
Gungor-Ozkerim teaches an overview of bioprinting processes, and discusses solutions of a biomaterial or a mixture of several biomaterials in the hydrogel form, usually encapsulating the desired cell types, termed the bioink, is used for creating tissue constructs. Gungor-Ozkerim teaches biofabrication is an emerging research area and includes the creation of tissue constructs with a hierarchical architecture. Gungor-Ozkerim teaches due to its thermoresponsive property, gelatin can be tuned and physically cross-linked during bioprinting by thermal gelation, which helps to maintain the shapes of the bioprinted structures.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS A. HUMPHRIES whose telephone number is (703)756-5556. The examiner can normally be reached Monday - Friday, 7:30am - 4:30 pm.
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, James Schultz can be reached at 571-272-0763. 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.
/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
Prosecution Insights