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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 March 2026 has been entered.
Election/Restrictions
Applicant has cancelled the claims directed to the non-elected invention.
Claim Status
Claims 1, 6, and 16 are currently amended, claims 14-15 were previously cancelled, claim 2 is newly canceled, and claims 1, 3-13 and 16 have been considered on their merits.
Withdrawn Rejections and Objections
The claim rejections under 35 U.S.C. § 103 have been withdrawn due to the instant amendments. However, upon further consideration, a new rejection is set forth below.
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 1, 3-9, 11-13, and 16 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 Plachy et al. (EP3482934, published 05/15/2019, IDS ref., of record).
The machine translated version from the IDS for EP3482934 was utilized as the reference.
This is a new rejection, necessitated by applicants amendments to the claims. A response to Applicant’s traversal follows the rejection below.
Regarding claim 1, the phrase “for carrying out medical and/or pharmacological examinations” is an intended use statement and is not limiting because it does not add structure or function to the method for producing cell cultures. Even if the phrase was limiting, Lavik teaches the models produced by the disclosed method allow the study of components of disease progression and can be used for screening therapies (para. [0002]), which read as medical examinations.
Lavik teaches a screen-printing process wherein a prepared screen (printing screen) is positioned over a surface (e.g., the substrate), solutions comprising gel precursors, cells, and/or other layer components (printing medium containing living cells) are added to the screen, and a blade is used to move the solutions over the screen (para. [0034]). Lavik teaches the screen having a specific pattern is placed over the substrate, a solution comprising the components to be printed in the specific layers are combined, mixed together and placed over the substrate, and then a blade is pushed across the screen to ensure the solution is evenly spread over the screen (para. [0041]). Lavik discloses the screen-printing method with tissue models as the product (para. [0002]), however, the initial steps read as producing cell cultures which develop into tissues. Lavik teaches once the printed materials completely set, the constructs are immersed in the appropriate media and cultured with media changes (para. [0073]). Therefore, Lavik teaches a method for producing cell cultures in which a printing medium containing living cells in which the printing medium is printed through a printing screen (claim 1).
Lavik is silent to wherein a carrier structure is printed alternately with the printing medium containing living cells.
However, Plachy teaches a printing system for printing three-dimensionally shaped structures, such as carrier substrates, with a printing device which is a three-dimensional screen-printing system (para. [0001]). Plachy teaches a printing compound in flowable form is applied to a printing screen and is pressed through the screen onto a substrate by means of a blade (para. [0002]). Plachy teaches the printing device is able to select different printing screens and use them as a basis for the printing process, which enables different and highly complex three-dimensional structures to be printed in a similar manner with the same printing device using differently designed printing screens (para. [0005]). Plachy teaches the printing process is completed in layers to create the three-dimensional structures, wherein two or more printing processes can also be carried out directly one after the other with the same printing screen (para. [0005]).
Therefore, it would have been obvious to one of ordinary skill in the art to print the carrier structure alternately with the printing medium containing living cells with a reasonable expectation of success because Plachy teaches screen printing complex three-dimensional structures, such as carrier substrates, can be completed directly one after the other with the same or different printing screens. One would be motivated to print the carrier structure alternately with the printing medium containing living cells because Plachy teaches three-dimensional printing processes can be used to produce complex three-dimensional structures in a short time at low cost (para. [0002]). While Plachy does not specifically teach the printed carrier structures are for the intended use for supporting cell cultures, the concept remains the same and printing a three-dimensional carrier structure to produce complex structures was known in the art before the effective filing date of the instant invention. Thus, it would be reasonable to conceive printing a structure designed to support a plurality of cell cultures separately from each other.
Regarding claim 6, Lavik teaches screen-printing the crypt structure of the colon model using printing screens with holes in the appropriate dimensions (para. [0080]) as illustrated by figure 9 (Method: Colon Printing), which discloses screens with a plurality of holes (cutouts) formed separately from one another. The individual crypt structures of the colon model read as a plurality of cell agglomerations being separated from one another on the carrier structure, which read on the limitations of claim 6. Additionally, the carrier structure taught by Lavik would be considered an object carrier, as the underlying cells carry the cell agglomerations of the colon model. The remaining limitations are interpreted as optional due to the use of “or”.
Regarding claims 3 and 4, Lavik teaches the screen having a specific pattern is placed over the substrate, a solution comprising the components to be printed in the specific layers are combined, mixed together and placed over the substrate (carrier structure), and then a blade is pushed across the screen (blading operation) to ensure the solution is evenly spread over the screen (screen printing process) (para. [0041]). The remaining limitations are interpreted as optional due to the use of “or”.
Regarding claim 5, Lavik teaches screen-printing a retinal tissue model and colon model, which are multilayer models (figures 8 and 9). Both of these multilayer models read as three-dimensional cell cultures. Therefore, Lavik teaches the method wherein by printing the printing medium onto a carrier structure three-dimensional cell cultures are generated. The remaining limitations are interpreted as optional due to the use of “or”.
Regarding claims 7 and 9, Lavik teaches screen-printing the crypt structure of the colon model using printing screens with holes in the appropriate dimensions (para. [0080]) as illustrated by figure 9 (Method: Colon Printing), which discloses screens with a plurality of holes (cutouts) formed separately from one another (claim 7). The screen-printing process where the printing medium is delivered through individual holes in the screen reads as the printing medium is printed at individual positions which would be independent of each other on a carrier structure (claim 9). The remaining limitations are interpreted as optional due to the use of “or”.
Regarding claim 8, Lavik teaches screens with pores (cutouts) from about 20-500 µm (para. [0034]). Lavik is silent to wherein at least one cutout of the printing screen for the passage of the printing medium has a diameter from 1 mm to 100 mm.
However, the size of the cutout would have been readily optimizable by one of ordinary skill in the art by routine experimentation in order to achieve the desired results, absent evidence to the contrary. Considering the size difference between Lavik and the instant cutout is merely 0.5 mm, this slight difference could be optimized based on the viscosity of the printing medium or the desired quantity of cells required to pass through the cutout in the screen during the printing process. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See M.P.E.P. § 2144.05 (I).
Regarding claims 11 and 12, Lavik teaches the major requirement for screen printing is that the gel is able to set up, crosslink, or phase separate within seconds to a minute (para. [0060]). The step of drying or tempering is interpreted the same as the “set up” process taught by Lavik. The set up of the hydrogel taught by Lavik is the process of the sol-gel transition to inherently involve drying and tempering. The process of sol-gel transition is considered as tempering as the solution becomes viscous, and at the same time the solution of Lavik becomes gel and at the same time, the solution is spontaneously evaporated, i.e. dried (air-dried). It is an inherently property of a liquid or gel sitting for any length of time, the liquid will evaporate and thus have a drying effect. Therefore, the teachings of Lavik disclose the viscosity of the printing medium can be changed by a drying or tempering step (claim 11); and this disclosure reads on a sol-gel transition is generated after the printing of the printing medium by a drying or tempering step (claim 12). The remaining limitations are interpreted as optional due to the use of “or”.
Regarding claim 13, Lavik teaches screen-printing the crypt structure of the colon model using printing screens with holes in the appropriate dimensions (para. [0080]) as illustrated by figure 9 (Method: Colon Printing), which discloses screens with a plurality of holes (cutouts) formed separately from one another. The screen-printing process where the printing medium containing living cells is delivered through individual holes in the screen reads as the printing medium is printed at individual positions on a carrier structure, the individual crypt structures of the colon model read as a plurality of cell agglomerations being separated from each other on the carrier structure, which read on the limitations of claim 13. Additionally, figure 9 depicts a complex three-dimensional structure requiring at least four different cell types which build upon each other, wherein the layers of cells support the next layer of cells. This example of layering demonstrates a carrier structure for the cells. Lavik teaches the crypt structures are printed by printing gels with holes and then printing the epithelial and goblet cell layers (para. [0080]).
Regarding claim 16, Lavik teaches screen-printing the crypt structure of the colon model using printing screens with holes in the appropriate dimensions (para. [0080]) as illustrated by figure 9 (Results), which discloses the specific predefined arrangement onto the carrier structure of the printing medium.
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 Traversal
Applicant's arguments filed 02 March 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments directed to the rejections under 35 USC § 103 regarding the Plachy reference, Applicant asserts the Examiner has incorrectly characterized the teachings of the reference as suggesting the printing of carrier substrates. Applicant cites paragraph [0001] of Plachy and asserts the reference teaches printing onto the complex three-dimensional surfaces. This is not persuasive because it is understood that Plachy is simply providing examples of what three-dimensional objects can be printed while utilizing their invention. Plachy is teaching a printing system in which three-dimensional objects can be produced on a substrate. The disclosure of Plachy following “in particular” are examples of printed objects, which include carrier substrates.
It is understood that the reference has been originally published in German and has been translated to English and may not be presented with ideal punctuation and grammar, however, it is believed that the reference is providing examples of complex three-dimensional objects which can be printed not surfaces to which are to be printed onto, as Applicant is suggesting.
Applicant also asserts that Lavik, at Figure 9, depicts anatomical features of a single integrated colon tissue model and are not describing predefined receiving sections on a carrier structure designed to receive and maintain separation of distinct cell cultures or cell agglomerations. This is not persuasive because, in this illustrative example provided by Lavik, while the image and description describe a tissue model which is integrated model, the printing process reads on the limitations of the claim. The cells are being placed by way of the screen-printing process through individual cutouts which place the cells in a separated fashion. The crypt structures which are made of the underlying cells described by Lavik read as a three-dimensional object with predefined receiving sections. These underlying cells form a specialized structure which reads on a carrier structure because the underlying cells form a structure to support the subsequent layers of different cell types.
In the process of printing the individual cell agglomerations depicted by Lavik it would naturally flow that eventually these individual agglomerations would develop into a three-dimensional tissue model. However, the printing medium comprising the cells are being placed onto the carrier via individual cutouts of the printing screen, thus, read on the limitations set forth in the claims.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., maintaining separation of distinct cell culture) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 10 is 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 Plachy et al. (EP3482934, published 05/15/2019, IDS ref., of record) as applied to claims 1, 3-9, 11-13, and 16 above, and further in view of Coté (Current Protocols in Cell Biology (1998), of record).
This is a new rejection, necessitated by applicants amendments to the claims. A response to Applicant’s traversal follows the rejection below.
Regarding claim 10, Lavik in view of Plachy are silent to wherein during printing superimposition of a sterile gas medium on the printing medium is conducted.
However, Coté teaches all aseptic work should be conducted in a laminar cabinet (Basic protocol 2, Use of the horizontal laminar-flow clean bench). A laminar cabinet implicitly provides sterile air (a gas) superimposed on the printing medium.
Therefore, it would be obvious to one of ordinary skill in the art to conduct the method of Lavik in view of Plachy using the technique taught by Coté because when working with cells one would want to avoid contamination. There would have been a reasonable expectation of success in conduct the method of Lavik in view of Plachy using the technique taught by Coté because sterile techniques are well known in the art pertaining to cell culture and it would be implied that Lavik would have used sterile techniques, to include the use of sterile air, when working with cell cultures.
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 Traversal
Applicant has not provided any traversal regarding this rejection.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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