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 .
Response to Arguments
The Applicant has provided amendments to the claims, and arguments in response to the previous Office Action. The provided drawings have allowed for a withdrawal of the objection to the drawings. Additionally, all of the “such as” language has been removed, and as such, these 35 USC 112(b) rejections are withdrawn. Finally, the dependency of claim 26 has been corrected, and the previous 35 USC 112(b) rejection is withdrawn.
On page 8 of the Applicant’s Arguments, the Applicant states that the ordinary artisan would not have a reasonable expectation of success when applying one cell printing methodology to another cell printing system. The Applicant has provided no explicit reason or evidence for this, and has provided no clear rationale as to why the Examiner’s assertions are improper.
The Applicant continues by stating that the Office has not demonstrated that the combination would predictably result in a perfusable scaffold of claim 1. The Office does not have laboratories to test the viability of the Applicant’s assertions or the predictability of hypothetical combinations. If the Applicant can provide reasonable evidence to suggest that the cited combination would not be predictable, this could be used as evidence of non-obviousness; however, barring evidence, the combination continues to be obvious and predictable. See MPEP 2145(I).
On page 8 of the Applicant’s Arguments, the Applicant asserts that the prior art teaches away from the combination. As neither reference explicitly or implicitly states that these methods would be incompatible, there is no evidence that the prior art teaches away from the combination. See MPEP 2143.01(I).
No claim is allowed. All 35 USC 103 rejections are maintained.
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 1-10, 12, 13, 15-17, 19, 20 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis, et al (PGPub 2018/0030409 [IDS Reference]) and Trujillo-de Santiago, et al (Materials Horizons, 5, 813-822, 2018 [IDS Reference]) and evidenced by Sanchez Rodriguez (Instituto Tecnológico y de Estudios Superiores de Monterrey; Master’s Thesis; May 2019). Lewis teaches a preparation method for a perfusable scaffold for cell culture. See paragraph [0004] [0008]. Lewis provides a fugitive ink composition and an ink composition referred to as a “cell-laden ink.” See paragraph [0168]. Lewis’ “cell-laden ink” is interpreted to be consistent with the claimed “bioink.” Lewis teaches curing of the ink composition, followed by removal of the fugitive ink, wherein a perfusable scaffold is formed. See paragraph [0164] [0168]. Although Lewis does print these inks onto a surface, using a 3D printer, Lewis never explicitly teaches the use of “chaotic printing.” See paragraph [0078].
Trujillo-de Santiago teaches the chaotic printing of bioinks. Trujillo-de Santiago notes that this process provides for the “exponentially fast creation of fine microstructures,” wherein the process provides for improved resolution and speed over current 3D printing techniques. See page 813, “Abstract” section. As such, Trujillo-de Santiago explicitly motivates the ordinary artisan to select chaotic printing over conventional 3D printing techniques, because of the clear advantages. Since Lewis teaches 3D printing techniques, there would be a clear motivation to apply Trujillo-de Santiago’s chaotic printing to the methods of Lewis. Sanchez Rodriguez provides for further motivation by stating the advantages of chaotic printing. See page 63, entire.
With respect to claim 1, Lewis teaches all of the claimed elements, except provides for a method that utilizes conventional 3D printing, instead of the claimed chaotic printing. However, Trujillo-de Santiago explicitly motivates the ordinary artisan to apply chaotic printing, since it is clearly stated that chaotic printing is superior to 3D printing.
With respect to claim 2, Lewis provides for a “cell-laden ink,” which is interpreted as being consistent with the claimed “bioink.”
With respect to claim 3, Lewis generates a perfusable scaffold with a fugitive ink, and 2 bioinks; Trujillo-de Santiago introduces endothelial cells to this scaffold. See paragraph [0168].
With respect to claim 4, throughout Lewis, it is clear that the cells in the bioink fulfill the claimed cell-types. See paragraph [0008].
With respect to claims 5 and 6, both Trujillo-de Santiago and Sanchez Rodriguez indicate that chaotic printing provides for laminar flow and mixing. See Trujillo-de Santiago, page 813, “Conceptual insights” section; page 814, “Using chaos to fabricate fine microstructures” section, 1st paragraph; see Sanchez Rodrigues, page 63, entire. Additinally, Lewis provides methods to suggest that the fugitive ink and the “cell-laden ink” (interpreted as bioink) are premixed prior to printing. See paragraph [0189] [0203] [0205] [0216] [0217].
With respect to claim 7, Trujillo-de Santiago suggests that the claimed mixing would be obvious to the ordinary artisan. See page 814, “Using chaos to fabricate fine microstructures” section; page 815, Figure 2.
With respect to claim 8, Trujillo-de Santiago teaches that striation thickness can be tuned, but explicitly teaches 5-20 µm. See page 818, left column, 1st [full] paragraph.
With respect to claims 9 and 10, although Trujillo-de Santiago does not state the surface area-to-volume ratio or surface density, Trujillo-de Santiago notes the high degree of tunability of the process. See page 813, “Abstract” section; page 820, “Conclusions” section. As such, it would be reasonable to suggest that the ordinary artisan would be wholly capable of tuning the surface area-to-volume ratio, and surface density, in a manner that is ideal for any particular method.
With respect to claim 12, Lewis teaches 3D printing. See paragraph [0004]. Lewis indicates that 3D printing involved extrusion from a nozzle. See paragraph [0155]. Trujillo-de Santiago confirms that 3D printing relies on extrusion, and further indicates that chaotic printing relies on extrusion. See page 814, “Introduction” section; page 816, right column, last paragraph.
With respect to claim 13, Trujillo-de Santiago indicates that the bioink includes gelatin methacryloyl. See page 815, left column, 1st [incomplete] paragraph; page 819, left column, 1st [incomplete] paragraph.
With respect to claims 15-17, Lewis teaches polysaccharides, proteins, and synthetic polymers. See paragraph [0122].
With respect to claim 19, although not explicitly stated in the prior art, the ordinary artisan would be well-versed and highly accustom to the optimization of 3D printing ink consistency. As such, it would be obvious to the ordinary artisan to optimize the flow/viscosity of the bioink.
With respect to claim 20, Trujillo-de Santiago indicates that the bioink can be functionalized with a growth factor. See page 819, left column, 1st [incomplete] paragraph.
With respect to claim 26, Trujilo-de Santiago teaches polymers in the claimed amounts. See page 813.
Conclusion
THIS ACTION IS MADE FINAL. 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 DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651