DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action.
All outstanding objections and rejections made in the previous Office Action, and not repeated below, are hereby withdrawn.
Note that the rejections have been amended in response to the amendment.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/21/26 has been entered.
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 Rejections - 35 USC § 103
Claim(s) 1, 3, 5 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2017/205663 (herein Health) in view of Bioprinting Protocol GelMA Bioink (herein Bioprinting Protocol PDF, originally published 21 Apr 2019 and archived by the Internet Archive/Wayback Machine on 28 Nov 2020).
https://web.archive.org/web/20201128194130/https://www.cellink.com/wp-content/uploads/2019/04/Bioprinting-protocol-GelMA-A-10-Apr-2019.pdf
The discussion with respect to Health set-forth above is incorporated herein by reference.
As to claims 1, 3, Health discloses a method of preparing a bio-ink for bioprinting a biological structure (see abstract, paragraph 12-13 and examples) comprising mixing methacrylated hyaluronic acid (methacrylate introduced hyaluronic acid, MeHA, see paragraph 61 and example 4), a crosslinking agent such as tetraethylene glycol diacrylate (TEGDA, paragraph 31) and a photoinitiator (paragraph 32,109, and examples that use Irgacure).
Specifically, note that tetraethylene glycol diacrylate is a polyethylene glycol diacrylate (thus reading on claim 3) with 4 ethylene glycol units, two acrylate functional units and a molecular weight of 302.32 g/mol. Since it has two (diacrylate) acrylate groups, the equivalent weight of the crosslinking agent is about 151 (302.32/2).
As an initial matter, the limitation bioprinting is performed… is an intended use limitation, which is given weight insofar as if it materially affects the composition. Nevertheless, the compositions of Health are capable of bioprinting by 3d printing methods such as fused deposition modeling with a light source. Specifically teaching the same/similar method. See paragraph 64, 72 and examples.
While Health does not teach an example with crosslinker such as tetraethylene glycol diacrylate, both tetraethylene glycol diacrylate and higher molecular weight polyethylene diacrylates are taught. See paragraph 31. Therefore, it would have been obvious to utilize tetraethylene glycol diacrylate or similar weight polyethylene glycol diacrylates because they are taught as suitable in Health.
Health teaches that a light source is utilized (paragraph 64, 71, 108-110 and examples, thus reading on irradiated) to irradiate the bioink, which turns into a solid (adjust physical properties, see paragraph 32 and examples).
Further, it is implicit in Health that the irradiation is performed in-situ in the living tissue.
Health is silent on the length of time to crosslink the bioink in situ.
The Bioprinting Protocol PDF teaches similar methods of printing acrylate (GelMA) bioinks. See page 1. The method involves photocuring (irradiating) at various wavelengths (365 or 405 nm). See table at bottom of page 4, wherein custruct depth for the bioink are shown at either 1 mm or 3 mm, which should be irradiated between 10 and 30 seconds. Again, see table at bottom of page 4. The Bioprinting Protocol PDF makes it explicit that over exposure “might damage the cells” and not to expose for more than 120 seconds. Therefore, it is clear from the Bioprinting Protocol PDF that one would want to irradiate between 10 and 30 seconds in order to crosslink the bioink, however keeping it minimal as to not damage living cells. See page 4.
Therefore, it would have been obvious at the time of the invention to have modified the method of Health with an irradiation time of 10 to 30 seconds as suggested by the Bioprinting Protocol PDF because one would want to irradiate long enough to crosslink the bioink but minimize the exposure as to not damage cells. See page 4 of the Bioprinting Protocol PDF.
As to claim 5, the photoinitiator is lithium phenyl-2,4,6-trimethylbenzoylphosphinate (LAP). See paragraph 32. Also note the other photoinitiators listed that read on the claimed invention. Also note paragraph 32 and examples that utilize Irgacure® 2959, 2-hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone reading on a claimed species.
As to claim 8, the photoinitiator (paragraph 32) causes crosslinking (paragraph 61) when exposed to light (paragraph 108-109). Also see examples.
As to claim 9, the wavelength of the light is 400 to 700 nm (paragraph 65 and 110) or 280 to 315 nm (paragraph 108 and 110). Also see examples which utilize 280 nm.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
The declaration is acknowledged, which contains both opinion that 1 to 60 seconds is not implicit and data showing that shorter irradiation time is advantageous in reducing cell damage.
In response, the amendments are not in view of the Bioprinting Protocol PDF as elucidated above in the prior art rejections. In summary, the Bioprinting Protocol PDF motivates one to an irradiation time of about 1 to 30 seconds in order to crosslink the bioink and reduce cell damage. Therefore, the amended claims are obvious over Health and the Bioprinting Protocol PDF as elucidated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK S KAUCHER whose telephone number is (571)270-7340. The examiner can normally be reached M-F 8-6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie Lanee Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK S KAUCHER/Primary Examiner, Art Unit 1764
