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All outstanding objections and rejections made in the previous Office Action, and not repeated below, are hereby withdrawn.
The new grounds of rejection set forth below are necessitated by applicant’s amendment filed on 6/10/26. In particular, claim 1 has been amended to further limit the polymer to methacrylate introduced hyaluronic acid, the crosslinking agent and the type of bioprinting.
The newly introduced limitations and/or the new claims were not present at the time of the preceding action. For this reason, the present action is properly made final.
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 § 102
Claim(s) 1, 3, 5 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017/205663 (herein Health).
As to claims 1, 3, Health discloses a method of preparing a bio-ink for bioprinting (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.
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 7, a light source is utilized (paragraph 64, 71, 108-110 and examples, thus reading on irradiated), which turns into a solid (adjust physical properties, see paragraph 32 and examples).
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.
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.
Claim(s) 1, 3, 5 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2017/205663 (herein Health).
The discussion with respect to Health set-forth above is incorporated herein by reference.
As to claims 1, 3, 5 and 7-9, 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.
As to claim 10, the irradiation time is not disclosed. However, one faced with the examples and disclosure of Health would recognize that the time of irradiation is short enough to cure/crosslink the composition. Further, it is implicit in Health that the irradiation in the examples is short (e.g. less than 60 seconds) because it is performed in-situ in the living tissue. Further, one would recognize that the time for crosslinking/printing is a result effective variable because too short time of irradiation would lead to little to incomplete curing/crosslinking, while too long is wasteful in terms of time, energy, cost and safety of the person during surgery. Therefore, it would have been obvious at the time of the invention to irradiate for the appropriate amount of time because one would want to irradiate long enough to cure/crosslink the 3D printed material to solidify but not too long for safety and economic reasons.
Conclusion
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.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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, 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
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