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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-7 in the reply filed on September 16, 2025 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salice et al. (WO 2017/005730 A1, hereinafter Salice).
Regarding Claims 1, 4, and 6, Salice teaches a method of 3D fused deposition modeling conducted in the presence of a sacrificial composition comprising a casein protein not disclosed to exhibit enzymatic activity (per Page 11 Lines 12-18 that identifies both casein and starch as fillers to be used in the composition), a glycerol plasticizer, and water (per Page 12 Lines 2-27 specifying that water and glycerol are used with the starch, and that the composition can use more than one filler).
Regarding Claims 2-3, Salice teaches that some of the filler content may be inorganic in Page 11 Lines 12-18.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaunier et al. (“Plasticized protein for 3D printing by fused deposition modeling” available in the file wrapper as the 7-page NPL submission dated July 29, 2022).
Regarding Claims 1 and 6, per the Abstract and throughout the disclosure Chaunier teaches fused deposition modeling with a filament composition comprising a zein protein not disclosed to exhibit enzymatic activity, glycerol expressly described as a plasticizer (“zein can be thermoplasticized after blending with with polar plasticizers as glycerol” per the last paragraph of the Introduction as seen on Page 4), and water (present initially in the zein as moisture content “MC=5%” per the last paragraph of Page 5). Note that since the filament composition is disclosed as being usable for controlled drug release, it is considered a sacrificial composition.
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.
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chaunier in view of Shoseyov et al. (WO 2017/006330 , hereinafter Showseyov).
Regarding Claim 5, Chaunier teaches the method as applied above, but is silent on whether the composition comprises an enzyme.
In analogous art pertaining to 3D printing, Shoseyov teaches in Page 14 Lines 24-29 that cross-linking proteins may be accomplished with enzymes, and therefore it would have been obvious to include an enzyme in Chaunier to cross-link Chaunier’s protein.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Salice as applied to Claim 6 above.
Regarding Claim 6, Salice teaches in Page 11 Lines 19-21 that the composition can include up to 50% by weight of casein and starch filler in total, allowing for an embodiment with 30% casein and 20% starch filler. Salice further teaches in Page 12 Lines 6-18 water and glycerol amounts of up to 40% by weight compared to starch in order to destructure the starch, implying 8% by weight amounts of both water and glycerol in the composition. While the reference water content is slightly less than the 10% lower limit of water weight% in the Claim, such a difference is small enough that it would have been obvious to use 10% by weight of water to achieve proper destructuring with routine optimization.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN M OCHYLSKI whose telephone number is (571)270-7009. The examiner can normally be reached Monday-Friday 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen Hauth can be reached at (571) 270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN M OCHYLSKI/Primary Examiner, Art Unit 1743
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