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 .
Election/Restrictions
Applicant's election with traverse of claims 1-18 in the reply filed on July 10th, 2026, is acknowledged. The traversal is on the grounds that there would not be a serious search and/or examination burden. This is not found persuasive because the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). In other words, this separate classification shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. Furthermore, product and method claims use different search strategies as process limitations are treated differently. The prior art applicable to one invention would not likely be applicable to another and the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Claims 44 and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 10th, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1, 5, 6, 10, 11, 13 and 17 are objected to because of the following informalities:
Claim 1, line 5, “in solution” should say “in the biopolymer solution” for claim language consistency.
Claim 1, line 8, “tunable properties” should say “the tunable properties” for claim language consistency.
Claim 5, line 2, “pre-alignment” should say “the pre-alignment” for claim language consistency.
Claim 5, line 2, “the biopolymers” should say “the biopolymer” for claim language consistency.
Claim 6, line 2, “in solution” should say “in the biopolymer solution” for claim language consistency.
Claim 10, line 2, “the solution” should say “the biopolymer solution” for claim language consistency.
Claim 11, line 1, “geometry or mechanics” should say “the geometry or mechanics” for claim language consistency.
Claim 13, line 2, “the material” should say “the biopolymeric material” for claim language consistency.
Claim 17, lines 1-2, “tunable properties” should say “the tunable properties” for claim language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “the additive manufacturing process” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
The dependent claims necessarily inherit the indefiniteness of the claims on which they depend.
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 1-3 and 5-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et al. (US 20190275199 A1; hereafter Rogers).
Regarding claim 1, Rogers discloses an additive manufacturing method to produce a biopolymeric material ([0006]) with tunable properties ([0076, 0095]), the method comprising:
a. dissolving a biopolymer ([0060-0061]; biopolymer) in a solvent ([0061]; ionic liquid mixture) to make a biopolymer solution comprising biopolymer molecules ([0061, 0091]; the biopolymer is dissolved in the ionic liquid mixture to form a 3D printing composition comprising the molecules of the biopolymer);
b. pre-aligning the biopolymer molecules in the biopolymer solution ([0095, 0120]; the controlled concentration and/or deposition nozzle pressure would result in a pre-alignment of the biomolecules, see instant claims 5 and 6);
c. depositing the biopolymer solution ([0107]; extruding the 3D printing composition through a deposition nozzle); and
d. solidifying the biopolymer ([0122]), thereby forming the biopolymeric material with the tunable properties;
wherein one or more conditions from pre-alignment, deposition, or solidification are used to tune properties of the biopolymeric material ([0076, 0095]; properties of the 3D printed biopolymer can be tuned by adjusting composition, temperature and/or concentration of the composition).
Regarding claim 2, Rogers discloses the method of claim 1, wherein the biopolymer solution is deposited into a counter solvent to solidify the biopolymer ([0018]; coagulating the biopolymer can include contacting with non-solvent, wherein the non-solvent can include an aqueous solvent such as water).
Regarding claim 3, Rogers discloses the method of claim 1, wherein the solvent is evaporated to solidify the biopolymer solution ([0124, 0131]; solvent can be removed via evaporation).
Regarding claim 5, Rogers discloses the method of claim 1, wherein the pre-alignment is achieved by tuning a concentration of the biopolymer and/or the solvent ([0095, 0127]; component concentrations), tuning a pressure applied to force the biopolymer solution through a nozzle ([0120, 0127]; extrusion pressure), tuning a diameter of the nozzle ([0119, 0121]; nozzle diameter), or a combination thereof.
Regarding claim 6, Rogers discloses the method of claim 1, wherein the biopolymer molecules are pre-aligned in the biopolymer solution using shear flow ([0095]), pressure ([0127]), modified ionic strength of the solvent ([0076]; providing different ions and ion combination in the solvent would result in different ionic strengths), or modified pH of the solvent ([0076]; providing different ions and ion combination in the solvent would result in different pH values).
Regarding claim 7, Rogers discloses the method of claim 1, wherein the biopolymer solution is deposited using 3D printing, extrusion or casting ([0118]).
Regarding claim 8, Rogers discloses the method of claim 1, wherein the one or more conditions comprise chemical or physical properties of the biopolymer ([0095]; concentration and/or viscosity of the biopolymer), properties of the biopolymer solution ([0099]), geometry or mechanics of an additive manufacturing process ([0121]; desired length can depend on the print path and/or the geometry of the structure being fabricated), or a combination thereof.
Regarding claim 9, Rogers discloses the method of claim 8, wherein the chemical or physical properties of the biopolymer comprise molecular weight ([0109]), molecular branching ([0041]), or degree of substitution ([0041]).
Regarding claim 10, Rogers discloses the method of claim 8, wherein the properties of the biopolymer solution comprise viscosity of the solution ([0095]) or concentration of the biopolymer ([0095]).
Regarding claim 11, Rogers discloses the method of claim 8, wherein the geometry or mechanics of the additive manufacturing process comprise geometry of a nozzle ([0121]; diameter of the nozzle), geometry of an extrusion hole of the nozzle ([0121]; diameter of the nozzle), motion of the nozzle ([0121]; print path), pressure ([0120]), or rate of extrusion ([0119]; print speed).
Regarding claim 12, Rogers discloses the method of claim 1, further comprising additional modification of the biopolymeric material ([0018]).
Regarding claim 13, Rogers discloses the method of claim 12, wherein the additional modification comprises dehydration ([0156]; freeze drying).
Regarding claim 14, Rogers discloses the method of claim 12, wherein the additional modification is performed after solidification of the biopolymer ([0156]).
Regarding claim 15, Rogers discloses the method of claim 1, wherein the biopolymer comprises chitin, chitosan, cellulose, lignin, collagen, alginate, agarose, silk fibroin, or a combination thereof ([0007]).
Regarding claim 16, Rogers discloses the method of claim 1, wherein the solvent is an organic solvent ([0112]; solvent may include organic co-solvent).
Regarding claim 17, Rogers discloses the method of claim 1, wherein the tunable properties of the biopolymeric material comprise shape or morphology ([0121]) or solvent content ([0091]).
Regarding claim 18, Rogers discloses the method of claim 1, wherein the biopolymer solution further comprises additional components ([0099]; one or more additives).
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (US 20190275199 A1; hereafter Rogers), in view of Van Zak et al. (US 20190232551 A1).
Regarding claim 4, Rogers discloses the method of claim 3.
Rogers does not explicitly disclose heat or pressure is used to evaporate the solvent.
However, in the analogous art Van Zak teaches an additive manufacturing method to produce a biopolymeric material ([0003, 0006]) using a composition comprising a biopolymer and a solvent ([0007]; biopolymer, such as pectin, in water solvent), wherein heat ([0131]; curing the object involves evaporating by heating) or pressure ([0034, 0131]; curing the object involves evaporating by increasing air flow on the object) is used to evaporate the solvent.
Rogers and Van Zak are both considered to be analogous to the claimed invention because they are in the field of additive manufacturing with biopolymers. Therefore, it would have been obvious to the person in the ordinary skill in the art before the effective filing date of the invention to modify the method of Rogers with the teachings of Van Zak to provide heat or pressure is used to evaporate the solvent. Use of known technique to improve similar devices (methods, or products) in the same way supports a prima facie obviousness determination. See MPEP 2143 I(C). It is very well-known that a 3D printed objected can be cured by heat or pressure in order to solidify the printed material into its final shape.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yadavalli et al. (US 20210246575 A1) teaches tuning biopolymer fiber properties when forming 3D nanofiber scaffolds.
Ruan et al. (WO 2020237414 A1) teaches a bio-ink for 3D printing with a modified biopolymer.
Z. Chen et al. (NPL 1) teaches 3D printing of multifunctional hydrogels with a biopolymer.
Ali Nadernezhad et al. (NPL 2) teaches a nanocomposite bioinks for 3D printing comprising agarose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vipul Malik whose telephone number is (571)272-0976. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Susan Leong can be reached at (571)270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VIPUL MALIK/Examiner, Art Unit 1754
/SEYED MASOUD MALEKZADEH/Primary Examiner, Art Unit 1754
