DETAILED ACTION
Summary
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments and claim amendments filed on January 21, 2026 have been entered into the filed. Currently claims 1 and 13 are amended and claims 3-4, 10-11, 15, and 28-68 are cancelled, resulting in claims 1-2, 5-9, 12-14, and 16-27 pending for examination.
It is noted that “recreates” in the amended claim 1 is being treated by the Merriam-Webster dictionary definition “to create again”, and therefore is interpreted as requiring the textile substrate and the matrix to be an identical copy of the three-dimensional spatial distribution of the at least one structural molecule and the pores of the biological material of interest.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-9, 12-14, and 16-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claim 1, the specification does not provide support for the textile substrate and the matrix recreating the three-dimensional spatial distribution of the at least one structural molecule and the pores, respectively, of the biological material of interest as recited in lines 20-22 and 24-28. Support for the amendment is alleged to be in paragraphs [0117] and [0129] of the specification. Paragraph [0117] of the instant specification describes the use of MADAME to map spatial and temporal properties intrinsic to nature’s smart materials. Paragraph [0117] further describes that the patterns intrinsic to such materials are then recreated using recursive logic. This recursive logic provides a basis for computer coding algorithms and computer-controlled Jacquard looms to enable creation of physical embodiments. Therefore the “recreation” referred to in paragraph [0117] is recreating the structure of the natural material in the computer after mapping, and does not refer to the structure of the physical embodiment as used in the claim.
Paragraph [00129] of the instant specification discusses emulating nature systems. As discussed in previous office actions, “emulating” does not necessarily require the resulting structure of the textile physical embodiment to be identical to the biological material of interest as long as it imitates or mimics the biological material, particularly in mechanical property, material property, and/or structural property. However, as asserted above, “recreates” is interpreted as requiring the structure of the resulting textile be identical to that of the biological material. Therefore a disclosure of the textile emulating the biological material is not sufficient to provide support for the textile material recreating the biological material. Therefore the specification as filed does not provide support for the textile substrate and the matrix recreating the three-dimensional spatial distribution of the at least one structural molecule and the pores, respectively, of the biological material of interest.
Claims 2, 5-9, 12-14, and 16-27 are also rejected under 35 U.S.C. 112(a) based on their dependency from claim 1, rejected above.
Claims 1-2, 5-9, 12-14, and 16-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a smart material comprising: a composite textile that includes a textile substrate formed from a plurality of fibers assembled in a fiber assembly pattern and a material , does not reasonably provide enablement for wherein. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Claim 1 is directed to a smart material comprising a composite textile that includes a textile substrate formed from a plurality of fibers assembled in a fiber assembly pattern and a material deposited via an additive manufacturing technique. The composite textile includes a gradient in at least one of mechanical property, material property, or structural property and/or exhibits a change in at least one mechanical property, material property, or structure in response to at least one external stimulus. The fiber assembly pattern and the additive manufacturing pattern recreate a three-dimensional spatial distribution of at least one structural molecule and pores of a biological material of interest. Claim 1 largely provides product by process limitations and functional limitations and does not describe the actual structure of the fiber pattern and additive manufacturing pattern (Wands Factors (A) and (B)).
As discussed previously in the prior art rejections, the mimicking/emulating of biological materials with fiber structure is known in the art (see e.g., Guilak paragraphs [0085]-[0086], [0095]-[0098], [0117], [0122] for descriptions of a fiber scaffold mimicking the behavior and mechanical properties of a target tissue and Tate paragraphs [0012], [0027]-[0036], [0042] for pore hierarchies similar to native biological materials). The prior art methods do not use the same imaging process as discloses by the instant disclosure and therefore do not contemplate how an algorithm based on imagining of a biological material can be translated into physical weaving and 3D printing patterns such that the resulting composite material recreates the biological material of interest (Wands Factors (C) and (D)).
Based on paragraph [0117] of the instant specification it appears that the biological material can be recreated onto the computer through the described imaging method, however how the algorithm actually translates to weaving and 3D printing patterns that provide a physical textile composite material that recreates the biological material is not described. The weaving pattern resulting from the imaging algorithm is not disclosed, the 3D printing pattern resulting from the imaging algorithm is not disclosed, the resulting textile fiber structure is not disclosed, the resulting porosity structure for 3D printed matrix is not disclosed, and whether the resulting physical structure recreates the biological structure is not compared. The instant specification frequently refers to the final structure being based on and emulating the biological material (see e.g., instant specification paragraphs [0004], [0006]-[0011], [0026], [0027], [0033], [0054], [00116], [00118], [00124], [00129] not recreating as is claimed (Wands Factor (F)).
The instant specification provides examples starting at paragraph [00116] of the instant specification. The Examples are detailed concerning the imaging process, however does not describe the actual production of the composite material (Wands Factor (G)).
The quantity of experimentation that would be required to make the invention is unclear. The instant disclosure describes in detail the imaging process, but does not go into detail about how the algorithm that results from the imaging process is translated into weaving and 3D printing patterns that recreate the biological material. The disclosure also does not go into detail as to how these patterns are physically recreated, particularly with the issues of complex fibrous systems and scale which are present in biological materials. As discussed above, the prior art does not utilize an imaging system as the instant disclosure does. Therefore, the predictability of the art and the quantity of experimentation that would be needed to create the physical product cannot be determined (Wands Factors (E) and (H)).
In sum, the instant disclosure goes into detail concerning the imaging process, but does not describe in adequate detail how the algorithm resulting from the imaging process physically translates into a composite material that recreates a three-dimensional spatial distribution of at least one structural molecule and the pores of a biological material of interest as claimed in claim 1.
Claims 2, 5-9, 12-14, and 16-27 are also rejected under 35 U.S.C. 112(a) based on their dependency from claim 1, rejected above.
Response to Arguments
Response – Claim Rejections 35 USC §103
The rejections of:
claim(s) 1-2, 8-9, 12-14, and 16-18 under 35 U.S.C. 103 as being unpatentable over Guilak (US 2007/0041952) in view of Tate (US 2009/0053109);
claim(s) 5-7 under 35 U.S.C. 103 as being unpatentable over Guilak (US 2007/0041952) in view of Tate (US 2009/0053109) and further in view of Knothe (WO 2016/203409); and
claim(s) 19-27 under 35 U.S.C. 103 as being unpatentable over Guilak (US 2007/0041952) in view of Tate (US 2009/0053109) and further in view of Knothe Tate (US 2016/0193069)
have been withdrawn in light of the amendments to the claims filed January 21, 2026.
In light of the amendments to the claims filed January 21, 2026 new rejections under 35 U.S.C. 112(a) new matter and scope of enablement have been applied above.
Applicant’s arguments with respect to claim(s) 1 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
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.
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LARISSA ROWE EMRICH
Examiner
Art Unit 1789
/LARISSA ROWE EMRICH/Examiner, Art Unit 1789