Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response to Restriction/Election Requirement, filed 7 April 2026. No claims are amended therein. Upon finalization and entry of the Restriction/Election Requirement (see below), claims 1 - 13 will be available for active consideration.
Response to Restriction/Election
The Examiner acknowledges Applicants’ election, without traverse, of the invention of Group I, claims 1 - 13, in the Response filed on 7 April 2026. The Examiner further acknowledges Applicants’ election of the species defined as microparticles from the genus of additive for further examination.
Claims 14, 15, 17, 21, 23, 27, and 42 are hereby withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1 - 13 are under consideration to the extent that the additive is microparticles.
Rejections Pursuant to 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 rejected pursuant to 35 U.S.C. § 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites a limitation directed to the “additive” component if the biomaterial of the invention being provided in a concentration “from 0 to about 90% weight percent.” Thus, the limitation is reasonably read to encompass compositions without the additive (0%). However, claim 5 recites a dependency from claim 4, and claim 4 affirmatively recites a biomaterial “further comprising at least one additive.” As a consequence, claim 5 improperly expands the scope of claim 4 rather than reciting “a further limitation of the subject matter,” in violation of § 112(d).
Applicants may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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.
Claims 1 – 13 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2018/0142108 A1 to Lewis, J. and J. Muth, published 24 May 2018 (“Lewis ‘108”), in view of US 2019/0307923 A1 to Gatenholm, P., et al., published 10 October 2019 (“Gatenholm ‘923”), and Tigner, T., et al., Biomacromolecules 21: 454 – 463 (19 November 2019) (“Tigner (2019)”).
The Invention As Claimed
Applicants claim a foam biomaterial comprising a biomaterial ink, the biomaterial having an interconnected pore structure, with a porosity from about 10% to about 90%, wherein the interconnected pore structure is formed without use of sacrificial materials, wherein the biomaterial comprises a polymer and/or a protein, wherein the biomaterial further comprises microparticles, wherein the microparticles are provided in a concentration from 0 to about 90% wgt, wherein the foam biomaterial is crosslinked or solidified through physical, ionic, thermal, chemical, enzymatic, photo crosslinking, or combinations thereof, wherein the foam biomaterial is adhered to a medical device or an implantable material, wherein the interconnected pore structure supports cellular infiltration, tissue remodeling, tissue regeneration, and/or tissue fidelity and stability, wherein the foam biomaterial has a Young's modulus from 1 kPa to 100 MPa, wherein the foam biomaterial is capable of sustaining 50% strain for 10 cycles without breaking, wherein the interconnected pore structure comprises a plurality of interconnected pores having a median diameter from about 20 to about 2,000 µm, wherein the foam biomaterial has a density from about 0.01 to about 1.5 g/mL, and wherein the foam biomaterial has a complex viscosity from about 1 Pa·sec to about 10 Pa·sec at 30° C.
The Teachings of the Cited Art
Lewis ‘108 discloses foam ink compositions for printing porous structures comprises stabilizing particles and gas bubbles dispersed in a solvent, the compositions including a porosity of at least about 40 vol. % (see Abstract), wherein the foam ink compositions can be readily patterned in three-dimensions by 3D printing (see ¶[0022]), wherein the stabilizing particles may comprise any of a number of inorganic or organic materials that can be prepared having a suitable interfacial energy, including polymers (see ¶[0025]), wherein the stabilizing particles have an average particle size in the range of about 1 nm to about 10 µm (see ¶[0029]), wherein the stabilizing particles may be present in the foam ink composition at a concentration of from about 20 to about 50 vol % (see ¶[0030]), wherein the gas bubbles are present in the foam ink composition at a concentration of from about 40 to about 80 vol % (see ¶[0031]), wherein, in addition to the stabilizing particles, gas bubbles and solvent, the foam ink compositions may further include a non-gelled polymer precursor, or a binder (see ¶[0032]), wherein a sintering step may be carried out to sinter the stabilizing particles into a sintered material that includes a population of pores created by the gas bubbles (see ¶[0038]), wherein the sintered material also includes open porosity (interconnected pores) (see ¶[0041]), wherein FIG. 6E depicts data from oscillatory tests of an exemplary foam ink composition at various periods during the synthesis process, including a plot labeled “Foam ink” representing the disclosed ready-to-print foam composition, the plot providing a measure of the elastic modulus of the foam ink derived from the plateau region of the stress-strain plot, with a value of approximately 105 Pa [100 MPa] (see ¶[0063]), and wherein FIG. 7C illustrates density in the range of approximately 10 to approximately 1000 kg/m3 [0.01 – 1 g/mL] for the disclosed foam ink compositions, plotted as elastic modulus versus density space coverage (see ¶[0065]). The reference does not disclose a foam biomaterial with complex viscosity from about 1 Pa·sec to about 10 Pa·sec at 30° C. The teachings of Gatenholm ‘923 and Tigner (2019) remedy that deficiency.
Gatenholm ‘923 discloses preparation of bioinks that can be 3D bioprinted with or without human cells and wherein the bioink can be additionally supplemented by other biopolymers that provide cross-linking (see Abstract), wherein gelatin methacrylate can be used as a cross-linkable biopolymer that can impart improved rheological properties as hydrogels in the bioink (see ¶[0015]; see also, ¶[0028]).
Tigner (2019) discloses a comparison among various cross-linkable hydrogels for use in bioink printing wherein the comparison demonstrated that gelatin-methacryloyl (GelMA) yielded inks at lower stress, were more easily extruded, and produced smoother ink filaments for 3D printing (see Abstract), wherein GelMA has been commonly employed as a macromer component in extrudable bioink formulations because GelMA’s naturally derived amino acid sequence affords bioinks with advantageous enzymatic degradability and integrin binding domains so that chemical cross-linking via a chain-growth polymerization reaction enables the production of hydrogel matrices with controllable mechanical properties (see p. 454, 1st col., 2nd para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare foam ink compositions for printing porous structures comprises stabilizing particles and gas bubbles dispersed in a solvent, the compositions including a porosity of at least about 40 vol. %, wherein the foam ink compositions can be readily patterned in three-dimensions by 3D printing, wherein the stabilizing particles may comprise any of a number of inorganic or organic materials that can be prepared having a suitable interfacial energy, including polymers, wherein the stabilizing particles have an average particle size in the range of about 1 nm to about 10 µm,
wherein the stabilizing particles may be present in the foam ink composition at a concentration of from about 20 to about 50 vol %, wherein the gas bubbles are present in the foam ink composition at a concentration of from about 40 to about 80 vol %, wherein a sintering step may be carried out to sinter the stabilizing particles into a sintered material that includes a population of pores created by the gas bubbles, wherein the sintered material also includes open porosity (interconnected pores), wherein FIG. 6E depicts data from oscillatory tests of an exemplary foam ink composition at various periods during the synthesis process, including a plot labeled “Foam ink” representing the disclosed ready-to-print foam composition, the plot providing a measure of the elastic modulus of the foam ink derived from the plateau region of the stress-strain plot, with a value of approximately 105 Pa [100 MPa], and wherein FIG. 7C illustrates densities in the range of approximately 10 to approximately 1000 kg/m3 [0.01 – 1 g/mL] for the disclosed foam ink compositions, as taught by Lewis ‘108, and wherein the foam bioink comprises gelatin methacrylate as a hydrogel base for the bioink, consistent with the teachings of Gatenholm ‘923 and Tigner (2019). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of the reference to the effect that the disclosed foam ink compositions can be readily patterned in three-dimensions by 3D printing (see ¶[0022]), and that bioinks comprising GelMA are capable of cross-linking, which process enhances the rheological properties of bioprinted constructs, with tunable physical properties.
With respect to those claims that recite quantitative values, or ranged of quantitative values (see, for example, claims 1, 6, 9, 12), the Examiner notes that the reference does not disclose specific values or ranges of values that are exactly congruent with the recited limitations. However, it is the Examiner’s position that the cited art teaches a range of values that significantly overlaps with the claimed values and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
With respect to claim 2 which recites a limitation directed to the pore structure of the foam compositions being formed without sacrificial materials, the reference discloses that the pores are created by the bubbles in the foam composition (see ¶[0038]).
With respect to claim 4, reciting a claim limitation directed to an additive in the form of microparticles, the Examiner notes that the cited reference, although disclosing “stabilizing particles,” does not characterize these particles as being “microparticles.” However, the reference discloses a particle size range (about 1 nm to about 10 µm) that would necessarily encompass a particle size distribution including microparticles.
Claim 6 recites limitations directed to processes for crosslinking or solidifying the foam biomaterial. In this regard, the Examiner notes that the reference discloses a sintering step that stabilizes the particles into a sintered material that includes a population of pores created by the gas bubbles (see ¶[0038]). It is the Examiner’s position that the sintering process effectively serves to harden or solidify the foam material, thus reading on this limitation.
Claim 7 recites a limitation directed to the foam biomaterial being “adhered to a medical device or an implantable material.” It is the Examiner’s position that the claim is directed to an intended use of the foam biomaterials of the invention and not to structural or compositional features of the inventive composition. Because claim 1 is directed to a composition of matter, its subject matter must be distinguished from the prior art by its structure or composition. Cf. Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is, not what a device does.’’). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. Cf Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020) (discussing effect of intended use recitations in claim preamble).
Claim 8 recites a limitation directed to the pore structure of the foam biomaterial supporting process such as cell infiltration, among other. It is the Examiner’s position that one of ordinary skill in the relevant art would recognize that the capacity of the foams to support such processes would be a direct function of the porosity and pore sizes of the foam. In light of the fact that the reference explicitly discloses foam compositions with the same range of total porosities and pore sizes as claimed would necessarily support such processes in vivo.
Claim 10 recites a limitation directed to the foam biomaterial being “capable of” sustaining 50% strain for 10 cycles without breaking. The cited reference does not directly address such a mechanical property. However, given that the reference explicitly discloses foam compositions with the same range of total porosities and pore sizes as claimed would necessarily display mechanical properties that would read on the limitation at issue.
With respect to claim 13, which claim recites a limitation directed to the complex viscosity of the foam bioinks of the invention, the Examiner notes that the cited references do not specifically address such viscosities. However, it is the Examiner’s position that a foam bioink prepared according to the teachings of the cited art, comprising the same range of total porosities and pore sizes, prepared with the same loading of microparticles with the same average particle sizes and at the same loadings, and comprising the same cross-linkable GelMA hydrogel would necessarily display complex viscosities reading on claim 13.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 - 13 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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