DETAILED ACTION
Receipt is acknowledged of applicant’s Response to Restriction Requirement filed 6/11/2026.
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 .
Status of the Claims
Claims 1-34 remain pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 6/1/2026 is acknowledged.
Claims 20-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Accordingly, claims 1-19 are currently under examination.
Claim Objections
Claims 4, 7, 12 and 14 are objected to because of the following informalities: the claims recite various acronyms, e.g., PVA, PEG, PEGDA, PEL-MA, etc. The acronyms are defined in the specification, however, when an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “polyvinyl alcohol (PVA)” and then recite only the acronym in subsequent reiterations.
Claim 7 is objected to because of the following informalities: the claim recites, “and/or one or more functionalized alginates selected form the group consisting of... or combination thereof”. The claim sets out that “one or more” functionalized alginates are permitted. Thus, the language “or combination thereof” is redundant and, as such, it is suggested that “or combination thereof” is deleted form the claim.
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 2, 4, 6, 14, 16-19 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.
Regarding claims 2, 6, 16, 17, 18 and 19, the phrases "preferably", “more preferably” and “most preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, the claim recites, “a non-biodegradable polymeric material selected form the group comprising or consisting of PVA”. The phrase “selected from the group comprising” is indefinite because the limitation uses improper Markush language. MPEP 2117(I) states, “Claim language defined by a Markush grouping requires selection from a closed group "consisting of" the alternative members”. Accordingly, the metes and bounds of the claim are unclear.
Claim 14 recites, “wherein said immunoprotective material comprises or further comprises..”. An immunoprotective material is set out in parent claim 11. The claim 14 is indefinite because it is unclear whether the “acrylated zwitterionic monomer...” is the immunoprotective material or if the “acrylated zwitterionic monomer...” is an additional component.
Claim 14 recites, “an acrylated zwitterionic monomer (SBMA) and PEGDA”. The instant specification states, “an acrylated zwitterionic monomer sulfobetaine methacrylate (SBMA) and/or PEGDA” ([0011]). The specification implies that sulfobetaine methacrylate (SBMA) and PEGDA are acrylated zwitterionic monomers, however the claim as written implies that “SBMA” is the acronym for “an acrylated zwitterionic monomer” and PEGDA is an additional component. It is suggested that the claim is amended to correspond with the language in the specification, e.g., an acrylated zwitterionic monomer comprising sulfobetaine methacrylate (SBMA) and/or PEGDA.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5-12 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. (WO 2021/081672 A1, pub. May 6, 2021, eff. filing date of Nov. 1, 2019, hereafter as “Beyer”).
The instant claims are drawn to a bioprinted selectively permeable tissue fiber comprising a solid core, at least one annulus layer surrounding said solid core comprising at least one biological material embedded in a cross-linkable biocompatible material, and at least one external shell layer surrounding said at least one annulus layer.
It is noted that the limitation "bioprinted" is considered a product-by-process limitation and, as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claims 1 and 5, Beyer teaches core shell fiber structures including multi-shell structures which are produced via three-dimensional printing ([0002] and [0012]). Beyer teaches embodiments having a solid core, wherein the core and shell(s) have variable materials [0046] and [0067]; Fig. 14). Beyer teaches the fiber materials comprise a hydrogel such as alginate, collagen, fibrinogen, gelatin, chitosan, and hyaluronic acid based gels ([00139]). Beyer teaches that the hydrogel is cross-linkable ([00139]). Beyer further teaches that the fibers can include any mammalian cell type or active agents ([00145] and [00151]-[0157]).
Beyer is silent to a particular embodiment combining all of the elements, however it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine each of the elements with a reasonable expectation of success because Beyer teaches that each of the elements are suitable for the invention.
Regarding the limitation "selectively permeable", said limitation is a property of the fiber itself. Beyer teaches the same fiber core and shell materials as claimed/disclosed and, as such, the same materials would be expected to behave in the same manner. A composition and its properties are inseparable (MPEP 2112.01).
Regarding instant claim 2, Beyer teaches the elements discussed above. Beyer further teaches that the core (first input material) can be crosslinked (i.e., reinforced/providing increased mechanical strength) ([0046]). It is noted that the usage of “preferably” in the claim. Due to the indefinite language, the limitations following the phrase are being interpreted as optional.
Regarding instant claim 3, Beyer teaches the elements discussed above. Beyer further teaches that the core (first input material) can be crosslinked (i.e., reinforced/providing increased mechanical strength) ([0046]). It is noted the phrase “cross-linked from the inside out” is considered a product-by-process limitation and as such, determination of patentability is based on the product itself, not by the method in which it is made. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113).
Regarding instant claim 6, Beyer teaches the elements discussed above. Beyer further illustrates that a biological material is homogenously dispersed throughout a shell layer (Example 1; Fig. 12). Figures 12 and 14 also illustrate segmented shell embodiments where the composition in each shell segment is varied. It is noted that the usage of “preferably” in the claim. Due to the indefinite language, the limitations following the phrase are being interpreted as optional.
Regarding instant claim 7, Beyer teaches the elements discussed above. Beyer teaches the fiber materials comprise a hydrogel such as alginate, collagen, fibrinogen, gelatin, chitosan, and hyaluronic acid based gels ([00139]). Beyer further teaches the inclusion of polyethylene glycol (PEG) and methacrylated hydrogels such as gelatin methacrylate (GEL-MA) or polyethylene (glycol) diacrylate-based (PEG-DA) hydrogels which are used in cell biology due to their ability to crosslink in presence of free radicals after exposure to UV light and due to their inertness to cells ([00139]-[00141]). Beyer also teaches additional components that support the viability of living cells including, laminin, fibrin, hyaluronic acid, poly(ethylene) glycol based gels, gelatin, chitosan, agarose, fibronectin, thrombospondin, glycosaminoglycans (GAG) (e.g., hyaluronic acid, chondroitin-6-sulfate, dermatan sulfate, chondroitin-4-sulfate, or keratin sulfate), deoxyribonucleic acid (DNA), adhesion glycoproteins, and collagen (e.g., collagen I, collagen II, collagen III, collagen IV, collagen V, collagen VI, or collagen XVIII) ([00142]).
Regarding instant claim 8, Beyer teaches the elements discussed above. Beyer also teaches the at least one biological material comprises living cells, e.g., cells from endocrine and exocrine glands including pancreas (alpha, beta, delta, epsilon, gamma), liver (hepatocyte, Kuppfer, Stelate, sinusoidal cells), thyroid (Follicular cells), pineal gland (pinealocytes), pituitary gland (somatotropes, Lactotropes, gonadotropes, corticotropes, and thyrotropes), thymus (thymocytes, thymic epithelial cells, thymic stromal cells), adrenal gland (cortical cells, chromaffin cells), ovary (granulosa cells), testis (Leydig cells) and gastrointestinal tract (enteroendocrine cells - intestinal, gastric, pancreatic) ([0051]). Beyer further teaches the at least one biological material comprises a cell population expressing/secreting a biologically active agent ([0051]). Beyer also teaches the invention can incorporate any mammalian cell type, including but not limited to stem cells (e.g., embryonic stem cells, adult stem cells, induced pluripotent stem cells) ([00145]-[00146]).
Regarding instant claim 9, Beyer teaches the elements discussed above. Beyer also
teaches the at least one biological material comprises a cell population expressing/secreting a biologically active agent, e.g., an exosome ([0051]).
Regarding instant claim 10, Beyer teaches the elements discussed above. The instant specification describes immunoprotective materials and pro-vasculogenic materials at [0011] and [0012]. Beyer teaches the particular immunoprotective materials and pro-vasculogenic materials, alginate, chitosan, collagen, gelatin, hyaluronic acid, fibrin, decellularized ECM, methacrylated hydrogels such as gelatin methacrylate (GEL-MA) or polyethylene (glycol) diacrylate-based (PEG-DA) hydrogels, etc. ([0050], [00139], [00141] and [00142]).
Regarding instant claim 11, Beyer teaches the elements discussed above. Beyer is silent to a particular embodiment comprising an outer external shell layer comprising pro-vasculogenic materials and an inner external shell layer comprising immunoprotective materials. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an outer external shell layer comprising pro-vasculogenic materials and an inner external shell layer comprising immunoprotective materials with a reasonable expectation of success because Beyer teaches each of the individual components and one of ordinary skill would have been able to optimize the particular configuration depending on the desired effects and properties by way of routine experimentation. MPEP 2143 states, "[a] person of ordinary skill is also a person of ordinary creativity, not an automaton," and "the final step [of the claimed invention] is merely the logical result of common sense application of the maxim ‘try, try again’”.
Regarding instant claim 12, Beyer teaches the elements discussed above. Beyer teaches the particular immunoprotective materials, alginate, chitosan, hyaluronic acid, methacrylated hydrogels such as gelatin methacrylate (GEL-MA) or polyethylene (glycol) diacrylate-based (PEG-DA) hydrogels, etc. ([00139], [00141] and [00142]).
Regarding instant claim 15, Beyer teaches the elements discussed above. The instant specification describes immunoprotective materials and pro-vasculogenic materials at [0011] and [0012]. Beyer teaches the particular pro-vasculogenic materials, fibrin, collagen, gelatin, hyaluronic acid, decellularized ECM, and methacrylated hydrogels such as gelatin methacrylate (GEL-MA) ([0050], [00139], [00141] and [00142]).
Regarding instant claim 16, Beyer teaches the elements discussed above. Beyer also teaches an overall fiber diameter of about 0.01 mm to about 5 mm ([0026]). Beyer illustrates particular fibers having overall diameters of 360 microns (0.36 mm), 785 microns (0.785 mm), 1400 microns (1.4 mm) and 1460 microns (1.46 mm) (Fig. 15).
Regarding instant claim 17, Beyer teaches the elements discussed above. Beyer also teaches core diameters of about 10 microns (0.01 mm) to about 5 mm ([0026]). Beyer illustrates particular fibers having core diameters of 200 microns (0.2 mm), 385 microns (0.385 mm), 218 microns (0.218 mm) and 922 microns (0.922 mm) (Fig. 15).
Regarding instant claim 18, Beyer teaches the elements discussed above. Beyer also teaches sheath flow channels can have a width or diameter that ranges from about 10 microns to about 5 mm, such as about 25, 50, 75 or 100 microns, or such as about 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 2.0 or 3.0 mm ([0098]). Beyer also illustrates particular fibers having shell layers with thicknesses of 160 microns (0.16 mm) and 400 microns (0.4 mm) (Fig. 15). While Beyer does not teach a particular embodiment having an annulus layer with a thickness of about 0.01 mm to 0.4 mm, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the diameter/thickness of each layer by way of routine optimization with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Beyer teaches the general conditions of the claim and it is the normal desire of scientist and artisans to improve upon what is already generally known and determine in a disclosed set of ranges the optimum combination of ranges. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (MPEP 2144.05(II)(A)).
Regarding instant claim 19, Beyer teaches the elements discussed above. Beyer also teaches that the core and shell diameters can have a width or a diameter of about 10 microns (0.01 mm) to about 5 mm ([0093]). Beyer illustrates particular fibers having a shell layer with a thickness of 160 microns (0.16 mm) (Fig. 15).
Thus, the teachings of Beyer render the instant claims prima facie obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over
Beyer et al. (WO 2021/081672 A1, pub. May 6, 2021, eff. filing date of Nov. 1, 2019, hereafter as “Beyer”), as applied to claims 1 and 2 above, in view of Bendtsen et al. (“Development of a novel alginate-polyvinyl alcohol-hydroxyapatite hydrogel for 3D bioprinting bone tissue engineered scaffolds”, Journal of Biomedical Materials Research, May 2017, Vol. 105A, Iss. 5, pp. 1457-1468; hereafter as “Bendtsen”).
The instant claims are described above.
Beyer teaches the elements discussed above including polyvinyl alcohol ([00158] and [00190]), but does not teach that the polyvinyl alcohol is a solid core material.
Bendtsen teaches an alginate-polyvinyl alcohol-hydroxyapatite hydrogel for 3D printing bone tissue engineered scaffolds (title). Bendtsen teaches that PVA-HA played a significant role in the viscosity and printability of the formulations as well as cell viability after 3D printing (page 1466, right col., last para.). Bendtsen also teaches that the scaffold has the potential to provide a suitable environment for cells for in vitro culture (page 1466, right col., last para.).
Beyer and Bendtsen are drawn to 3D-printed constructs comprising hydrogels and cells for the purpose of tissue regeneration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include polyvinyl alcohol as a solid core material in the invention of Beyer, as suggested by Bendtsen, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Bendtsen teaches that polyvinyl alcohol is effective as a material for 3D-printing biological constructs and suitable for encapsulating cells and the proliferation thereof.
Thus, the combined teachings of Beyer and Bendtsen render the instant claim prima facie obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over
Beyer et al. (WO 2021/081672 A1, pub. May 6, 2021, eff. filing date of Nov. 1, 2019, hereafter as “Beyer”), as applied to claims 1, 10 and 12 above, in view of Lee (US 2017/0198275 A1, Jul. 13, 2017, hereafter as “Lee”).
The instant claims are described above.
Beyer teaches the elements discussed above including methacrylated hydrogels ([00141]).
Beyer is silent to a functionalized alginate.
Lee teaches 3D-printed miniature biological constructs comprising suspended cells in a hydrogel (title; abstract). Lee teaches suitable hydrogels including alginate, methacrylated alginate, chitosan, hyaluronic acid, collagen, etc. ([0028]). In a particular embodiment, Lee teaches methacrylated alginate as the hydrogel ([0031] and [0042]; Example 1).
Beyer and Lee are drawn to 3D-printed constructs comprising hydrogels and cells for the purpose of tissue regeneration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a functionalized alginate such as methacrylated alginate in the invention of Beyer, as suggested by Lee, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Lee teaches that methacrylated alginate is effective as a hydrogel material for 3D-printing biological constructs, suspending cells, and growing cells and also because Lee teaches hydrogels including alginate, methacrylated alginate, chitosan, hyaluronic acid, collagen are functional equivalents. Substituting equivalents known for the same purpose is prima facie obvious (MPEP 2144.06 (II)).
Thus, the combined teachings of Beyer and Lee render the instant claim prima facie obvious.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over
Beyer et al. (WO 2021/081672 A1, pub. May 6, 2021, eff. filing date of Nov. 1, 2019, hereafter as “Beyer”), as applied to claims 1, 10 and 11 above, in view of Vasileva et al. (BG 112942 A, Nov. 30, 2020, machine translation, hereafter as “Vasileva”).
The instant claims are described above.
Beyer teaches the elements discussed above including methacrylated hydrogels such as PEG-DA ([00141]).
Beyer is silent to an acrylated zwitterionic monomer (SBMA) and PEGDA.
Vasileva teaches polyzwitterion hydrogels for dressings for treatment of chronic and necrotic wounds (abstract). Vasileva teaches that the polyzwitterion hydrogels have ultra-low bioadhesion and antibiofilm-forming properties as well as antibacterial properties (abstract). Vasileva teaches the particular hydrogel, a polyvalerite network of poly (sulfobetaine methacrylate) (PSBMA) and crosslinking segments of polyethylene glycol diacrylate (PEGDA) (page 6, 4th paragraph). Vasileva teaches PSBMA as having an improved cell viability effect (page 8, 7th paragraph).
Beyer and Vasileva are drawn to products comprising hydrogels for the purpose of tissue repair/regeneration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an acrylated zwitterionic monomer such as SBMA and PEGDA in the invention of Beyer, as suggested by Vasileva, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Vasileva teaches that a hydrogel comprising PSBMA and PEGDA is effective as a hydrogel material for wound healing/supporting cellular growth and repair.
Thus, the combined teachings of Beyer and Vasileva render the instant claim prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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