DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2024 has been considered by the examiner.
Status of the Claims
The response and amendment filed 02/04/2026 is acknowledged.
Claims 1-20 are pending.
Applicant’s election of Group I, claims 1-15 in the reply filed on 02/04/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of species photoinitiator and wherein the biomaterial is in the form of a foam in the reply filed on 02/04/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The species election for the form of the composition has been withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Applicant indicates the elected species read on claims 1-2, 4-9, and 11-15.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/04/2026.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/04/2026.
Claims 1-2, and 4-15 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
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.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 6 and 14-15 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 pre-AIA the applicant regards as the invention.
Claim 6 includes the limitation of where the uncrosslinked plant-based biomaterial functionalized with reactive groups comprises at least 40% by weight of plant-based protein. The percent limitation is unclear to those skilled in the art.
The total weight is not clear since this percent may be calculated based on the total weight of the biomaterial composition, or the total weight of the uncrosslinked plant-based biomaterial component, or the total weight of the uncrosslinked plant-based biomaterial component functionalized with reactive groups that are operative to undergo a crosslinking reaction via free radical polymerization.
The skilled artisan further cannot determine what part of the whole the percent is measuring. For example, the skilled artisan may interpret this to mean the uncrosslinked plant-based biomaterial component of the composition further comprises at least 40% by weight of plant-based protein irrespective of whether the plant-based protein is functionalized with reactive groups. Alternatively, the skilled artisan may interpret this limitation to mean at least 40% of the material functionalized with reactive groups is a plant-based protein.
A review of the specification does not clarify these issues as there are no examples demonstrating how this percent was intended to be calculated.
This rejection may be overcome by inserting “further” before “comprises” and by deleting “at least 40% by weight of.”
Claims 14-15 do not clarify this issue.
Clarification is required.
Claim 7 is 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 pre-AIA the applicant regards as the invention.
Claim 7 includes the limitation of where the biomaterial composition is further mixed with cells to form a bioink prior to undergoing free radical polymerization. The claim reads as a method of using the composition of claim 1. Claiming a product and process in the same claim is indefinite. See MPEP 2173.05(p), II. Moreover, the presence of cells is contingent, i.e., prior to undergoing free radical polymerization. The skilled artisan cannot determine whether free radical polymerization, i.e., crosslinking, is required. If the material is crosslinked, it will not include all of the limitations of claim 1 which requires an uncrosslinked material. Thus, claim 7 necessarily excludes crosslinked materials.
Consequently, the skilled artisan cannot understand if the claim was intended to require cells or not. This rejection may be overcome with “further comprising” language, e.g., where the biomaterial composition further comprises cells, and deleting “prior to undergoing free radical polymerization.”
Claim 7 is interpreted as a product claim reciting an intended use.
Clarification is required.
Claim 8 is 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 pre-AIA the applicant regards as the invention.
Claim 8 includes the limitation of where the bioink is used to biofabricate a construct; where the construct is cured either simultaneously or sequentially with the biofabrication. The claim reads as a method of using the composition of claim 7. Claiming a product and process in the same claim is indefinite. See MPEP 2173.05(p), II.
Further, it is not clear what “to biofabricate” means. It is not clear what “is cured” was intended to mean. Since it is not clear what “to biofabricate” means, it is not clear when curing is required to take place.
To the extent that “is cured” and/or “to biofabricate” means the plant based, functionalized, biomaterial is crosslinked, claim 8 would not require all of the limitations of claim 1 which requires an uncrosslinked material. Thus, claim 8 necessarily excludes crosslinked materials which have been cured or used for biofabrication of a construct.
Claim 8 is interpreted as a product claim reciting an intended use.
Clarification is required.
Claims 9 and 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 pre-AIA the applicant regards as the invention.
Claim 9 includes the limitation of where the biomaterial composition is in the form of a liquid foam prior to the free radical polymerization. The claim reads as a method of using the composition of claim 1. Claiming a product and process in the same claim is indefinite. See MPEP 2173.05(p), II.
Moreover, the presence of the foam form is contingent, i.e., prior to undergoing free radical polymerization. Since the claim only requires the structure of a foam form at some point prior to free radical polymerization, it may reasonably be construed as reading on compositions having forms other than foams when temporally distinct from the moment of free radical polymerization. This is a product claim. Thus, the skilled artisan cannot understand if the claim was intended to require a foam form or not for the purposes of understanding how to avoid infringement of the composition of claim 9. See MPEP 2173.02, II. This rejection may be overcome by deleting “prior to undergoing free radical polymerization.”
Claim 9 is interpreted as a product claim reciting an intended use.
Claim 11 includes the limitations of claim 9 without clarifying the issue.
Clarification is required.
Claim 10 is 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 pre-AIA the applicant regards as the invention.
Claim 10 includes the limitation of where the biomaterial composition is in the form of an unfoamed liquid prior to the free radical polymerization. The claim reads as a method of using the composition of claim 1. Claiming a product and process in the same claim is indefinite. See MPEP 2173.05(p), II.
Moreover, the presence of the unfoamed liquid form is contingent, i.e., prior to undergoing free radical polymerization. Since the claim only requires the structure of an unfoamed liquid form at some point prior to free radical polymerization, it may reasonably be construed as reading on compositions having forms other than unfoamed liquids when temporally distinct from the moment of free radical polymerization. This is a product claim. Thus, the skilled artisan cannot understand if the claim was intended to require an unfoamed liquid form or not for the purposes of understanding how to avoid infringement of the composition of claim 10. See MPEP 2173.02, II. This rejection may be overcome by deleting “prior to undergoing free radical polymerization.”
Claim 10 is interpreted as a product claim reciting an intended use.
Clarification is required.
Claim 11 is 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 pre-AIA the applicant regards as the invention.
Claim 11 includes the limitation of the biomaterial composition of Claim 9, where the liquid foam is mixed with cells to form a bioink. The claim reads as a method of using the composition of claim 1. Claiming a product and process in the same claim is indefinite. See MPEP 2173.05(p), II.
Moreover, the presence of the foam form and cells is contingent, i.e., prior to undergoing free radical polymerization. Thus, the skilled artisan cannot understand if the claim was intended to require the form of a liquid foam and the presence of cells in the foam for the purposes of understanding how to avoid infringement of claim 11 This rejection may be overcome by with further comprising language, e.g., wherein the liquid foam further comprises cells, in addition to clarifying claim 9.
Claim 11 is interpreted as a product claim reciting an intended use.
Clarification is required.
Claim 13 is 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 pre-AIA the applicant regards as the invention.
There is no antecedent basis for “the construct” in claim 13. Claims 1 and 12 refer to a composition rather than a construct. It is not clear what “the construct” was intended to refer to. The skilled artisan cannot determine what “total weight” is required to calculate the weight percent of the additive since the construct is undefined. Therefore, the weight percent required cannot be determined by one skilled in the art.
Clarification is required.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 13 depends from claim 12 which requires that the composition comprises at least one additive. However, claim 13 includes compositions wherein the additive is not present, i.e., wherein the additive has a concentration of 0 weight percent based on the total weight of the construct. Thus, claim 13 does not require all of the limitation of claim 12 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 5, 7, 8, 10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Nicoll, US 20110182957 A.
Nicoll teaches a biomaterial composition comprising a cellulose derivative polymer wherein an unprotected group on the cellulose derivative polymer backbone is substituted with a covalently bound photocrosslinkable group (Nicoll, entire document, e.g., claim 1 and claim 3). A cellulose derivative is a plant-based biomaterial. Applicable to claim 2: the composition further comprises a photoinitiator (Nicoll, e.g., claim 5). Applicable to claim 4: The material is crosslinkable to form a crosslinked biomaterial (Nicoll, entire document, e.g., claims 4 and 19). Applicable to claim 5: the material is suitable for the recited intended use, e.g., the material is able to support cell growth (Nicoll, e.g., Abstract and 0148). Applicable to claims 7 and 11: the material can be mixed with cells prior to polymerization (Nicoll, e.g., 0128). Applicable to claim 10: Nicoll does not teach a liquid foam form. Applicable to claim 8: the material is able to be cured to form an implant, i.e., construct (Nicoll, e.g., claims 17-18). Applicable to claim 12: Nicoll teaches the composition further comprising a peptide and biological factors (Nicoll, e.g., claim 12). Applicable to claims 12 and 13: Nicoll teaches the composition further comprising a peroxide, i.e., an oxygen generating material in an amount ranging from about 0.01 to about 4wt% (Nicoll, e.g., 0092).
Nicoll anticipates the subject matter of instant claims 1-2, 4, 5, 7, 8, 12, and 13.
Claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Shoseyov, US 20210138113 A1.
Shoseyov teaches a photoinitiated composition comprising a plant-based protein, i.e., plant derived collagen (Shoseyov, e.g., entire document, e.g., Abstract and claims, e.g., claims 8-12). The plant-based protein, i.e., collagen is modified with functional groups operable to undergo a crosslinking reaction via free radical polymerization, i.e., methacrylated (Shoseyov, e.g., claim 12 and 0015 and 0074). The functionalized collagen may be present in an amount of about 66% by weight based on the weight of the polymers in the material (Shoseyov, e.g., 0527, 10 mg/ml HA and 20 mg/ml collagen-MA in DMEM medium). The composition further comprises a photoinitiator (Shoseyov, e.g., claim 7). Applicable to claims 5, 7, and 11: The composition may contain cells (Shoseyov, e.g., 0226). The composition is able to be used according to the intended uses recited in claims 4, 5, 7, and 8. Applicable to claim 10: Shoseyov does not teach a foamed liquid form. Applicable to claims 12-13: the composition further comprises polysaccharides in an amount of about 1% by weight (10 mg/mL). See Shoseyov, e.g., 0527-0528. Applicable to claim 12: Shoseyov teaches the composition further comprising microspheres, calcium or phosphate or hydroxyapatite (Shoseyov, e.g., 0048). The composition may further comprise growth factors/biological factors/plasma protein/platelet rich plasma (Shoseyov, e.g., 0076-0082, 0241, and claims 26-27). Applicable to claim 15: the plant-based protein is derived from leaves (Shoseyov, e.g., 0098).
Shoseyov anticipates the subject matter of instant claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13 and 15.
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 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.
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 1-2, 4, 5, 7, 8, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Nicoll, US 20110182957 A and Attar, 20200237957 A1.
The teachings of Nicoll enumerated above teach a biomaterial composition according to claim 1 but do not expressly teach the composition in the form of a liquid foam prior to the free radical polymerization.
To the extent that claims 9 and 11 require a foam form, Attar teaches biomaterial compositions for tissue regeneration (Attar, e.g., 0002), wherein the composition is in the form of a foam (Attar, Title, Abstract, claims 0096-0098, 0114, 0119, 0127). The foam form enables production of crosslinked hydrogels having porous features, e.g., porous scaffold, which offer scaffold improvements such as encouraging cell infiltration and blood vessel formation (Attar, e.g., 0188 and 0287). Attar teaches crosslinking of the foam material imparts a porous nature on the resulting crosslinked scaffold which supports cells, improves cell attachment and motility compatibility (Attar, e.g., 0188) and the porous structure of the biomaterial makes it more structurally similar to the extracellular matrix of natural tissues (Attar, e.g., 0194 and 0199). Attar teaches the material seeded with cells (Attar, e.g., 0152 and 0320 and 0321 and 0324). Applicable to claims 5, 7, 11: Attar teaches cells may be seeded before or after crosslinking (Attar, e.g., 0326-0327). Applicable to claims 12-13: Attar teaches the addition of a polysaccharide, e.g., GAG, in an amount ranging from 0.5 to 10wt% to further enhance growth of cells (Attar, e.g., 0215).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify liquid compositions known from Nicoll so that the liquid is in the form of a foam prior to polymerization with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to improve Nicoll’s crosslinked biomaterial for tissue regeneration in the same way reported by Attar. For example, the skilled artisan would have expected this modification to encourage cell infiltration and blood vessel formation, improve cell attachment and cell mobility, and to configure the crosslinked biomaterial to be more structurally similar to the tissue site being treated. The skilled artisan would have had a reasonable expectation of success because both references teach biomaterials useful as scaffolds for cell seeding and tissue regeneration.
Accordingly, the subject matter of claims 1-2, 4, 5, 7, 8, and 9-13 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shoseyov, US 20210138113 A1 and Attar, 20200237957 A1.
The teachings of Shoseyov enumerated above teach a biomaterial composition according to claim 1 but do not expressly teach the composition in the form of a liquid foam prior to the free radical polymerization.
To the extent that claims 9 and 11 require a foam, Attar teaches biomaterial compositions for tissue regeneration (Attar, e.g., 0002), wherein the composition is in the form of a foam (Attar, Title, Abstract, claims 0096-0098, 0114, 0119, 0127). The foam form enables production of crosslinked hydrogels having porous features, e.g., porous scaffold, which offer scaffold improvements such as encouraging cell infiltration and blood vessel formation (Attar, e.g., 0188 and 0287). Attar teaches crosslinking of the foam material imparts a porous nature on the resulting crosslinked scaffold which supports cells, improves cell attachment and motility compatibility (Attar, e.g., 0188) and the porous structure of the biomaterial makes it more structurally similar to the extracellular matrix of natural tissues (Attar, e.g., 0194 and 0199). Attar teaches the material seeded with cells (Attar, e.g., 0152 and 0320 and 0321 and 0324). Applicable to claims 5, 7, 11: Attar teaches cells may be seeded before or after crosslinking (Attar, e.g., 0326-0327). Applicable to claims 12-13: Attar teaches the addition of a polysaccharide, e.g., GAG, in an amount ranging from 0.5 to 10wt% to further enhance growth of cells (Attar, e.g., 0215).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify liquid compositions known from Shoseyov so that the liquid is in the form of a foam prior to polymerization with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to improve Shoseyov’s crosslinked biomaterial for tissue regeneration in the same way reported by Attar. For example, the skilled artisan would have expected this modification to encourage cell infiltration and blood vessel formation, improve cell attachment and cell mobility, and to configure the crosslinked biomaterial to be more structurally similar to the tissue site being treated. The skilled artisan would have had a reasonable expectation of success because both references teach biomaterials useful as scaffolds for cell seeding and tissue regeneration.
Accordingly, the subject matter of claims 1-2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nicoll, US 20110182957 A and Hubbell, US 20040138329 A1.
The teachings of Nicoll enumerated above teach a biomaterial composition according to claim 1 but do not expressly teach the composition comprising plant-based protein.
Hubbell teaches zein may be used as a photopolymerizable macromer (Hubbell, e.g., 0108-0109) like cellulose derivatives (Hubbell, e.g., 0106-0107), in biomaterials for encapsulation of cells and tissue (Hubbell, e.g., 0024-0027), and wherein the material is non-toxic and biocompatible for implantation (Hubbell, e.g., 0006) as a hydrogel (Hubbell, e.g., 0115). Thus, photopolymerizable plant derived protein derivatives such zein were recognized in the art as alternatives for photopolymerizable cellulose derivatives such as those used in Nicoll. The prior art recognized photopolymerizable plant derived protein derivatives such zein acrylates and photopolymerizable cellulose acrylate derivatives as equivalent biocompatible biomaterials useful for polymerizing into implantable hydrogel materials.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify biomaterials taught by Nicoll by incorporating a plant protein derivative such as zein acrylates with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution, or combination, of art recognized materials useful for the same purpose to achieve predictable results. See MPEP 2144.06. The skilled artisan would have had a reasonable expectation of success since the skilled artisan understood from Hubbell that acrylated plant proteins such as zein may be used to form biocompatible hydrogels in the same way as acrylated cellulose derivatives like those of Nicoll.
Accordingly, the subject matter of claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13, 14, and 15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shoseyov, US 20210138113 A1 and Hubbell, US 20040138329 A1.
The teachings of Shoseyov enumerated above teach a biomaterial composition according to claim 1, wherein the biomaterial includes a plant-based protein, but does not expressly teach the composition comprising the particular plant-based proteins according to claim 14.
However, Hubbell teaches plant proteins like zein could be acrylated in the same way as collagen and gelatin to provide photopolymerizable crosslinked hydrogel materials use
Hubbell teaches plant-based proteins like zein may be acrylated in the same way as collagen and gelatin and used as a photopolymerizable macromer (Hubbell, e.g., 0108-0109) like acrylated collagen and gelatin. The zein macromers are useful in biomaterials for encapsulation of cells and tissue (Hubbell, e.g., 0024-0027), and wherein the material is non-toxic and biocompatible for implantation (Hubbell, e.g., 0006) as a hydrogel (Hubbell, e.g., 0115, Thus, photopolymerizable plant derived protein derivatives such zein were recognized in the art as alternatives for photopolymerizable protein derivatives like those used in Shoseyov. The prior art recognized photopolymerizable plant derived protein derivatives such zein acrylates and photopolymerizable collagen and gelatin acrylate derivatives as equivalent biocompatible biomaterials useful for polymerizing into implantable hydrogel materials.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify biomaterials taught by Shoseyov by incorporating a plant protein derivative such as zein acrylates with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution, or combination, of art recognized materials useful for the same purpose to achieve predictable results. See MPEP 2144.06. The skilled artisan would have had a reasonable expectation of success since the skilled artisan understood from Hubbell that acrylated plant proteins such as zein may be used to form biocompatible hydrogels in the same way as acrylated collagen and gelatin derivatives like those of Shoseyov.
Accordingly, the subject matter of claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13 and 14-15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-2, and 4-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-15, 17, 21, 23, 27, and 42 of US 18285602 in view of Shoseyov, US 20210138113 A1, Attar, 20200237957 A1, and Hubbell, US 20040138329 A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims are directed to a foam biomaterial comprising: a biomaterial ink having an interconnected pore structure, wherein the foam biomaterial has a porosity from about 10% to about 90%. The foam comprising at least one of: a polymer, a protein, or a combination thereof (claim 3). The material further comprises an additive in an amount of from 0 to 90 % (claim 4-5). The foam biomaterial is crosslinkable through photocrosslinking (claim 6).
The reference claims do not expressly teach a photoinitiator. The reference claims do not expressly teach a plant-based biomaterial. The reference claims do not expressly teach the material seeded with cells.
However, Shoseyov teaches compositions comprising a photoinitiator and a plant-based protein which is functionalized with reactive groups that are crosslinkable via free radical polymerization, e.g., acrylated gelatin as enumerated above. Shoseyov teaches plant derived proteins such as collagen are beneficial since they reduce the risk of infection relative to animal derived proteins, have a more consistent structure, and retain a greater number of cell binding domains (Shoseyov, e.g., 18-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the foam of the reference claims using a plant-based protein with a reasonable expectation of success. Since the reference claims teach the biomaterial comprising a protein, the skilled artisan would have selected a plant-based protein because Shoseyov teaches plant derived proteins such as collagen improve biomaterials since they reduce the risk of infection relative to animal derived proteins, have a more consistent structure, and retain a greater number of cell binding domains. The skilled artisan would have seen this modification as the use of a known technique to improve similar biomaterials in the same way. The skilled artisan would have had a reasonable expectation of success since the reference claims teach the biomaterial should support cellular infiltration and Shoseyov teaches plant based proteins such as collagen offer less risk of cell death or infection due to infectious agent relative to animal derived proteins.
Shoseyov further teaches crosslinking may be facilitated with a photoinitiator which enables the biomaterial to be solidified in the body using only light (Shoseyov, e.g., 0225).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to additionally include a photoinitiator to facilitate crosslinking of the free radical groups in the same way suggested by Shoseyov. The skilled artisan would have been motivated to include a photoinitiator because this enables crosslinking and solidification of the material at the desired site of treatment, e.g., after injection, which increases the flexibility of how the material can be used.
Attar teaches cells may be seeded before or after crosslinking (Attar, e.g., 0326-0327). This supports tissue formation and mimics the native extracellular matrix (Attar, e.g., 0152-0156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the biomaterial foam taught by the reference claims and Shoseyov by seeding the materials with cells to improve the biomaterial in the same way suggested by Attar with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to support tissue formation and further mimic the extracellular matrix of the tissue site in which the material is placed in the same way suggested by Attar. The skilled artisan would have had a reasonable expectation of success because Attar teaches this modification for porous scaffolds.
The reference claims and Shoseyov do not expressly teach wherein the protein comprises plant albumin, globulin, glutelin, legumin, vicilin, gliadin, glutenin, zein, cupin and/or transferrin.
However, Hubbell teaches acrylated zein may be used as a photocrosslinkable macromer in the same way as acrylated collagen/gelatin for the structural make up of a biomaterial which may be polymerized in the presence of cells. See citations above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify biomaterials taught by the reference claims, Shoseyov, and Attar by incorporating a plant protein derivative such as zein acrylates with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution, or combination, of art recognized materials useful for the same purpose to achieve predictable results. See MPEP 2144.06. The skilled artisan would have had a reasonable expectation of success since the skilled artisan understood from Hubbell that acrylated plant proteins such as zein may be used to form biocompatible hydrogels in the same way as acrylated collagen and gelatin derivatives like those of Shoseyov for polymerization in the presence of cells.
Accordingly, the subject matter of claims 1-2, and 4-15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
Prosecution Insights