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.
Status of the Claims
The response and amendment filed 08/13/2026 is acknowledged.
Claims 1-13 and 15-20 are pending.
Claims 16-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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Claim 3 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 4-13, and 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 Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 6 and 14-15 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claim 8 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claim 11 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claim 13 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 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 4, 5, 7, 8, 10, 12, and 13 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Nicoll, US 20110182957 A has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13 and 15 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Shoseyov, US 20210138113 A1 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 4, 5, 7, 8, and 9-13 under 35 U.S.C. 103 as being unpatentable over Nicoll, US 20110182957 A and Attar, 20200237957 A1 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 15 under 35 U.S.C. 103 as being unpatentable over Shoseyov, US 20210138113 A1 and Attar, 20200237957 A1 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13, 14, and 15 under 35 U.S.C. 103 as being unpatentable over Nicoll, US 20110182957 A and Hubbell, US 20040138329 A1 has been withdrawn because of Applicant’s amendment.
The rejection of claims 1-2, 4, 5, 6, 7, 8, 10, 12, 13 and 14-15 under 35 U.S.C. 103 as being unpatentable over Shoseyov, US 20210138113 A1 and Hubbell, US 20040138329 A1 has been withdrawn because of Applicant’s amendment.
Response to Arguments
Applicant’s arguments with respect to prior art rejections of claim(s) 1-13 and 15 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.
Applicant’s arguments regarding the rejection of claims 7, 9, 10, 11, and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been considered but are unpersuasive.
Applicant argues that Claim 7 is now amended to state that biomaterial composition further comprises cells to form a bioink prior to undergoing free radical polymerization thus rendering this rejection moot. The Applicants do not believe that the phrase "prior to undergoing free radical polymerization" should be deleted from the claim because it is the one way to state that the uncured biomaterial composition contains cells. Applicant argues terms that are used to describe a process or method can also be used to describe a structure.
This argument is unpersuasive. To the extent that the process step, undergoing free radical polymerization, describes a structure, claim 1 requires the composition is uncrosslinked. The structure implied by the process step would place the scope of the subject matter outside the scope of claim 1 because a composition which is undergoing, or has undergone, free radical polymerization would then be crosslinked. Claim 4 explicitly states free radical polymerization induces crosslinking of the uncrosslinked plant-based material. For this reason, forming a bioink and undergoing free radical polymerization is either, i) an improper process step in a product claim – which would raise an issue under 112(d) because it changes the structure of the plant-based biomaterial functionalized with reactive groups from uncrosslinked to crosslinked – or ii) it is an intended use recitation.
Under the interpretation that the limitation is an intended use, the presence or absence of cells is unclear. Adding cells to the composition of claim 1 prior to crosslinking is an intended structural feature of the formulation which is contingent on free radical polymerization. Since the composition is required to be uncrosslinked by claim 1, and the inclusion of cells is dependent on the act of polymerization which results in crosslinking, the presence of cells is ambiguous. The claim is silent as to whether cells must be present while the composition is in an uncrosslinked state. The scope of the claim depends on an act which may or may not happen. Thus, the skilled artisan cannot determine if cells are required. In other words, the presence of cells is contingent upon future conditions - form a bioink and undergoing free radical polymerization - but is silent to the presence of cells when the composition is not a bioink and not undergoing free radical polymerization, i.e., is uncrosslinked as required by claim 1. Therefore, the skilled artisan cannot determine if cells are required to infringe claim 7, and if so, when cells are required to be present in the uncrosslinked composition of claim 1.
The court cases cited by Applicant do not appear to be relevant here because the fact pattern in each of the cited cases does not include a contingent limitation and the structure implied by the process steps in the cited cases does not raise an issue under 112(d).
Applicant’s argument that “prior to undergoing free radical polymerization” is the one way to state that the uncured biomaterial composition contains cells is unpersuasive because the language makes the presence of cells contingent upon free radical polymerization. Deleting “prior to undergoing free radical polymerization” is another way to clearly require that the uncured biomaterial of claim 1 further comprises cells so that the skilled artisan understands how to avoid infringement.
Applicant has argued Claim 9 is directed to "the biomaterial composition being in the form of a liquid foam prior to the free radical polymerization." Applicant argues that Claim 9 only states a form of the biomaterial composition (i.e., it is in the form of a foam) at a point in time (prior to being cured by free radical polymerization). This is not a product limitation because there are no process steps being performed. Applicant argues that the Examiner appears to have made an inadvertent error in assuming that there is a process step in the claim. Applicant argues that it further cannot be a product claim reciting an intended use, especially if the Examiner has previously concluded that it includes a process limitation. The Applicants are confused by these statements because they appear to contradict each other.
This argument is unpersuasive. As stated by Applicant, claim 9 requires the form of a liquid foam at a point in time prior to being cured by free radical polymerization. The skilled artisan cannot determine the point in time the foam form is required because the point in time is contingent upon the step of free radical polymerization.
It is unclear what Applicant is arguing is not a product limitation.
Free radical polymerization is a process step implied by claim 9, and the phrase makes the form of a foam contingent on the act of free radical polymerization.
Applicant’s argument that it further cannot be a product claim reciting an intended use is unclear. The skilled artisan would understand Claim 9 to be a product claim which recites a limitation that may be construed either as recitation of intended use, i.e., free radical polymerization, or as an implied process step.
As stated in the rejection, the claim was interpreted as reciting an intended use on the merits.
Like claim 7 above, the presence of a liquid foam is contingent upon a future condition – prior to the free radical polymerization - but makes no limitation on the point in time the liquid foam form is required, e.g., the required form when the composition is not undergoing free radical polymerization. In other words, the skilled artisan cannot determine the point in time the liquid foam form is required to avoid infringement. An uncrosslinked composition per claim 1 may be in several forms, e.g., powder, and used in several ways, e.g., placed in a bottle on a shelf for storage, poured into a mold, combined with a liquid, etc. The composition of claim 1 may be in the form of a liquid foam without any intent of immediate free radical polymerization. Since the limitation is contingent on an intended use, the skilled artisan cannot determine if the composition is required to be in form of a liquid foam to infringe claim 9, and if a foam is required, what point in time the form of a foam is required to be present, e.g., only prior to polymerization or some other time.
Applicant has argued that Claim 11 as presently amended is directed to a liquid foam that comprises cells to form a bioink. Applicant argues this is a composition claim (a liquid foam that contains cells) that includes no process limitations and does not include an intended use.
This argument is not persuasive for similar reasons explained under claims 7 and 9 above. The liquid foam form and cells in claim 11 are contingent on the free radical polymerization limitation from claim 9. The skilled artisan cannot determine at what point in time claim 11 requires a liquid foam that contains cells to understand how to avoid infringement.
Applicant argues that Claim 10 is directed to a biomaterial composition being in the form of an unfoamed liquid prior to the free radical polymerization. Applicant argues that Claim 10, like Claim 9, is directed to the state of matter - i.e., it specifies that the biomaterial composition is in an unfoamed state at a point in time (prior to free radical polymerization). Applicant argues that there is no process limitation in the claim and there is no statement of intended use.
This argument is not persuasive for similar reasons explained under claims 7 and 9 above. The unfoamed liquid form in claim 10 is contingent on the act of free radical polymerization. An uncrosslinked composition per claim 1 may be in several forms, e.g., powder, and used in several ways, e.g., placed in a bottle on a shelf for storage, poured into a mold, combined with a liquid, etc. The composition of claim 1 may be unfoamed without any intent of immediate free radical polymerization. The skilled artisan cannot determine at what point in time claim 10 requires an unfoamed liquid form to understand how to avoid infringement.
Applicant has argued claim 13 is presently amended to state that the additive is present in an amount of "up to, 90 wt%. Applicant has argued that since Claim 12 states that an additive is present in the biomaterial composition, it follows that Claim 13 (which depends from Claim 12) must require that more than zero percent of the additive is present in the biomaterial composition.
This amendment overcomes the previous rejection under 112(d). However, there is no antecedent basis for “the construct” in claim 13. Claims 1 and 12 refer to an uncrosslinked composition rather than a construct. It is not clear what “the construct” was intended to refer to. The skilled artisan cannot determine “a total weight of the construct” 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.
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 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 further comprises 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 a contingent limitation, i.e., prior to undergoing free radical polymerization. The skilled artisan cannot determine whether free radical polymerization is required for the cells to be present. 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 by deleting “prior to undergoing free radical polymerization.”
Claim 7 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 a contingent limitation, 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 a contingent limitation, 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.
The presence of the foam form and cells are contingent limitations, i.e., prior to undergoing free radical polymerization (from claim 9). 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 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 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, 4-13 and 15 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Jiang, US 20210171773 as evidenced by Shen, Food Research International, 157, 2022.
Jiang teaches a composition comprising an uncrosslinked methacrylated soy protein isolate which is a plant-based protein. Methacrylated Soy protein isolate (Jiang, e.g., example 1 and claim 3) comprises at least globulin (Shen, e.g., pg. 6, 3.4.1 Globulin and pg. 8, conclusion) and 2s albumin (Shen, e.g., pg. 8 conclusion).
Applicable to claim 2: The composition further comprises a photoinitiator (Jiang, e.g., claim 1 and claim 7).
Applicable to claims 4-5: the material is capable of being used according to claims 4-5.
Applicable to claim 6: Jiang teaches the protein is present in the composition in an amount of from about 40 to about 80 wt% which is entirely within the claimed range.
Applicable to claims 7-8: Claims 7-8 refer to an intended use of the composition of claim 1. Just as Jiang’s methacrylated SPI composition is capable of being poured into a Petri dish prior to free radical polymerization (Jiang, e.g., 0074), Jiang’s composition is capable of being seeded with cells prior to undergoing free radical polymerization. The claimed composition reads on compositions which do not contain cells, and which are not intended for immediate free radical polymerization, e.g., compositions comprising the features of claim 1 which are stored for future polymerization, because the phrase - prior to free radical polymerization - makes the presence of cells a contingent limitation.
Applicable to claims 9-11: Claims 9-11 refer to an intended use of the composition of claim 1. Just as Jiang’s composition is capable of being poured into a Petri dish prior to polymerization (Jiang, e.g., 0074), Jiang’s composition is capable of being foamed and then seeded with cells prior to free radical polymerization. The claimed composition reads on compositions which are not foamed, which do not contain cells, and which are not intended for immediate free radical polymerization, e.g., compositions comprising the features of claim 1 which are stored for future polymerization, because the phrase - prior to free radical polymerization - makes the presence of a foam and cells contingent limitations.
Applicable to claim 12 and 13: Jiang teaches the composition further comprising additives, e.g., nanofibers, carbon nanotubes, (Jiang, e.g., claims 4 and 10). Lubricant is a mold release agent. These additives, e.g., nanocellulose, carbon nanotubes, may be present in an amount ranging from 1 to 30 wt% (Jiang, e.g., 0045). This range is entirely within the claimed range.
Applicable to claim 15: soy protein isolate comes from legumes, i.e., soybeans.
Jiang anticipates the subject matter of instant claims 1-2, 4-13 and 15 as evidenced by Kumar, Biocatalysis and Agricultural Biotechnology, 17, 2019
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, 4-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nicoll, US 20110182957 A in view of Hubbell, US 20040138329 A1, and Jahangirian, Biomolecules, 2019 as evidenced by Shen, Food Research International, 157, 2022.
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 does not expressly teach wherein the uncrosslinked plant-based biomaterial comprises a plant-based protein that includes globulin, glutelin, legumin, vicilin, gliadin, glutenin, cupin, ovalbumin, conalbumin, legumelin, avenin, 1S albumin, 2S albumin, crambin, kafirin, transferrin, or a combination thereof.
However, the teachings of Hubbell and Jahangirian cure this deficiency as evidenced by Shen.
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), e.g., as a hydrogel (Hubbell, e.g., 0115).
Jahangirian teaches plant protein alternatives to zein (Jahangirian, e.g., pp. 21/40-25/40, e.g., 4.2) including soy protein isolate containing 50-90% protein (Jahangirian, e.g., pp. 15/40-21/40, e.g., 4.1) and gluten containing glutenin (Jahangirian, e.g., pp. 25/40-26/40). Jahangirian teaches the composition seeded with cells to facilitate formation of new tissue (Jahangirian, e.g., pg. 1/40-2/40, introduction). Jahangirian teaches desirable aspects of plant proteins include formulation benefits, easy production and scale up, improved availability and processing capacity, improved safety, biodegradability, biocompatibility, and reduced antigenicity (Jahangirian, e.g., entire document, e.g., pg. 3/40, Fig. 2). Soy protein isolate was used in combination with cellulose for tissue engineering (Jahangirian, entire document, e.g., 16/40).
Soy protein isolate comprises globulin (Shen, e.g., pg. 6, 3.4.1 Globulin and pg. 8, conclusion) and 2s albumin (Shen, e.g., pg. 8 conclusion).
Based on Hubbell and Jahangirian as evidenced by Shen, the skilled artisan understood photopolymerizable plant derived protein derivatives such zein, globulin, glutenin (a glutelin), and 2s albumin were recognized in the art as alternatives for photopolymerizable cellulose derivatives such as those used in Nicoll. The skilled artisan also understood that soy protein isolate and wheat gluten were used in combination with cellulose (Jahangirian, e.g., pg. 10/40 and 12/40 and pg. 16/40) in the field of tissue engineering. The prior art recognized photopolymerizable plant derived protein derivatives such zein, globulin, glutenin (a glutelin), and/or 2s albumin 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 globulin, glutenin (a glutelin), and/or 2s albumin acrylate with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution, or combination, of art recognized photopolymerizable 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 may be used to form biocompatible scaffolds in the same way as acrylated cellulose derivatives like those of Nicoll, and since the skilled artisan understood from Jahangirian that plant proteins including globulins/2s albumin (soy protein isolate) and glutenin/gliadin were each used alone or in combination with cellulose in the context of tissue engineering.
Applicable to claim 6, Jahangirian teaches soy protein containing 50-90% protein which suggests the material containing at least 40% by weight plant protein by weight of the biomaterial composition.
Applicable to claims 9 and 11: to the extent that claim 9 requires a liquid foam: Jahangirian teaches the materials may be configured as a foam (Jahangirian, e.g., pg. 3/40, e.g., Fig. 2) to provide porous scaffolds which facilitate the development of tissues, organs and rigid tissues (Jahangirian, e.g., pg. 6/40). It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to formulate the uncrosslinked biomaterial suggested by Nicoll, Hubbell, and Jahangirian as a foam using known techniques with a reasonable expectation of success. The skilled artisan would have been motivated to formulate the uncrosslinked material as a liquid foam so that the material could be polymerized into a porous scaffold to facilitate the development of tissues, organs and rigid tissues in the same way reported by Jahangirian.
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.
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, 4-13 and 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, Hubbell, US 20040138329 A1 and Jahangirian, Biomolecules, 2019 as evidenced by Shen, Food Research International, 157, 2022.
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.
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).
Shoseyov does not expressly teach wherein the uncrosslinked plant-based biomaterial comprises a plant-based protein that includes globulin, glutelin, legumin, vicilin, gliadin, glutenin, cupin, ovalbumin, conalbumin, legumelin, avenin, 1S albumin, 2S albumin, crambin, kafirin, transferrin, or a combination thereof.
However, the teachings of Hubbell and Jahangirian enumerated above cure this deficiency as evidenced by Shen.
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 improve biomaterials since they reduce the risk of infection relative to animal derived proteins and have a more consistent structure. Hubbell and Jahangirian teach protein alternatives to gelatin including globulins/2s albumin (soy protein isolate) and glutenin/gliadin for tissue engineering as evidenced by Shen. 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 offer less risk of cell death or infection due to infectious agent relative to animal derived proteins and since Jahangirian reports the claimed plant proteins were known and used for tissue engineering before the effective filing date of the presently claimed invention.
Shoseyov further teaches crosslinking may be facilitated with a photoinitiator which enables the biomaterial to be solidified 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 which increases the flexibility of how the material can be used.
Jahangirian teaches the scaffold may be seeded with cells to facilitate formation of new tissue (Jahangirian, e.g., pg. 1/40-2/40, introduction).
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 a 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 Jahangirian with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to support tissue regeneration and further mimic the extracellular matrix of the tissue site in which the material is intended to be placed in the same way suggested by Jahangirian. The skilled artisan would have had a reasonable expectation of success because Jahangirian teaches this modification for porous scaffolds.
Accordingly, the subject matter of claims 1-2, and 4-13, 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.
Conclusion
No claim is allowed.
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.
Correspondence
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.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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