DETAILED ACTION
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 .
Election/Restrictions
Claims 19-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/22/2025.
Applicant’s election without traverse of Group I, claims 1, 2, 4-13 in the reply filed on 9/22/2025 is acknowledged.
Following species elections were made in the response filed 9/22/2025: Claim 2: polysaccharides, Claim 8: muscle cells, Claim 10: stabilizer, Claim 11: poly-e-lysine, Claim 12: carboxyl groups.
Claims status
Claims 3, 14-18 is/are cancelled and claims 24-28 is/are newly added. Claims 1-2, 4-13, 19-28 is/are currently pending with claims 19-28 is/are withdrawn. Claims 1-2, 4-13 is/are under examination.
Information Disclosure Statement
The listing of references in the specification, such as on pages 2-4, is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 1, line 23. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim is missing the units of measure after the number ‘50’ in line 3. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Immunoglobulin is misspelled in line 2 as ‘inmuglobulin’. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 5, 6, 11 and 12 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, 4, 5, 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For example, in claim 2 it is unclear if the claim requires the preferred narrower list of alternative species of alginate and/or chitosan to be merely optional or further limiting the broader list of alternative species recited in the same claim. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad limitation such as polysaccharide, and the claim also recites “preferably […] chitosan and/or alginate” which are the narrower statement of the limitation. Similarly, claim 4 recites the broad range of 1 um to 10000 um, and the claim also recites “preferably from 50 to 1000 um, more preferably from 100 um to 1000 um, or even more preferably from 100 um to 500 um” which are the narrower statement of the range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 recites “wherein is sterilized alternatively by”. Claim 5 depends from claim 1 which is a product claim requiring the product to be ‘sterilizable’ but does not require the product to be sterilized. In other words, the product of claim 1 is not limited to only scaffolds that are already sterilized. It is unclear what the limitation of claim 5 is an alternative to. Furthermore, alternative limitation that do not further limit the elements of the claim 1 can be interpreted as broadening claim 1 (see 112d rejection below).
Furthermore, in contrast to claim 1, claim 5 appears to recite an active process step (sterilize by) which in the context of a product claim could be interpreted as a “product-by-process” limitation. According to MPEP 2113, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps”. However, since claim 1 does not recite a sterilized scaffold or a ‘product-by-process’ limitation, it appears the ‘alternative’ “product-by-process” limitation of claim 5 may lack antecedence. Additionally, it is unclear what structure is provided to the claimed product by the process step of sterilization by the specifically recited techniques, if any. At least sterilization techniques such as non-ionizing radiations such UV-sterilization and ionizing gamma irradiation are expected to not alter structure of some scaffolds (see Abstract in Fischbach et. al., Surface Science, 491 (2001) 333-345 and; Ease of Sterilization in Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022). For the purpose of compact prosecution, the claim(s) 5 is/are interpreted as “wherein the scaffold is sterilizable alternatively by”.
Claim 6 is/are rejected due their dependence on claim 5 because they do not clarify the 112b issues noted with claim 5.
Claim 12 recites “amine groups, hydroxyl groups, carbonyl, groups, aldehyde groups, carboxylate group, carbonate group, carboxyl groups, carboxamide groups, imine groups, imide groups, thiol groups, inorganic ions and any combinations thereof” as cross-linker agents. Although these groups are present at the end of molecules to be cross-linked by a cross-linker agents, these groups are not known as cross-linker agents in the art. Abka-khajouei et al (Mar. Drugs 2022, 20, 364) teaches that “Alginates contain many free hydroxyl (-OH) and carboxyl (-COOH) groups that enable them to form intramolecular hydrogen bonds” while agents such as calcium ions cross-link the alginate units i.e. Ca2+ is the cross-linker agent and not the carboxyl groups (page 6, para 2; Figure 5). For the purpose of compact prosecution, the claim(s) 12 is/are interpreted as “wherein the cross-linker agent cross-links any one of the following groups: [..]”.
Claim Rejections - 35 USC § 112(d)
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 5 and 6 are 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 5 recites “wherein is sterilized alternatively by a physical or a chemical process, preferably a physical sterilization process” and Claim 6, that depends from claim 5, recites “wherein, the physical sterilization is selected from the list consisting of: dry heat, tyndallisation, and ionizing or non-ionizing radiation.” The claims suffer from indefiniteness issues, as detailed above. Additionally, when interpreting the claim 5 as “wherein the scaffold is sterilizable alternatively by”, the claim may embrace products not embraced by claim 1. In other words, alternate sterilization techniques of claim 5 and 6 may encompass scaffolds that are sterilizable by the ‘alternate’ techniques of claim 5 and not sterilizable by hot steam of claim 1. Thus, in reciting alternatives to claim 1, claims 5 and 6 fail to further limit claim 1.
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.
Improper Markush rejection
Claim 2 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
The Markush grouping of 2 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The alternatives recited are not all members of the same physical or chemical class because recited alternatives embrace distinct classes of molecules, such as polynucleotides (i.e. DNA, RNA etc.), polysaccharides (i.e. sugar chains etc.), glycosaminoglycan (i.e. polysaccharides but with amino groups), polyesters (polymers with ester linkages). These alternatives do not belong to an art-recognized class because the knowledge in the art does not teach that each of the distinct categories of molecules listed would function as 3-D tissue engineering scaffolds, especially wherein the scaffolds are required to have properties such as edibility and sterilizability by hot steam. Furthermore, the specification explicitly teaches that alternatives recited are not functionally equivalent. The specification explicitly teaches that “In the present invention is highly recommended to avoid the use of natural polymer selected from the list consisting of collagen, albumin (all types and forms), caseins, hyaluronic acid, fibrin, fibronectin and elastin, among others as they are not suitable for hot steam sterilization process.” (page 7; emphasis added)
The alternatives recited do not each comprise a structural feature that is substantial such that a common use flows from this substantial structural feature. The alternatives are structurally highly variable encompassing molecules such as at least DNA, heparin, alginate, chitin that do not share a structural feature and do not share a common use, especially within the context of the instant claims.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim(s) 1-2, 4-6, 9-10, 12, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (Theranostics 2015, Vol. 5, Issue 6) as evidenced by Enrione et al (Materials 2017, 10, 1404; IDS 12/8/2022), Jiang et al (Polymers 2019, 11, 1973, Fischbach et. al., Surface Science, 491 (2001) 333-345 and Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022).
Regarding claims 1-2, 13, Chen discloses a three-dimensional scaffold comprising alginate, a natural biocompatible polymer, wherein the scaffold are in the form of hydrogels (alginate is a polysaccharide as required by claim 2; hydrogel as required by claim 13; Title, Abstract, Ca-Alginate scaffold fabrication and preparation; page 644, col.2, para 2; page 653, col. 1, last para and col.2, lines 13-18).
The properties recited in the preamble of claim 1 (i.e. edible, sterilizable by hot steam, macroporous, for the intended use of tissue engineering) are inherent to Chen’s scaffold that comprises the natural polymer of alginate. MPEP 2112.01(II) guides that "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
To this end, Chen evidences that their scaffold are macroporous (large pore size upto 360um is disclosed in Characterization of Ca-Alginate scaffolds). Enrione evidences that alginate comprising scaffolds are edible, and both Chen and Enrione evidence that alginate scaffold are intended for use in tissue engineering purposes including for cultured meat applications (Enriones’s Abstract and Chen’s Abstract). The thermal stability of alginate comprising scaffolds is evidenced by Jiang that shows that alginate sponges do not decompose till 150°C (page 6, para 2; Figure 5).
Regarding claim 4, Chen discloses a pore size of 0.003-360um wherein pores are interconnected and hierarchical (Characterization of Ca-Alginate scaffolds, Figure 2 shows interconnected pores of various sizes, Table 1 for scaffold porosity measures). Chen used the freeze-drying technique to generate their scaffolds (Ca-Alginate scaffold fabrication and preparation) which inherently result in a highly porous hierarchical structure due to the sublimation of frozen water out of the pores that the water molecules created and occupied (see description 3D Freeze-Dried Scaffolds in Elkasabgy as evidence).
Regarding claims 5 and 6, in view of 112b issue noted above, the property of ‘sterilizable by’ a specific technique are inherent to Chen’s scaffold that teaches a scaffold with the claimed structure. Additionally, Chen sterilizes their sponge by chemical means of 75% ethanol i.e. “sterilizable by chemical process” (Ca-Alginate scaffold fabrication and preparation) and sterilization by non-ionizing radiation such as UV are generally considered not to alter the structure and are easily optimized to not alter structure, as evidenced by Fishbach (Abstract).
Regarding claims 9 and 10, Chen discloses use of calcium chloride as an additive that stabilizes the scaffold by cross-linking the alginate gel (Ca-Alginate scaffold fabrication and preparation).
Regarding claim 12, in view of 112b issue noted above, Chen discloses use of calcium as a cross-linking agent that cross links alginate molecules at carboxyl groups (Ca-Alginate scaffold fabrication and preparation).
Therefore, Chen anticipates the claims.
Claim(s) 1-2, 4-7, 9-10, 12, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cai et al (Science and Technology of Advanced Materials, 2017 VOL. 18, NO . 1, 987–996) as evidenced by Muzzarelli et al (Mar. Drugs 2015, 13, 7314–7338) and Zo et al (Gels 2025, 11, 610.) and Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022).
Regarding claims 1-2, 13, Cai discloses a three-dimensional scaffold comprising chitosan, a natural biocompatible polymer, which are hydrogels owing to their gel nature in presence of aqueous medium such as during cell culture (chitosan is a polysaccharide as required by claim 2; Title, Abstract, 2.1. Fabrication of porous chitosan scaffolds, 2.5. Cell seeding on porous chitosan scaffold with growth factors; Figure 1).
The properties recited in the preamble of claim 1 (i.e. edible, sterilizable by hot steam, macroporous, for the intended use of tissue engineering) are inherent to Cai’s scaffold that comprises the natural polymer of chitosan. MPEP 2112.01(II) guides that "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
To this end, Cai evidences that their scaffold are macroporous (large pore size upto 180um is disclosed in Figure 1 and 2). Muzarelli evidences that chitosan is sterilizable and intended for use in tissue engineering (1.2. Characteristic Properties of Chitosans, Abstract). Zo evidences that chitosan scaffolds are edible (Abstract).
Regarding claim 4, Cai discloses a pore size of 40-180um wherein pores are interconnected and hierarchical (Figure 1 and 2). Cai used the freeze-drying technique to generate their scaffolds (2.1. Fabrication of porous chitosan scaffolds) which inherently result in a highly porous hierarchical structure due to the sublimation of frozen water out of the pores that the water molecules created and occupied (see description 3D Freeze-Dried Scaffolds in Elkasabgy as evidence).
Regarding claims 5 and 6, in view of 112b issue noted above, the property of ‘sterilizable by’ a specific technique are inherent to Cai’s scaffold that teaches a scaffold with the claimed structure. Additionally, Cai sterilizes their sponge by physical means of non-ionizing UV-radiation (2.5. Cell seeding on porous chitosan scaffold with growth factors).
Regarding claim 7, Cai discloses non-human cells distributed throughout their scaffold (2.4. Cell tolerance to growth factors, 2.5. Cell seeding on porous chitosan scaffold with growth factors).
Regarding claims 9 and 10, Cai discloses use of genipin as an additive that stabilizes the scaffold by cross-linking the chitosan gel (2.1. Fabrication of porous chitosan scaffolds).
Regarding claim 12, in view of 112b issue noted above, Cai discloses use of genipin as a cross-linking agent that cross links chitosan molecules at amine groups, as evidenced by Muzarelli (see Figure 1 in Muzarelli; 2.1. Fabrication of porous chitosan scaffolds in Cai).
Therefore, Cai anticipates the claims.
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, 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.
Claim(s) 7, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Theranostics 2015, Vol. 5, Issue 6) as evidenced by Enrione et al (Materials 2017, 10, 1404; IDS 12/8/2022), Jiang et al (Polymers 2019, 11, 1973, Fischbach et. al., Surface Science, 491 (2001) 333-345 and Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022). as applied to claim 1 above, and further in view of Enrione et al (Materials 2017, 10, 1404; IDS 12/8/2022).
The teachings of Chen as applied to claim 1 above are pertinent to the instant rejection.
Regarding claims 7 and 8, Chen discloses human osteoblasts seeding in their scaffold (Cell seeding method).
Chen does not teach a non-human muscle cell seeding, as required by claim 7, 8.
Enrione teaches 3-D scaffolds seeded with non-human muscle cells (2.6. Myoblast Cell Culture, 2.7. Evaluation of Scaffold Biocompatibility, 3.3. Biocompatibility of the Scaffolds with Myoblasts). Enrione also uses an alginate based scaffold, however includes fish gelatin in their scaffold (2.1. Experimental Strategy). Enrione teaches the use of non-human muscle cells to allow for manufacture of edible cultured meat product using edible 3D scaffolds (Abstract).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the human osteoblasts cells of Chen with non-human muscle cells of Enrione to generate an edible 3D alginate scaffold with muscle cells. An artisan would be motivated to make such a substitution because it would allow for generation of cultured meat without any need of gelatin such as taught by Enrione. This would be appealing to individuals who are opposed to consuming animal products, such as vegans. An ordinary artisan would reasonably expect to substitute Chen’s human osteoblasts with Enrione’s non-human muscle cells because both Chen and Enrione use alginate based scaffolds.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (Theranostics 2015, Vol. 5, Issue 6) as evidenced by Enrione et al (Materials 2017, 10, 1404; IDS 12/8/2022), Jiang et al (Polymers 2019, 11, 1973, Fischbach et. al., Surface Science, 491 (2001) 333-345 and Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022). as applied to claims 1 and 9 above, and further in view of Venkatesh et al (Antimicrob Agents Chemother 61:e00469-17. 2017).
The teachings of Chen as applied to claim 1 and 9 above are pertinent to the instant rejection.
Regarding claim 11, Chen does not teach poly-e-lysine as a bioactive additive.
Venkatesh teaches that poly-e-lysine is an excellent anti-microbial agent that is highly bactericidal at low concentrations and requires very high concentration to show cytotoxicity against mammalian cells (Table 1).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include poly-e-lysine in the scaffold of Chen or substitute Chen’s antibiotic with poly-e-lysine to prevent microbial growth on the scaffold. An ordinary artisan would be motivated to include poly-e-lysine in Chen’s scaffold because it would allow the cells seeded on Chen’s scaffold to remain contamination free. An ordinary artisan would reasonably expect to include poly-e-lysine in Chen’s scaffold by either including or substituting it in place of Chen’s antibiotic. Considering the extremely low cytotoxicity of poly-e-lysine to mammalian cells, an ordinary artisan expects inclusion of poly-e-lysine to not adversely affect Chen’s cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al (Science and Technology of Advanced Materials, 2017 VOL. 18, NO . 1, 987–996) as evidenced by Muzzarelli et al (Mar. Drugs 2015, 13, 7314–7338) and Zo et al (Gels 2025, 11, 610.) and Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022) as applied to claims 1 and 7 above, and further in view of Enrione et al (Materials 2017, 10, 1404; IDS 12/8/2022).
The teachings of Cai as applied to claims 1 and 7 above are pertinent to the instant rejection.
Regarding claims 8, Cai discloses non-human fibroblasts and/or endothelial cells seeding in their scaffold (2.5. Cell seeding on porous chitosan scaffold with growth factors).
Cai does not teach non-human muscle cells.
Enrione teaches 3-D scaffolds seeded with non-human muscle cells (2.6. Myoblast Cell Culture, 2.7. Evaluation of Scaffold Biocompatibility, 3.3. Biocompatibility of the Scaffolds with Myoblasts). Enrione teaches the use of non-human muscle cells to allow for manufacture of edible cultured meat product using edible 3D scaffolds (Abstract).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the non-human fibroblasts and/or endothelial cells of Cai with non-human muscle cells of Enrione to generate an edible 3D chitosan scaffold with muscle cells. An artisan would be motivated to make such a substitution because it would allow for generation of cultured meat with a different 3D scaffold such as chitosan thus providing a variety in the cultured food product marketplace. An ordinary artisan would reasonably expect to substitute Cai’s non-human fibroblasts and/or endothelial cells with Enrione’s non-human muscle cells because chitosan-based scaffolds have been used for seeding a variety of cells in a variety of contexts and are thus compatible with several cell types. Muzarelli evidences that chitosan based scaffolds have been used for a variety of cells such as adipose stem cells, rabbit chondrocytes, bovine chondrocytes, fibroblasts, osteoblasts and ostroclasts (3. Stem Cells in Regenerative Medicine, 5. Genipin-Crosslinked Collagen/Gelatin for the Regeneration of the Cartilage, 5.1. Fibrin, Poly‐L‐Lysine, Heparin, Hyaluronan, 6. Bone Regeneration).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al (Science and Technology of Advanced Materials, 2017 VOL. 18, NO . 1, 987–996) as evidenced by Muzzarelli et al (Mar. Drugs 2015, 13, 7314–7338) and Zo et al (Gels 2025, 11, 610.) and Elkasabgy et al, AAPS PharmSciTech (2019) 20: 256; IDS 12/8/2022) as applied to claims 1 and 9 above, and further in view of Venkatesh et al (Antimicrob Agents Chemother 61:e00469-17. 2017).
The teachings of Cai as applied to claim 1 and 9 above are pertinent to the instant rejection.
Regarding claim 11, Cai does not teach poly-e-lysine as a bioactive additive.
Venkatesh teaches that poly-e-lysine is an excellent anti-microbial agent that is highly bactericidal at low concentrations and requires very high concentration to show cytotoxicity against mammalian cells (Table 1).
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include poly-e-lysine in the scaffold of Cai or substitute Cai’s antibiotic with poly-e-lysine to prevent microbial growth on the scaffold. An ordinary artisan would be motivated to include poly-e-lysine in Cai’s scaffold because it would allow the cells seeded on Cai’s scaffold to remain contamination free. An ordinary artisan would reasonably expect to include poly-e-lysine in Cai’s scaffold by either including or substituting it in place of Cai’s antibiotic. Considering the extremely low cytotoxicity of poly-e-lysine to mammalian cells, an ordinary artisan expects inclusion of poly-e-lysine to not adversely affect Cai’s cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 2, 5-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19, 1, 3, 14-17, 20-22 of copending Application No. 18/001,110 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 19 in `110 is directed to a 3D scaffold that is edible, macroporous, sterilizable by hot steam, for tissue engineering comprising a biocompatible polymer. Although this claim recites that the product is made by the process of claim 1 i.e. a product-by-process limitation, the structure of the claimed product of claim 19 is not patentably distinct from the product of instant claim 1 with the only distinct being that the instant claim 1 requires the polymer be of natural-origin. However, use of natural biocompatible polymer in an edible scaffold is obviously since claim 3 of `110 teaches several natural polymers. The listed polymers are same as instant claim 2. Furthermore, since the sterilization properties are inherent to the scaffold material, claim 19 of `110 in view of claim 3 of `110 render instant claims 5 and 6 prima facie obvious.
It should also be noted that the method of claims 1 and 3 of `110 disclose that the product made is sterilizable by hot steam in step (e) and that the product made is macroporous, 3D and for tissue engineering in the preamble and comprises a natural polymer in step (a); wherein the natural polymer is inherently edible as listed in claim 3. Therefore, the method of claims 1 and 3 of `110 disclose the instantly claimed product of claim 1 and 2.
Claims 20-22 of `110 teach scaffold of claim 19 of `110 to comprise muscle cells from non-human sources. This renders obvious instant claims 7, 8.
Claims 14-17 of `110 teach scaffolds further comprising the agents recited in instant claims 9-12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/MATASHA DHAR/Examiner, Art Unit 1632