Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 4-7 and 18 are cancelled. Claims 21-26 are new. Claims 1-3, 8-17, and 19-26 are pending and under exam.
WITHDRAWN REJECTOINS
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, and 13-20 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The rejection is withdrawn following Applicant amendments to specify the substance of the biocompatiable substance.
Claims 2-8, 14 and 17-18 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.
Claim 2 recites: “The cell-supporting body according to claim 1, wherein the base material is a formed body of a biocompatible substance.” And it was not clear form the wording of the claim if the biocompatible substance of claim 2 is different from the biocompatible substance recited in claim 1.
The rejection is withdrawn following Applicant amendments to recite:
The cell-supporting body according to claim 1, wherein the base material includes a formed body and the biocompatible substance applied to a surface of the formed body
Claim Rejections - 35 USC § 102
Claims 1-4, 6, 9-11, 13, 15-18, 20 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (Materials (Basel). 2015 Mar 10; hereinafter "Wang;" See PTO-892) as evidenced by Makadia et al (Polymers 2011; hereinafter "Wang;" See PTO-892).
The rejection is withdrawn following Applicant amendments to indicate the material of the biocompatible substance.
Claims 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Galli et al (Biomed Mater. 2016 Feb 2; hereinafter "Galli;" See PTO-892) as evidenced by Yadav et al (Carbohydrate Polymer Technologies and Applications; Published 2024; hereinafter "Yadav;" See PTO-892).
The rejection is withdrawn following Applicant amendments to indicate the material of the biocompatible substance.
Claims 1, 4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rizwan et al (ACS Applied Bio Materials 2020; hereinafter "Rizwan;" See PTO-892) as evidenced by Chiellini et al (Progress in Polymer Science.; hereinafter "Chilleni;" See PTO-892).
The rejection is withdrawn following Applicant amendments to indicate the material of the biocompatible substance.
Claim Rejections - 35 USC § 103
Claims 12 was rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (Materials (Basel). 2015 Mar 10; hereinafter "Wang;" See PTO-892) in view of Murata et al (Sci Rep. 2018 Oct 4; hereinafter "Murata;" See PTO-892).
Claims 1, 8, 14 and 19 were rejected under 35 U.S.C. 103 as being unpatentable over Tsung et al (AAPS PharmSci; hereinafter "Tsung"; See PTO-892).
The rejections are withdrawn in view of the claim amendments. New rejections are set forth below.
MAINTAINED REJECTIONS
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.
Claim 8 and 14 remain rejected for requiring an introduction rate of gelatin particle. The rejection is maintained as the metes and bounds of this claim are still unclear. Claim 8 requires “The cell-supporting body according to claim 1, wherein the biocompatible substance is a material selected according to an introduction rate of the gelatin particle into a cell to be supported by the cell-supporting body.”
The claim does not require any specific introduction rate. Instead, it recites a mental or design step. It is not clear which rates of gelatin uptake by the cells are preferred.
NEW REJECTION NECESSITATED BY CLAIM AMENDMENTS
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-3, 8-10, 13-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang et al (Biomed Mater Res A. 2016 Apr; hereinafter "Hwang;" See PTO-892).
Regarding claim 1-3: Hwang disclosed “a porous poly(ε-caprolactone) (PCL)/gelatin composite electrospun scaffold with crater-like structures was developed.” (See Hwang Abstract). As such the PCL reads on the base material including a biocompatible substance.
Further, it is noted that Hwang disclosed that “[c]omposite electrospun [PCL/gelatin] scaffolds with and without craterlike structures were cut into disks with 0.5 cm diameters, briefly sterilized under UV light for 30 minutes, and then placed into 48-well plates.” The 48 well plates read on the formed body as required by claim 3.
Regarding claim 8, 14 and 19: Hwang disclosed that “[v]arious ratios of PCL/gelatin (concentration ratios: 100/0, 75/25, and 50/50) composite electrospun scaffolds with and without crater-like structures were characterized by their microstructures, surface chemistry, degradation, mechanical properties, and ability to facilitate cell growth and infiltration. The combination of PCL and gelatin endowed the scaffold with both structural stability of PCL and bioactivity of gelatin.” As such Hwang disclosed that the gelatin was able to interact with the cultured cells rather than merely attaching. As such, this reads on the claimed “introduction rate of the gelatin particle into a cell to be supported by the cell-supporting body” as recited in claim 8.
Regarding claims 9-10: Hwang disclosed that “[i]n this study, we demonstrated the feasibility of developing a porous, ECM-mimicking, PCL/gelatin composite electrospun scaffold with crater-like structures. It is hypothesized that porous crater-like structures and PCL/gelatin composite nanofiber networks create a 3D, ECM-mimicking microenvironment, which can greatly improve the efficacy of cell scaffolds for tissue regeneration.” (See Huang, p.3, last para). As such Hwang disclosed a 3D shape of the PCL/gelatin composite as required by the claim.
Further Huang expressly disclosed a 2D electrospun nanofibers for incorporation of sodium bicarbonate to create crater like structure. (See Hwang Fig. 1 and specifically 1B). As such the electrospun nanofiber of 1B is interpreted to read on the 2D shaped base material, anticipating claim 9.
Regarding claim 13 and 20: Hwang disclosed a method of generating the claimed cell supporting body: “in our study we combined a gas foaming and salt leaching strategy to generate pore spaces. During electrospinning, sodium bicarbonate particles were incorporated into the scaffold as the fibers deposited onto the collector. After the scaffold had formed, it was placed into a mildly acidic solution (citric acid). The citric acid reacted with the sodium bicarbonate to generate carbon dioxide (CO2) gas; this blowing gas expanded the scaffold to create crater-like structures. The crater-like structure has a loosely packed fiber network and its large pore areas are suitable for cell infiltration through the scaffold. These unique structures imitate the 3D aspect of an ECM structure, which allows more cell–cell and cell– ECM interactions through the scaffold than the conventional 2D electrospun fiber network.” (See Hwang, p. 3, 1st para).
Regarding claims 15-17: Hwang disclosed that “[c]omposite electrospun scaffolds with and without craterlike structures were cut into disks with 0.5 cm diameters, briefly sterilized under UV light for 30 minutes, and then placed into 48-well plates. About 50,000 hMSCs were seeded on each scaffold with 400 µL of media and cultured at normal culture conditions until 7 days; media was changed every 48 hours.” (See Hwang, p. 5, 5th para). As such, Hwang disclosed “[a] cell culturing method, comprising: preparing the cell-supporting body according to claim 1; and seeding a cell on the cell-supporting body” as required by the claim. The 48 well plates read on the claimed formed body.
Claims 25 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al (Sci Rep (2016); hereinafter "Huang;" See PTO-892).
Huang was directed to use of extracellular matrix, gelatin to incorporated into PVA solution to form electrospun PVA-gelatin nanofibers membrane. (See Huang Abstract). Additionally Figure 1 of Huang demonstrated a method of manufacture of the PVA-gelatin fibers to culture cells as required by claim 26. (See Huang p. 6, last para). Huang used collector plates used to collecting the electrospun PVA/gelatin scaffolds. (See Huang Fig. 1). They grew fibroblasts on the collector plates (See Huang p.7, 2nd para). As such the collector plates function as the cell culture plate in Huang. Further Huang used PVA-gelatin electrospun mesh as the biocompatible substance which comprises PVA. As such it would have been obvious for a person of ordinary skill in the art to use a cell culture plate instead of a collector plate to culture mammalian cells. A person of ordinary skill would have understood that such a substitution would yield predictable results.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al (Biomed Mater Res A. 2016 Apr; hereinafter "Hwang;" See PTO-892) as applied to claim 1 above further in view of Lee et al (Biomaterials. 2012 Oct; hereinafter "Lee;" See PTO-892).
Regarding claim 11: The teachings of Hwang are set forth above. Hwang did not teach use of an agent carried by gelatin. However, Lee disclosed “[h]eparin-conjugated electrospun poly(ε-caprolactone) (PCL)/gelatin scaffolds were developed to provide controlled release of platelet-derived growth factor-BB (PDGF-BB) and allow prolonged bioactivity of this molecule. A mixture of PCL and gelatin was electrospun into three different morphologies. Next, heparin molecules were conjugated to the reactive surface of the scaffolds.” As such Lee taught a PCL-gelatin mesh wherein gelatin particle carries a reagent or an agent. As such one of ordinary skill in the art would be motivated to use an agent bound to gelatin to incorporate an agent for delivery into the cells.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al (Biomed Mater Res A. 2016 Apr; hereinafter "Hwang;" See PTO-892) as applied to claim 1 above further in view of Murata et al (Sci Rep. 2018 Oct 4; hereinafter "Murata;" See PTO-892).
Regarding claim 12: The teachings of Hwang are set forth above. Hwang did not teach using molecular beacon as an agent. However, Murata taught preparation of cationized gelatin nanospheres (cGNS) incorporating a molecular beacon (MB), and visualize cellular apoptosis. (See Murata Abstract). Murata taught that the cationized gelatin and MB are electrostatically interacted to each other, and the negative charge of MB may be shielded by the positive charge of cationized gelatin. Murata indicated that cGNS is advantageous over PLGA nanoparticles because of the “simplicity of controlling degradability and the consequent controllability of nucleic acids release profile. The controlled release of nucleic acids regulated by the gelatin degradation have been applied extracellularly and intracellularly. Based on these reports, we strongly believe that cGNS enable the sustained release of MB, leading to the prolonged and controlled visualization of cellular biological functions.” (See Murata p. 7, para 2). As such one of ordinary skill in the art would be motivated to use a Molecular beacon incorporated in gelatin for visualization of biological functions in view of teachings of Murata.
Claim 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al (Biomed Mater Res A. 2016 Apr; hereinafter "Hwang;" See PTO-892) as applied to claim 1 above further in view of Nyugen et al (Biomaterials Science; Jun 27, 2020; Hereinafter “Nyugen;” See PTO-892).
Regarding claim 21 and 23: As indicated above Hwang taught “[c]omposite electrospun [PCL/gelatin] scaffolds with and without craterlike structures were cut into disks with 0.5 cm diameters, briefly sterilized under UV light for 30 minutes, and then placed into 48-well plates.” As such the structure Hwang taught is interpreted to read on the claimed base material. Hwang did not teach or suggest “a gelatin particle is immobilized in a region of the base material on which the biocompatible substance is attached.”
Nguyen was directed to methods of using and making “NFs were surface-engineered with multilayers of gelatin” (See Nguyen Abstract). Nguyen taught “PCL NFs (Gel/PCL NFs), PCL NFs were electrostatically coated with oppositely-charged gelatin through a LbL manner. Briefly, gelatin type A (GA, pI = 7.0–9.0) and type B (GB, pI = 4.7–5.2) were dissolved in phosphate buffer (pH 6.0) with gentle shaking at 37 °C. To absorb gelatin on the surface of the PCL NFs, 1 ml of gelatin solution (1, 10, and 100 mg ml−1, with respect to Gel 1/PCL NFs, Gel 10/PCL NFs, and Gel 100/PCL NFs) was mixed with 1 mg of PCL NFs, and the mixture was allowed to incubate for 30 min. This process was repeated 5 times.” (See Nguyen p. 4536, col. 2, 3rd para). As such Nguyen taught coating PCL-gelatin nanofibers with gelatin. It is also noted that Nguyen taught that “NFs were surface-engineered with multilayers of gelatin so that the cell sheets could spontaneously assemble within 3 days in cell culture plates.” (See Nguyen Abstract). It would have been obvious for a person of ordinary skill in the art to substitute the PCL-gelatin of Hwang with the PCL-gelatin scaffold taught by Nguyen. One of ordinary skill would readily recognize this as an alternative method to achieve a predictable result of enhanced cell attachment and cell growth.
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al (Biomed Mater Res A. 2016 Apr; hereinafter "Hwang;" See PTO-892) as applied to claim 1 above further in view of Nakamura et al (Tissue Eng Part C Methods. 2019 Jun; Hereinafter “Nakamura;” See PTO-892).
Regarding claims 22 and 24: As indicated above Hwang taught “[c]omposite electrospun [PCL/gelatin] scaffolds with and without craterlike structures were cut into disks with 0.5 cm diameters, briefly sterilized under UV light for 30 minutes, and then placed into 48-well plates.” As such the structure Hwang taught is interpreted to read on the claimed base material. Hwang did not teach of suggest “a gelatin particle is immobilized in a region of the base material on which the biocompatible substance is attached.”
Nakamura was directed to the utility of gelatin hydrogel nonwoven fabrics (GHNFs) as a carrier membrane in preparing multilayered cell sheets. (See Nakamura Abstract). Nakamura demonstrated that GHNFs fabrication using a blow method of gelatin solution and observed that when the cell sheet of human mesenchymal stromal cells was piled up to formulate three-layered cell sheets. Nakamura stated that “GHNF facilitates the metabolic activity of three-layered cell sheets, and the cell migration from cell sheets into the GHNF was observed. The GHNF is a promising material used to support cell sheets during the process of assemble formulation and contributes to the improved biological functions of tissue-like cell constructs.” (See Nakamura Abstract).
It would have been obvious to a person of ordinary skill in the art to use the GHNFs in place of the electrospun PCL=gelatin base material of Hwang. As Nakamura demonstrated, the GHNF was a suitable alternative for cell culture applications. Such a substitution would have yielded predictable results, namely gelatin-based scaffold capable of supporting cell culture.
Conclusion
No claim is allowed.
No claim is free of art.
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.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633