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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 35-38, 42, 45-49, and 52 are objected to because of the following informalities: The term “about” recited in the claims do not provide an exactitude, but rather a contemplated variation. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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 38 recites the broad recitation a thickness of about 40 to 200 microns, and the claim also recites a thickness of about 40 to 50 microns, which is the narrower statement of the range/limitation. 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 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.
Claims 34-53 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 2023/0256134 A1 – CN Apr. 14, 2021) (Zhao” herein) and further io view of Mentzer et al. (US 2018/0311403 A1) (“Mentzer” herein).
Claim 34.
Zhao discloses a bioadhesive polymer comprising:
polymer; [0012-0018, 0031-0032]
tannic acid; [0030, 0050] and
water, [0065, 0100]
wherein the polymer has a controlled degradation rate that is dependent on an amount of tannic acid present in the polymer. [0044-0045, 0050]
Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP) .
Mentzer teaches the above limitation (See paragraphs 0014, 0054, 0072, 0016 -0017 → Mentzer teaches this limitation in that the bioadhesive, pectin-based polymer compositions that include a complex of high-methoxyl pectin (HMP). The bioadhesive composition is in the form of a moldable film having a thickness of about 40 microns to 3000 mm, the bioadhesive pectin-based polymer composition biodegrades within about seven days. Thus, pectins are often defined by their source, e.g., citrus pectin (which is used in the examples described herein. The proportion of galacturonic acid residues in the methyl ester form determined the degree of methoxylation. High-methoxyl pectins (HMP) are defined herein as those pectins with a degree of methoxylation greater than 50%. The bioadhesive composition can further include one or more active agents can include one or more growth factors, e.g., one or more of transforming growth factor alpha (TGF-a) and TGF-β, tumor necrosis factor-alpha (TNF-α), vascular endothelial growth factor (VEGF), leukemia inhibitory factor (LIF), interleukins such as IL-1 through IL-7, colony-stimulating factors such as macrophage colony-stimulating factor (m-CSF), granulocyte colony-stimulating factor (G-CSF), and granulocyte macrophage colony-stimulating factor (GM-CSF), fibroblast growth factor (FGF), epidermal growth factor (EGF), insulin-like growth factor, connective tissue growth factor (CTGF), hepatocyte growth factor (HGF), Angiopoietin-1-4, and platelet-derived growth factor (PDGF). The one or more active agents can include one or more of heparin, tissue plasminogen activator (tPA), aspirin, ibuprofen, ketoprofen, non-steroidal anti-inflammatory drugs, hormones, cytokines, osteogenic factors, chemotactic factors, proteins and peptides that contain an arginine-glycine-aspartate (“RGD”) motif, analgesics, anesthetics, norepinephrine, epinephrine, phenylpropanolamine, dopamine, metaraminol, methoxamine, ephedrine, propylhexedrine, fibrillar collagen, thrombin, fibrin, a chemotherapy agent, and an immunotherapy agent.) for the purpose of providing pectin-based polymer compositions form of a hydrogel with strong bioadhesion to the mesothelial tissue of the lung. The examples below demonstrate that this bioadhesive property can be utilized to create a strong adhesive “patch” to seal holes in the lung tissue and stop air leaks. Thus, the pectin-based polymers can be used intraoperatively to cover and seal damaged areas of the lung that leak air. [0069]
Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify Zhao, with the above limitation, as taught by Mentzer to utilized to create a strong adhesive “patch” to seal holes in the lung tissue and stop air leaks.
Claim 35.
Zhao discloses the bioadhesive polymer of claim 34,
Wherein polymer is present at an initial concentration of about 1% w/w to about 10% w/w; or wherein polymer is present at an initial concentration of about 3% w/w; and
wherein tannic acid is present at an initial concentration of about 0.2% w/w to about 2% w/w. [0019-0020, 0030-0032, 0050] Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP). (Same as claim 34)
Claim 36.
Zhao discloses the bioadhesive polymer of claim 34, wherein water is present at an initial concentration of about 1% w/w to about 10% w/w; or wherein water is present at an initial concentration of about 5% w/w. [0065, 0100-010, 00137-0138] Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film. (Same as claim 34)
Claim 37.
Zhao discloses the bioadhesive polymer of claim 34, wherein the polymer has a degradation half-life ranging from about 20 hours to about 200 hours. [0050] Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP) wherein the degradation is facial erosion. (Same as claim 34)
Claim 38.
Zhao discloses the bioadhesive polymer of claim 34. Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film , wherein the pectin-based polymer film has a thickness of about 40 to 200 microns; or wherein the pectin-based polymer film has a thickness of about 40 to 50 microns. (Same as claim 34)
Claim 39.
Zhao discloses the bioadhesive polymer of claim 34., Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film, wherein the polymer comprises one or more active agents; and
wherein the one or more active agents comprise an anti-thrombotic agent, an anti-inflammatory agent, a hormone, a cytokine, an osteogenic factor, a chemotactic factor, a protein or peptide that contain an arginine-glycine-aspartate ("RGD") motif, an analgesic, an anesthetic, a vasoconstrictor, a clotting factor, a chemotherapy agent, an immunotherapy agent, a growth factor, or a combination thereof. (Same as claim 34)
Claim 40.
Zhao discloses the bioadhesive polymer of claim 39, Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film, wherein the anti- thrombotic agent is heparin, tissue plasminogen activator (tPA), or a combination thereof;
wherein the anti-inflammatory agent is aspirin, ibuprofen, ketoprofen, a non-steroidal anti-inflammatory drug, or a combination of thereof; and
wherein the vasoconstrictor is norepinephrine, epinephrine, phenylpropanolamine, dopamine, metaraminol, methoxamine, ephedrine, propylhexedrine, fibrillar collagen, thrombin, fibrin, or a combination thereof. (Same as claim 34)
Claim 41.
Zhao discloses the bioadhesive polymer of claim 39. Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film, wherein the growth factor comprises transforming growth factor alpha (TGF-α), TGF-ß, tumor necrosis factor-alpha (TNF-α), vascular endothelial growth factor (VEGF), leukemia inhibitory factor (LIF), interleukins, IL-1 through IL-7, colony-stimulating factors, macrophage colony-stimulating factor (m-CSF), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), fibroblast growth factor (FGF), epidermal growth factor (EGF), insulin-like growth factor, connective tissue growth factor (CTGF), hepatocyte growth factor (HGF), angiopoietin-1-4, platelet- derived growth factor (PDGF), or any combination of distinct growth factors thereof.. (Same as claim 34)
Claim 42.
Zhao discloses the bioadhesive polymer of claim 34. Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP), wherein the HMP is a citrus HMP having a degree of methoxylation greater than about 50%; and wherein the pectin-based polymer film is a moldable film. (Same as claim 34)
Claim 43.
Zhao discloses the bioadhesive polymer of claim 34 . Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP), wherein the bioadhesive, pectin-based polymer film binds to a mesothelial tissue; and wherein the mesothelial tissue comprises a mesothelial tissue from a visceral organ. (Same as claim 34)
Claim 44.
Zhao discloses a method of sealing a wound of a subject in need thereof, the method comprising:
providing a bioadhesive polymer comprising :
polymer; [0012-0018, 0031-0032]
tannic acid; [0030, 0050] and
water, [0065, 0100]
wherein the bioadhesive polymer has a controlled degradation rate that is dependent on an amount of tannic acid present in the bioadhesive polymer. [0044-0045, 0050]
. Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP) covering in an injured mesothelial tissue and contacting the wound with the bioadhesive pectin-based polymer film; and applying pressure to the bioadhesive pectin-based polymer film, thereby sealing the wound in the injured mesothelial tissue of the subject,
Mentzer teaches the above limitation (See paragraphs 0014, 0054, 0072, 0016 -0017, 0066 → Mentzer teaches this limitation in that the bioadhesive, pectin-based polymer compositions that include a complex of high-methoxyl pectin (HMP). The bioadhesive composition is in the form of a moldable film having a thickness of about 40 microns to 3000 mm, the bioadhesive pectin-based polymer composition biodegrades within about seven days. Thus, pectins are often defined by their source, e.g., citrus pectin (which is used in the examples described herein. The proportion of galacturonic acid residues in the methyl ester form determined the degree of methoxylation. High-methoxyl pectins (HMP) are defined herein as those pectins with a degree of methoxylation greater than 50%. The bioadhesive composition can further include one or more active agents can include one or more growth factors, e.g., one or more of transforming growth factor alpha (TGF-a) and TGF-β, tumor necrosis factor-alpha (TNF-α), vascular endothelial growth factor (VEGF), leukemia inhibitory factor (LIF), interleukins such as IL-1 through IL-7, colony-stimulating factors such as macrophage colony-stimulating factor (m-CSF), granulocyte colony-stimulating factor (G-CSF), and granulocyte macrophage colony-stimulating factor (GM-CSF), fibroblast growth factor (FGF), epidermal growth factor (EGF), insulin-like growth factor, connective tissue growth factor (CTGF), hepatocyte growth factor (HGF), Angiopoietin-1-4, and platelet-derived growth factor (PDGF). The one or more active agents can include one or more of heparin, tissue plasminogen activator (tPA), aspirin, ibuprofen, ketoprofen, non-steroidal anti-inflammatory drugs, hormones, cytokines, osteogenic factors, chemotactic factors, proteins and peptides that contain an arginine-glycine-aspartate (“RGD”) motif, analgesics, anesthetics, norepinephrine, epinephrine, phenylpropanolamine, dopamine, metaraminol, methoxamine, ephedrine, propylhexedrine, fibrillar collagen, thrombin, fibrin, a chemotherapy agent, and an immunotherapy agent. The first step in the process of bioadhesion to, or sealing of, a mesothelial tissue injury is to provide intimate contact between the pectin-based polymer compositions and the mesothelial tissue for at least about 1, 2, or 3 minutes with slight pressure. This phase increases the contact area between the surfaces.) for the purpose of providing pectin-based polymer compositions form of a hydrogel with strong bioadhesion to the mesothelial tissue of the lung. The examples below demonstrate that this bioadhesive property can be utilized to create a strong adhesive “patch” to seal holes in the lung tissue and stop air leaks. Thus, the pectin-based polymers can be used intraoperatively to cover and seal damaged areas of the lung that leak air. [0069]
Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify Zhao, with the above limitation, as taught by Mentzer to utilized to create a strong adhesive “patch” to seal holes in the lung tissue and stop air leaks.
Claim 45.
Zhao discloses the method of claim 44, wherein the polymer is present at an initial concentration of about 1% w/w to about 10% w/w; or wherein the polymer is present at an initial concentration of about 3% w/w. [0019-0020, 0030-0032, 0050] Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP). (Same as claim 44)
Claim 46.
Zhao discloses the method of claim 44, wherein the tannic acid is present at an initial concentration of about 0.2% w/w to about 2% w/w. Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP). (Same as claim 44)
Claim 47.
Zhao discloses the method of any one of claim 44, wherein the water is present at an initial concentration of about 1% w/w to about 10% w/w; or wherein the water is present at an initial concentration of about 5% w/w. [0065, 0100-010, 00137-0138]
Claim 48.
Zhao discloses the method of any one of claim 44, wherein the bioadhesive polymer has a degradation half-life ranging from about 20 hours to about 200 hours;. [0050] Zhao however does not explicitly discloses the bioadhesive polymer as a pectin-based polymer film and the polymer as a high-methoxyl pectin (HMP) wherein the degradation is facial erosion. (Same as claim 44)
Claim 49.
Zhao discloses the method of any one of claim 44. Zhao however does not explicitly disclose the bioadhesive polymer as the bioadhesive pectin-based polymer film has a thickness of about 40 to 3,000 microns. (Same as claim 44)
Claim 50.
Zhao discloses the method of any one of claim 44. Zhao however does not explicitly disclose the bioadhesive polymer as the bioadhesive pectin-based polymer film wherein the bioadhesive pectin-based polymer film comprises one or more active agents. (Same as claim 44)
Claim 51.
Zhao discloses the method of any one of claim 50. Zhao however does not explicitly disclose the bioadhesive polymer as the bioadhesive pectin-based polymer film wherein the one or more active agents comprise an anti- thrombotic agent, an anti-inflammatory agent, a hormone, a cytokine, an osteogenic factor, a chemotactic factor, a protein or peptide that contain an arginine-glycine- aspartate ("RGD") motif, an analgesic, an anesthetic, a vasoconstrictor, a clotting factor, a chemotherapy agent, an immunotherapy agent, a growth factor, or any combination of distinct active agents thereof. (Same as claim 44)
Claim 52.
Zhao discloses the method of any one of claim 44. Zhao however does not explicitly disclose the bioadhesive polymer as the bioadhesive pectin-based polymer film wherein, wherein the HMP is a citrus HMP having a degree of methoxylation greater than about 50%. (Same as claim 44)
Claim 53.
Zhao discloses the method of any one of claim 44. Zhao however does not explicitly disclose the bioadhesive polymer as the bioadhesive pectin-based polymer film wherein the injured mesothelial tissue comprises a mesothelial tissue from a visceral organ. (Same as claim 44)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Campbell et al. (US 2021/0128662 A1) COMPOSITIONS AND METHODS RELATED TO RHAMNUS PRINOIDES (GESHO) EXTRACT FOR THE INHIBITION OF POLYMICROBIAL BIOFILM FORMATION, Hwang et al. (US 2017/0072091 A1) HYDROGEL INCLUDING SURFACE-TREATED NANOFIBER AND PREPARATION METHOD THEREOF and Aslberg et al. (US 2020/0129660 A1) BIOADHESIVE HYDROGELS.
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/SILVANA C RUNYAN/Primary Examiner, Art Unit 1616 09/23/2026
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