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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 02/28/2022 has been entered.
DETAILED ACTION
Claims 1-6 are pending in the Claim Set filed 2/27/2026.
Claims 1-6 have been amended.
Applicants elected Group I: claims 1-14, species of polymer is polycaprolactone (PCL) and bioactive molecule is VEGF in the reply filed on 10/12/2023 without traverse.
Claims 7-37 are canceled.
Herein, claims 1-6 are for examination to the extent that they read on the elected species.
Withdrawn Rejections
The rejection of claims 1-6 under 35 U.S.C. 103 as being unpatentable over Lu et al (US20090148486, cited in IDS filed 11/06/2020) and Hackett et al (Electrospun Biocomposite Polycaprolactone /Collagen Tubes as Scaffolds for Neural Stem Cell Differentiation, Materials, p.3714, June 2010, of record) [Hackett] and Hollister et al (US 2012/0271418, of record) [Hollister], Sirimanne et al [US 2005/0080338, of record] [Sirimanne] and Qin et al (US 2018/0044629, of record) [Qin] as evidenced by SciFinder (1-Ethyl-3-[3-(dimethylamino)propyl]carbodiimide (EDC); Retrieved 12/27/2025, of record) [SciFinder] is withdrawn in favor of the New Grounds of Rejection as set forth below.
New Grounds of Rejection
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al (US20090148486, cited in IDS filed 11/06/2020) and Hackett et al (Electrospun Biocomposite Polycaprolactone /Collagen Tubes as Scaffolds for Neural Stem Cell Differentiation, Materials, p.3714, June 2010, of record) [Hackett] and Hollister et al (US 2012/0271418, of record) [Hollister] in view of Evans et al (The architecture of a collagen coating on a synthetic polymer influences epithelial adhesion, Journal of Biomedical Material, p.461, 2001) {Evans], Lu et al (US20090148486, cited in IDS filed 11/06/2020), Sirimanne et al [US 2005/0080338, of record] [Sirimanne] and Qin et al (US 2018/0044629, of record) [Qin] as evidenced by SciFinder (1-Ethyl-3-[3-(dimethylamino)propyl]carbodiimide (EDC); Retrieved 12/27/2025, of record) [SciFinder] and Yang (enhanced physicochemical properties of collagen by using EDC/NHS-crosslinking, Bull. Mater. Sci., Vol. 35, No. 5, p.913, October 2012).
Regarding claims 1-6,
Hollister teaches a scaffold composition comprising two components, wherein a synthetic polymer that is polycaprolactone and a naturally occurring polymer that is collagen (Abstract; [0100]; [0103-0107]; See entire document). Hollister teaches a scaffold, or portion or component thereof, can comprise a composite material comprising at least two components, e.g., polycaprolactone and collagen, wherein the components are separated into different layers of the scaffold (Abstract; [0100]; [0103-0107]; See entire document). Hollister teaches a scaffold, or portion or component thereof, can comprise at least one bioactive agent, wherein the bioactive agent is collagen [0132]; [0136]. Hollister teaches chemical modification methods may be used to covalently link a biomolecule, e.g. collagen, on the surface of the scaffold, or portion or component thereof. The surface functional groups of the scaffold, or portion or component thereof can be coupled with reactive functional groups of the molecules or biomolecules to form covalent bonds using coupling agents well known in the art, e.g., carbodiimides [0140]. Therefore, it would have been obvious to one of ordinary skill in the art to provide a scaffold made from polycaprolactone, wherein collagen is covalently linked on the surface (i.e., crosslinked overcoat) of the polycaprolactone scaffold using coupling agents well known in the art, e.g., carbodiimides.
Hollister teaches pores of a scaffold can allow adherence of cells, provide an open volume for seeding of cells, provide an open volume for growth factors or other additives, allow adherence of another matrix layer or serve as conduits for Vascularization. A scaffold material with a high porosity and an adequate pore size is preferred so as to facilitate cell introduction and diffusion throughout the whole structure of both cells and nutrients. Pores of a scaffold material can be engineered to be of various diameters. Particularly, Hollister teaches the scaffold has pores that have a diameter of about 100 μm to about 600 μm (e.g., about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 350 μm, about 400 μm, about 450 μm, about 500 μm, or about 550 μm). Hollister teaches that it is understood that the pores of a scaffold material can have the same, approximately the same, or different average diameters between different components [0101]. The diameters of the pore sizes as taught by Hollister lie inside or overlap with the claimed pore diameter ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05. Therefore, it would have been obvious to provide a scaffold made from polycaprolactone, wherein collagen is covalently linked on the surface of the polycaprolactone scaffold using a coupling agent, such as carbodiimides, wherein the polycaprolactone scaffold comprising an overcoating of collagen is crosslinked using carbodiimides, wherein the scaffold comprises pores having diameters of about 100 μm to about 600 μm and would have been motivated to do so because pores of a scaffold allow adherence of cells, provide an open volume for seeding of cells, provide an open volume for growth factors or other additives, wherein a scaffold material with a high porosity and an adequate pore size is preferred so as to facilitate cell introduction and diffusion throughout the whole structure of both cells and nutrients as taught by Hollister.
However, Hollister does not teach using crosslinking collagen comprising collagen I and III to coat a synthetic polymer.
Evans cures the deficiency.
Evans teaches the architecture of a collagen coating on a synthetic polymer influences epithelial adhesion (Title), wherein the collagen coating comprises collagen I and collagen II, wherein the collagen coating is crosslinked on the surface of a synthetic polymer, e.g., polycarbonate having pore size of 400 nm., that is used as a model substrate to demonstrate the efficiency crosslinking of collagen comprising collagen I and II (p.462, right col.; Collagen coatings, p.462, right col, p.463, left col.). Evans teaches that crosslinked collagen coating showed an even coating of collagen over the membrane (results, p.463, right col.). Evans teaches the crosslinked collagen coatings supported the basal cell membrane of the overlying epithelial cells across the places where pores opened onto the polymer surface, of which was superior to an uncoated and covalently immobilized collagen directed to a synthetic polymer (p.466, left col. bottom – right col., top), wherein ultrastructural data revealed the formation of sheaflike structures associated with the coating of crosslinked collagen p.466, right col. bottom). Evans teaches the assembly of anchoring fibrils was only identified on the coating treatment that involved the presence of a crosslinked collagen, wherein this surface treatment using collagen comprising collagen I and III was the most conducive to the formation of a combination of the epithelial adhesive structures, e.g., hemidesmosomal plaque, basal lamina, and anchoring fibrils. Moreover, Evans teaches, undoubtedly, the characteristics of the crosslinked collagen coating that permitted such remarkable formation of epithelial adhesive structures are multifactorial and likely include structural, scaffold, and conformation effects, as well as the stability provided by chemical crosslinking of the collagen (p.467, left col.).
Accordingly, one skilled in the art would have recognized the advantages of providing crosslinked collagen comprising collagen I and collagen III to provide an overcoating coat on the surface of a synthetic polymer and would have been motivated to do so in view of the teachings of Evans to preferentially coat the surface of a synthetic by using the method of crosslinking collagen as opposed to the alternative method of immobilization of collagen.
Hollister and Evans do not teach the ratio of Col-1 to Col-3 is between about 0.5 and about 3.5 (or, the ratio of Col-1 to Col-3 is between about 0.9 and about 2.3), wherein the scaffold is a breast implant, a vascular endothelial growth factor ((VEGF) (elected species: pro-angiogenic bioactive biomolecules), wherein the acellular breast implant bioscaffold (i.e., structure) is lyophilized and crosslinked with 1-Ethyl-3-(3-dimethylaminopropyl)carboiimide (EDAC).
However, Lu, Sirimanne, Qin as evidenced by SciFinder, and Yang, as a whole, cures the deficiencies.
Lu teaches a composition comprising (a) scaffold of (i) an electrospun collagen mesh, (xiii) synthetic three-dimensional scaffold material, (xiv) a caprolactone polymer (elected species: polymer), a mesh fabric and any combination thereof, and at least one growth factor [0026]. Lu teaches a composition disclosed herein comprises vascular endothelial growth factor ((VEGF) (elected species: pro-angiogenic bioactive biomolecules)
Lu teaches scaffolds can be of natural or synthetic materials, and may be permanent, biodegradable, bioerodable or bioresorbable. Examples of natural scaffold materials include collagen and glycosaminoglycans such as hyaluronic acid. Commonly used synthetic bioerodable scaffold materials include polylactic acid (PLA), polyglycolic acid (PGA); poly (lactide-co-glycolide) (PGLA) and polycaprolactone (PCL), wherein scaffolds generally have a high porosity to facilitate cell seeding and diffusion throughout the structure [0084].
Lu teaches that a matrix serving as a scaffold is typically a structure which can contain one or more structural components, for example collagen, and/or one or more other components such as cellular proteins, growth factors, etc. [0085]. Moreover, Lu teaches that the matrix is acellular is laden with biomolecules [0106]. Further, Lu teaches a matrix comprising a synthetic three-dimensional scaffold material, wherein the scaffolds comprise natural or synthetic materials of which may be permanent, biodegradable, bioerodable or bioresorbable, examples of natural scaffold materials include collagen and polycaprolactone, wherein the matric is an acellular matrix, wherein the matrix comprises type I collagen and type III collagen, wherein a ratio of type I collagen to type III collagen is 30%: 70%, 55:45%, 45%:55%, or 70%:30% [0009-0010] ] (i.e., ratios: 1:2.3; 1.2:1; 1:1.2; 2.3:1, respectively).
The ratios of collagen I and Collagen III as taught by Lu lie inside or overlap with the claimed ratios. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide an acellular matrix bioscaffold composition. In addition, a ratio of type I collagen to type III collagen is 30%: 70%, 55:45%, 45%:55%, or 70%:30% (i.e., ratios: 1:2.3; 1.2:1; 1:1.2; 2.3:1, respectively), as taught by the prior art renders obvious the recitation of a ratio of Col-1 to Col-3 between about 0.5 and about 3.5 (instant claim 2). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further include VEGF (elected species: pro-angiogenic bioactive biomolecules) in the acellular matrix bioscaffold composition in view of the overall teachings of and as distinctively taught by Lu. Additionally, Lu describes the term ‘mesh’ to mean any material in any form including, for example, knotted, braided, extruded, stamped, knitted, woven, non-woven or otherwise, and may include a material with a substantially regular and/or irregular patterns, wherein a mesh can be a cross-linked fiber mesh, a nanofiber mesh, a mesh fabric, biodegradable polymer mesh, or a combination of any of the foregoing. A mesh can be non-degradable, degradable or biodegradable ([0026]; [0086]; [0119]; [0126]; claim 24).
Sirimanne teaches a breast implant made up of collagen and polycaprolactone that provides for ingrowth of fibrous tissue into and replacing the resorbable material, wherein the implants further contain a medicinal, therapeutic, or diagnostic substance. Furthermore, Sirimanne teaches that the collagen is crosslinked (Abstract; [0030-0057], Figures 1-5; claims 1-15; See entire document). Accordingly, in view of the teachings of Sirimanne those skilled in the art would be motivated to provide a breast implant made from collagen and PCL having a reasonable expectation of success, wherein the collagen is crosslinked. Therefore, making it prima facie obvious to provide an acellular breast implant bioscaffold composition comprising collagen and polycaprolactone (PCL).
Qin teaches biologically functional scaffolds having a porous structure comprising seeding cells using the scaffolds (Abstract; [0002-0033]; Figs. 1-29). Qin teaches the scaffold is an implant configured to be implanted in vivo, wherein the biologically functional scaffold may be twisted, folded, rolled, molded, placed and/or inserted into or on the defect such as comprising breast after lumpectomy or mastectomy or wrapped around the defect of bone, cartilage or soft tissue [0034]. Qin teaches the biologically functional scaffold and/or implant comprises pores having an average diameter from about 20 μm to 500 μm, of which overlaps with the claimed pore size of 100-500 μm [0055]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05. Qin teaches the biologically functional scaffold and/or implant comprises fibers and/or sheets. In some embodiments, the biologically functional scaffold and/or implant is made from collagen fiber, collagen fiber bundle dimensions or diameters more similar to its natural state [0057]. Qin teaches the fiber and/or fiber bundle dimension (e.g., diameter, or width, and length) of preferred scaffolds and/or implants of the present invention may support a framework with opened pore structure and with a network of fibers, fiber bundles and/or sheets that may provide a relatively strong and stable framework, wherein the scaffold and/or implant allows for biocompatible cellular and tissue response and good volume retention after implantation in an animal, wherein the biologically functional scaffold and/or implant is in a form of a pocket, comb, hollow cylinder, triangular pyramid, rod, sheet, cube, tube, cup, concave, crescent, particle, sphere, ellipsoid, wedge, or ribbon [0057-0061]. Qin teaches the biologically functional scaffold and/or implant comprises VEGF [0064]. Further, Qin teaches a method of repairing a defect(s) in a tissue comprising implanting the biologically functional scaffold and/or implant at the site of defect, wherein the tissue with the defect is breast and/or dental socket. Qin teaches cells are seeded onto the biologically functional scaffold and/or implant, wherein the cells comprise fibroblasts (i.e., pulp), epithelial cells (i.e., breast), and/or vascular endothelial cells [0084-0087] (Qin: claims 137-140; See entire document). Qin teaches scaffold and/or implant with one or more treatment solutions before or after freezing drying, and/or freeze drying (i.e., reads on lyophilized) (or before or after other methods for drying the scaffold, besides freeze drying, such as air dry or drying in a drying oven at a pre-set temperature). In some embodiments, the treatment is solution comprises a chemical crosslinking agent, wherein the crosslinking agent is EDC ([0049-52]; [0057]; [0063]; see entire document). As evidenced by Scifinder, EDC is a another name or identifier for 1-Ethyl-3-(3-dimethylaminopropyl)carboiimide (EDAC) (Scifinder at page 1; See Section: Other Names and Identifiers). Qin teaches with specific regard to non-naturally occurring crosslinkers or carriers, in some embodiments, as indicated above, the dispersed soft tissue and/or biologically functional scaffold described herein may optionally include the addition of a non-naturally occurring crosslinkers, also referred to herein as crosslinking agents, in addition to the natural crosslinker(s) and natural carrier(s) from the one or more soft tissue(s) after dispersing the soft tissue, wherein the optionally added non-naturally occurring crosslinker includes EDC [0049]. Moreover, Qin teaches, in some embodiments, the method described herein may also comprise treating said biologically functional scaffold and/or implant with one or more treatment solutions after freezing, drying, and/or freeze drying before implantation. In some embodiments, the treatment solution comprises a chemical crosslinking agent, e.g., EDC [0063]. Moreover, preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971), See MPEP 2123 Section II. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments; Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), 493 U.S. 975 (1989) See MPEP 2123 Section I. Accordingly, one skilled in the art would not be expected to rely only on preferred embodiments of the references.
Accordingly, one skilled in the art would have been motivated to provide a scaffold comprising polycaprolactone having an overcoating of collagen, wherein crosslinking the collagen is expected to effectively stabilize the underlying scaffold and/or implant having a reasonable expectation of success.
At last, since the prior art teaches an acellular implant bioscaffold that is structurally the same as that claimed, it would necessarily follow that it must be capable of performing as a breast implant, as a composition and its properties are inseparable.
Accordingly, a breast implant (i.e., structure) comprising polycaprolactone having an overcoating that is collagen comprising collagen I and III that provides for ingrowth of fibrous tissue into and replacing the resorbable material, wherein the breast implant structure containing a medicinal, therapeutic, or diagnostic substance, e.g, VEGF (elected species: pro-angiogenic bioactive biomolecules), would have been prima facie obvious for one of ordinary skill in the art to provide before the effective filing date of the claimed invention. Moreover, one skilled in the art would have recognized the advantages that a biologically functional scaffold and/or implant comprising a crosslinked collagen that is overcoat over a synthetic polymer: polycaprolactone, in the form of a cup and/or sphere, of which can be used to repair a defect of breast (i.e., breast after lumpectomy or mastectomy) as made obvious by the cited references.
Yang teaches porous structure of collagen type 1 was largely preserved and adjusted by crosslinking treatment. Furthermore, crosslinked collagen samples showed significantly reduced swelling ratio and increased resistance against thermal treatment and enzymatic degradation compared to non-crosslinked samples (Abstract; See entire document). Moreover, the degree of crosslinking can be controlled by using varying concentration of EDC (Materials, p.1; Results and discussion, p.915; Conclusions, p.918). Thus, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide an acellular breast implant bioscaffold structure comprising a crosslinked collagen overcoat of polycaprolactone, wherein the implant is provided for repairing a defect in the breast and that the scaffold is freeze dried (i.e., lyophilized) and crosslinked with Ethyl-3-(3-dimethylaminopropyl)carboiimide (EDAC) (i.e., EDC) in view the combined teachings of references, thereby making it prima facie obvious for one skilled in the art having reasonable expectation of providing an acellular breast implant bioscaffold structure, without undue experimentation. One skilled in the art would have been motivated to do so because a breast implant made up of polycaprolactone (PCL) having a crosslinked overcoating of collagen (e,g., overcoating containing collagen I/III) and polycaprolactone (PCL) as a synthetic polymer, wherein the crosslinked collagen overcoat would be expected to provide a breast bioscaffold structure so that crosslinked collagen provides excellent cell adhesion properties and the crosslinked collagen overcoat improves the biocompatibility of PCL while preserving the mechanical strength of the structure, such that the PCL synthetic polymer provides no toxic effects from its degradation products, and crosslinked collagen overcoat provides an open volume for seeding of cells and for growth factors , e.g., VEGF, or other additives. Moreover, one skilled in art would have been motivated to provide crosslinked over coating of collagen because a crosslinked collagen coated would be expected to significantly reduce swelling ratio and increased resistance against thermal treatment and enzymatic degradation compared to non-crosslinked as taught by Yang. Moreover, one skilled in the art would have been motivated to provide a crosslinked coating collagen, since it would have been well within the purview of one skilled in the art to optimize the degree of crosslinking by adjusting the amount of crosslinker used, thereby providing a controlled delivery system wherein the release profile of the VEGF can be tailored for desired goal for specific medical applications.
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Accordingly, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the cited references, as a whole.
Response to Arguments
Applicants argue that the teachings of record do not render the claimed structures with a polymer having a collagen overcoat as unpatentable.
Applicants argue that Lu is directed to materials intended to support tissue ingrowth for dental applications and repairs. Various substrate materials, such as collagen, collagen blends and polymeric materials, are suggested therein. Lu, however, does not describe a scaffold structure that is formed from a polymeric material that is subsequently coated with a collagen blend with crosslinking. There is no suggestion or motivation to modify the teachings in Lu to produce such a structure. Electrospun tubes that are formed from blended liquid formulations are materially different from polymeric materials having an overcoat. Hollister is cited for scaffolds having a particularly porous structure. Sirimanne and Qin are introduced to show incorporation of therapeutic agent and/or seeding cells. Qin is also considered to be relevant as to cross-linking with EDAC and lyophilization. Applicants argue that the teachings of record do not render the claimed structures with a polymer having a collagen overcoat as unpatentable.
Applicants. arguments have been fully considered but they are not persuasive, because the newly formulated grounds of rejection address these arguments. In particular, one skilled in the art in view of Hollister, Evans, Lu, Sirimanne, Qin and Yang, as a whole would have recognized the many advantages that would be provided by providing an acellular breast implant structure comprising a crosslinked collagen overcoat (as described above) on polycaprolactone (PCL). Moreover, Evans clearly provides one skilled in the art to provide a breast implant structure comprising crosslinked collagen in view of many benefits in comparison to immobilized collagen or an uncoated PCL breast implant.
Further, along these lines, one skilled in the art would have looked to Qin that teaches freeze drying (i.e., reads on lyophilized) the scaffold and/or implant and further treating it with a solution that comprises a chemical crosslinking agent, e.g., EDC (i.e., 1-Ethyl-3-(3-dimethylaminopropyl)carboiimide (EDAC). Furthermore, Lu and Yang teaches address using vascular endothelial growth factor ((VEGF) (elected species: pro-angiogenic bioactive biomolecules) in an implant. Moreover, one skilled in the art would have been motivated to provide a crosslinked collagen overcoat on PCL, since one skilled in the art could optimize the degree of crosslinking of collagen by adjusting the amount of crosslinker used, thereby providing a controlled delivery system wherein the release profile of VEGF can be tailored for specific breast medical conditions, of which would not be applicable for a PCL implant structure without a crosslinked collagen overcoat. As described above, one skilled in art would have been motivated to provide a crosslinked overcoating of collagen because a collagen coating is expected to significantly reduce swelling ratio and increased resistance against thermal treatment and enzymatic degradation compared to non-crosslinked as exemplified by the combination of the teachings of the cited references.
Noteworthy, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusions
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-270-1307. The examiner can normally be reached Monday-Friday 10:30am-6:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
Prosecution Insights