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 .
Status of Claims
Claims 53-82 are pending and examined below.
Claim Objections
Regarding claim 55, the claim reads “wherein the polymeric component having at least one”. Please correct this to read ““wherein the polymeric component has at least one”.
Regarding claim 59 - the claim reads “wherein the multisheet construct comprising at least one sheet of a decellularized tissue and at least one sheet or segment of a polymeric component”. Examiner believes this should read “wherein the multisheet construct comprises at least one sheet of a decellularized tissue and at least one sheet or segment of a polymeric component”.
Regarding claim 70, the claim reads “the active material”. Please correct this to read “the active
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 67 and 69 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 67 – the claim recites “wherein the at least one hole”. There is insufficient antecedent basis for this limitation in the claim. Please correct this to read ““wherein
Regarding claim 69, the claim contains several trademark names (Chronoflex, Biospan, Bionate, CarboSil, PurSil, Avcothane, Cardiothane). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the claimed polymer component and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 53-55, 58, 59, 61, 67-69, 72-79, 81, and 82 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2017/0360544 (Ward)
Regarding claim 53, Ward discloses a construct (Fig. 1) comprising:
at least one decellularized tissue (¶0017, wherein “extracellular matrix”, i.e. ECM, corresponds to “at least one decellularized tissue”)
at least one polymeric component (¶0017, wherein “polypropylene” corresponds to at least one polymeric component);
wherein the polymeric component at least partially penetrates at least one surface region of the decellularized tissue (¶0016, wherein “interlock the first layer and the second layer” corresponds to partially penetrates at least one surface region of the decellularized tissue)
Regarding claim 54, Ward further discloses a decellularized tissue (¶0017, “ECM”) physically associated to a polymer component (¶0016, wherein “interlock the first layer with the second layer” corresponds to a physical association), said association comprising or consisting:
at least partial penetration of the polymer component into a surface region of the tissue (¶0016, wherein the interlocked “lug and hole” configuration corresponds to “at least partial penetration of the polymer component into a surface region of the tissue”)
Regarding claim 55, Ward discloses a construct comprising:
at least one decellularized tissue (¶0017, “ECM”) and
at least one polymeric component (¶0017, wherein “polypropylene” corresponds to a polymeric component)
wherein the polymeric component having at least one surface feature protruding one face of the decellularized tissue, crossing it to the other face through at least one hole formed in the tissue (¶0016, wherein “having dimensions so that the lugs engage with a surface of the second layer” corresponds to “crossing it to the other face through at least one hole formed in the tissue”)
Regarding claim 58, Ward further discloses a multisheet construct (¶0017, wherein “10 layers” corresponds to a multisheet construct)
Regarding claim 59, Ward further discloses wherein the multisheet construct comprising at least one sheet of a decellularized tissue (¶0016, “ECM”) and at least one sheet or segment of a polymeric component (¶0017, “polypropylene”),
wherein any sheet of the decellularized tissue is adjacent to or in contact with at least one sheet or segment of the polymeric component (¶0016, wherein the lug and hole configuration corresponds to in contact with); and
wherein at least two sheets or segments of the polymeric component are associated to each other via at least one hole formed in the at least one sheet of the decellularized tissue (Fig. 1, see also ¶0016, wherein the “lug and hole” configuration corresponds to at least two sheets associated with each other)
Regarding claim 61, Ward further discloses wherein the multisheet construct (¶0016, wherein two layers corresponds to a multisheet construct) comprises a number of sheets of the decellularized tissue and same number of sheets of the polymeric component (¶0017, wherein the first sheet is ECM and the second sheet is a polymeric material)
Regarding claim 67, Ward further discloses wherein the at least one hole is pre-formed or is present in the decellularized tissue (¶0062, wherein “a piercing sheet of ECM” corresponds to at least one hole is present in the decellularized tissue, see also MPEP 2113)
Regarding claim 68, Ward further discloses wherein the decellularized tissue (¶0002, “decellularized tissues”) is selected from pericardium, bovine pericardium, swine pericardium, onentum, or small intestine mucosa (¶0002, “small intestine”)
Regarding claim 69, Ward discloses a construct (see rejection of claim 53) wherein at least one of the following is held true:
(a) the polymer component is or comprises a polymer selected amongst hydrophobic, hydrophilic, and amphiphilic polymers (¶0017, wherein polypropylene is a hydrophobic polymer)
(b) the polymer component is or comprises a blend, an IPN, or a semi-IPN;
(c) the polymer component is or comprises an acrylic or a methacrylic polymer; (d) the polymer component is or comprises a polyolefin (¶0017, wherein polypropylene is a polyolefin)
(e) the polymer component is or comprises a silicone polymer;
(f) the polymer component is or comprises a polycarbonate, a polyurethane, a polyurea or a polyamide and combinations thereof;
(g) the polymer component is or comprises a polyurethane (¶0017, “polyurethane)
(h) the polymer component is or comprises a polymer selected from polymethyl methacrylate (PMMA), poly(n-butyl methacrylate) (PBMA), poly(hexyl methacrylate) (PHMA), polystyrene (PST), poly(2-hydroxyethyl methacrylate) (PHEMA), poly(N-(2-hydroxypropyl)methacrylamide) (PHPMA), polycyanoacrylate (PCA), a polyethylene/polypropylene copolymer, a polyethylene/polybutylene copolymer, a polypropylene/polybutylene copolymer, poly-isobulyene, polydimethylsiloxane (PDMS), phenyl-containing PDMS, polyester urethanes, polyether urethanes, polycarbonate, silicone-containing polyurethanes, polyglycolic acid, polylactic acid, polycaprolactone, polylactide-caprolactone copolymer, polyglycolic acid-lactic acid copolymer, polyethylene oxide-polylactic acid copolymer, polyethylene oxide-polycaprolactone copolymer, polytetramethylene oxide-caprolactone copolymer, polyhydroxy butyrate, polyhydroxy valcrate, polyethylene adipate, polybutylene adipate, polyethylene succinate polybutylene succinate and polybutylene terephthalate and polyethylene/butylene terephthalate copolymers and combinations and copolymers thereof;
(i) the polymer component is or comprises a shape memory element;
(j) the polymer component is or comprises a polyether urethane selected from Pellethane, Elastane, Elastolan, Tecoflex, Biomer;
(k) the polymer component is or comprises a polycarbonate urethane selected from Chronoflex, Biospan and Bionate;
(l) the polymer component is or comprises a silicone-containing polyurethane selected from CarboSil, PurSil, Avcothane and Cardiothane;
(in) the polymer component is or comprises Chronoflex or Tecoflex and any combination thereof
(n) any combination thereof.
Regarding claim 72, Ward discloses a device (¶0015, tissue graft”) comprising a construct according to claim 53 (see rejection of claim 53)
Regarding claim 73, Ward further discloses the device according to claim 72 (see rejection of claim 72) configured as an implant (¶0012, wherein “implanted” corresponds to configured as an implant)
Regarding claim 74, Ward discloses a device selected from stents, metallic stents, vascular grafts, heart valves, membranes, scaling devices, suture or staple lines, hernia meshes or hernia repair devices, pelvic floor reconstruction devices, wound or burn dressings (¶0051, wherein “wound repair” corresponds to wound dressing), dural closures and cardiac patches.
Regarding claim 75, Ward discloses a process for manufacturing a construct according to claim 53 (see rejection of claim 53), the process comprising:
contacting at least one pierced surface region of at least one decellularized tissue (¶0028, “piercings in a sheet of ECM’) with at least one polymer (¶0027, wherein the lug sheet can be formed of polymeric material), and
permitting said at least one polymer to penetrate into the piercings (¶0025, “pushing the lugs of the lug sheet through the piercings of the pierced sheet”)
Regarding claim 76, Ward discloses a process further comprising at least one step selected from
(a) piercing or forming holes in a surface region of at least one decellularized tissue (¶0062, wherein “piercing a sharp of blunt needle through a sheet of ECM” corresponds to forming holes in a surface region of at least one decellularized tissue)
(b) inserting the polymer into the piercings (holes);
(c) curing the polymer;
(d) permitting said at least one polymer to penetrate into the one or more holes to thereby forming a polymeric sheet on the surface region;
(e) associating or fusing two or more constructs;
(f) thermal bonding of said at least one decellularized tissue and said at least one polymer by raising the temperature of the polymeric component above either (i) the transition temperature thereof; or, (ii) the melting temperature thereof for semi- crystalline polymers to result, at least partially, in a polymer chain entanglement along at least one region of the polymeric component;
(g) selecting the polymeric to be in a form of a layer or a coat of particles, a polymeric sheet, a polymeric film, a polymeric fiber or a polymeric mesh, a gel, a hydrogel or as a liquid or fluidic film and any combination thereof;
(h) any combination thereof.
Regarding claim 77, Ward discloses a process for manufacturing a construct comprising at least one decellularized tissue (¶0017, “ECM”) and at least one polymeric component (¶0017, wherein “polypropylene” corresponds to at least one polymeric component), the process comprising:
contacting at least one surface region of at least one decellularized tissue having been pierced (¶0062, wherein a sheet of ECM is pierced) to form one or more holes with at least one polymer (¶0076, wherein polymeric material forms the “lug sheet”) and
permitting said at least one polymer to penetrate into the one or more holes (¶0076, “interlocking lug sheet and pierced sheet together”)
Regarding claim 78, Ward further discloses at least one step selected from
(a) forming holes in a surface region of at least one decellularized tissue (¶0062, wherein “piercing a sharp of blunt needle through a sheet of ECM” corresponds to forming holes in a surface region of at least one decellularized tissue)
(b) injecting the polymer into the piercings (holes);
(c) curing the polymer;
(d) permitting said at least one polymer to penetrate into the one or more holes to thereby forming a polymeric sheet on the surface region;
(e) associating or fusing two or more constructs;
(f) thermal bonding of said at least one decellularized tissue and said at least one polymer by raising the temperature of the polymeric component above either
(i) the transition temperature thereof; or,
(ii) the melting temperature thereof for semi- crystalline polymers to result, at least partially, in a polymer chain entanglement along at least one region of the polymeric component;
(g) selecting the polymeric to be in a form of a layer or a coat of particles, a polymeric sheet, a polymeric film, a polymeric fiber or a polymeric mesh, a gel, a hydrogel or as a liquid or fluidic film and any combination thereof;
(h) any combination thereof.
Regarding claim 79, Ward further discloses wherein at least one of the following is being held true:
(a) the polymer fully penetrates through the one or more holes (¶0016, wherein “having dimensions so that the lugs engage with a surface of the second layer” corresponds to fully penetrating through the one or more holes);
(b) the polymer partially penetrates the one or more holes;
(c) the polymer fully penetrates through the one or more holes to form a polymer sheet on both faces of the surface region, to thereby form a construct assembly; and,
(d) any combination thereof.
Regarding claim 81, Ward discloses wherein said at least one decellularized tissue is dried (¶0062, wherein ECM can be dried”) before being associated with said polymeric component (¶0060, wherein polymeric materials can make up the pierced sheet)
Regarding claim 82, Ward further discloses wherein said at least one decellularized tissue (¶0062, “ECM”) is lyophilized (¶0062, wherein ECM can be lyophilized”)
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.
Claim(s) 56 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0360544 (Ward) in view of US 2017/0333604 (Cohn)
Regarding claim 56, Ward further discloses at least one decellularized tissue and at least one polymeric component (see rejection of claim 53) but doesn't explicitly teach or disclose thermal bonding.
Cohn discloses thermal bonding of at least one polymeric component (¶0063, wherein “welding” corresponds to thermal bonding).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the at least one decellularized tissue and at least one polymeric component to be thermally bonded, as taught by Cohn, in order to firm a suitably strong connection (¶0027)
Regarding claim 57, Ward discloses a construct (see rejection of claim 53) but doesn't explicitly teach or disclose thermal bonding.
Cohn discloses wherein said thermal bonding is achieved by raising the temperature of the polymeric component above either
(a) the transition temperature thereof (¶0063, wherein the polymer is heated above its transition temperature in vivo); or,
(b) the melting temperature thereof for semi-crystalline polymers;
to result, at least partially, in a polymer chain entanglement along at least one region of the polymeric component (¶0063, wherein a “weld” corresponds to polymer chain entanglement in at least one region”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the construct of Ward with thermal bonding by heating the polymeric component above the glass transition temperature, as taught by Cohn, in order to firm a suitably strong connection (¶0027)
Claim(s) 60 and 62-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0360544 (Ward) in view of US 2007/0237973 (Purdy)
Regarding claim 60, Ward discloses a sheet of decellularized tissue and a sheet of polymeric component but doesn't explicitly teach or disclose at least one sheet of decellularized tissue configured between any two sheets of polymeric component.
Purdy discloses a construct (Fig. 1, 200) wherein at least one or any of the at least one sheets of a decellularized tissue (Fig. 2, 215, ¶0032) is/are confined between any two sheets of the polymeric component (Fig. 2, wherein ECM 215 is confined between polymer layers 214 and 212)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the construct of Ward to have at least one sheet of decellularized tissue configured between any two sheets of the polymeric component, as taught by Purdy, in order to provide a graft that has both mechanical stability under continuous stress and compliance similar to that of the host tissue (¶0003).
Regarding claim 62, Ward discloses a construct comprising decellularized tissue and sheets of a polymer component (see rejection of claim 53) but doesn't explicitly teach or disclose two or more assemblies of a decellularized tissue confined between two sheets or segments of a polymer component, wherein said assemblies are associated to each other.
Purdy discloses two or more assemblies of a decellularized tissue confined between two sheets or segments of a polymer component (Fig. 2, wherein the assemblies formed by 214 – 215 – 212 and 212-211-213 correspond to an assembly with a decellularized tissue confined between two sheets of a polymer component), wherein said assemblies are associated to each other (Fig. 2, wherein the assemblies of 214-215-212 and 212-211-213 are joined together at 212, ¶0030, wherein 212 is at least one layer)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the construct of Ward with two or more assemblies of a decellularized tissue confined between two sheets or segments of a polymer component, as taught by Purdy, in order to provide a graft that has both mechanical stability under continuous stress and compliance similar to that of the host tissue (¶0003)
Regarding claim 63, Ward discloses a construct (see rejection of claim 53) but doesn't explicitly teach or disclose wherein at least two assemblies as oppositely oriented
Purdy discloses a construct (Fig. 1, 200) wherein at least two assemblies are oppositely oriented (Fig. 2, wherein the assembly formed by 214 – 215 – 212 and the assembly formed by 212 – 211 – 213 correspond to “oppositely oriented”, i.e. at least one polymeric layer confined between any two sheets of decellularized tissue)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the construct of Ward to have at least two oppositely oriented assemblies, as taught by Purdy, in order to provide a graft that has both mechanical stability under continuous stress and compliance similar to that of the host tissue (¶0003).
Regarding claim 64, Ward discloses a construct (see rejection of claim 53 but doesn't explicitly teach or disclose a wire element of metal frame
Purdy discloses a wire element or metal frame (Fig. 4, ¶0033, “metal support frame”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the construct of Ward with a metal support frame, as taught by Purdy, in order to add rigidity, expansion force or support to a prosthesis (¶0023).
Regarding claim 65, Ward discloses a construct (see rejection of claim 53) but doesn't explicitly teach or disclose wherein the metal frame is connected to said construct by at least partial coating said metal frame with the polymeric component.
Purdy discloses wherein the metal frame is connected to said construct by at least partial coating said metal frame with the polymeric component (Fig. 4, wherein stents 11 are at least partially coated with polymeric component 33)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify connecting the construct of Ward to at least partially coat a metal frame, as taught by Purdy, in order to prevent leakage through the metal frame.
Regarding claim 66, Ward discloses wherein the polymeric component is in a form of a layer or a coat of particles (¶0014, layer of polymeric material), a polymeric sheet, a polymeric film, a polymeric fiber or a polymeric mesh, a gel, a hydrogel or as a liquid or fluidic film and any combination thereof.
Claim(s) 70, 71, and 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0360544 (Ward) in view of WO 2021/067715 (Pashos)
Regarding claim 70, Ward discloses one or more sheets (see rejection of claim 53) but doesn't explicitly teach or disclose that the sheets are configured for releasing active or non-active materials.
Pashos discloses wherein one or more of the sheets (abstract, “polymer-permeated grafts”) is designed as a material reservoir for releasing active or non-active materials (¶00161, wherein “release of therapeutic and or prophylactic agent” corresponds to releasing active materials)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to configured the one or more sheets of Ward to release active or non-active agents, as taught by Pashos, in order to provide pain relief, reduce inflammation, or reduce bacteria, fungus, or microbes (¶00161).
Regarding claim 71, Ward discloses a construct (see rejection of claim 53 but doesn't explicitly teach or disclose an active material.
Pashos discloses wherein the active material is selected from analgesics; antianxiety drugs; antiarrhythmics; antibacterial agents; antibiotics; anticoagulants and thrombolytics; anticonvulsants; antidepressants; antidiarrheals; antiemetics; antifungals; antihistamines; antihypertensives; anti- inflammatories; antineoplastics; antipsychotics; antipyretics; antivirals; beta-blockers; corticosteroids; cytotoxics; hormones and sex hormones; enzymes; and vitamins (¶00161, “antibiotics, “antifungals, “anti-inflammatories”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the construct of Ward with an active agent such as an antibiotic, as taught by Pashos, in order to reduce the likelihood of bacterial infection following implantation.
Regarding claim 80, Ward discloses a process for manufacturing a construct comprising at least one decellularized tissue (¶0017, “ECM”) and at least one polymeric component (¶0017, “polypropylene”), the process comprising:
stacking one or more sheets of a decellularized tissue (¶0017, “ECM”) and one or more sheets or segments of a polymeric material (¶0017, “polypropylene”) to obtain a stacked structure (¶0016, wherein the “lug and hole” arrangement corresponds to a stacked structure)
forming holes in said stacked structure to form one or more holes in each of the one or more sheets of the tissue and polymeric material (see Fig. 5), wherein optionally at least a number of said one or more holes are coaxially arranged (see Fig. 5, wherein the holes are coaxially arranged); and
Ward doesn't explicitly teach or disclose treating said stacked structure with a liquid polymer to cause said liquid polymer to penetrate into the one or more holes and fuse said sheets to form the construct.
Pashos discloses treating said stacked structure with a liquid polymer to cause said liquid polymer to penetrate into the one or more holes and fuse said sheets to form the construct (¶0062, wherein “a curable polymer is pulled, or drawn into the structure of the tissue using a vacuum chamber” corresponds to penetrate into the one or more holes and fuse said sheets to form the construct)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify fuse the stacked structure of Ward with a liquid polymer, as taught by Pashos, in order to make the construct more robust and avoid deterioration once applied to/implanted in the body (¶0062)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAXIMILIAN TOBIAS SPENCER whose telephone number is (571)272-8382. The examiner can normally be reached M-F 8am-5pm.
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, Jerrah Edwards can be reached on 408.918.7557. 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.
/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774