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 . 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.
Information Disclosure Statement
The information disclosure statement filed 07/28/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. A copy of Pokrywczynska et al., Experimental Biology and Medicine, 239(3): 264-271 (2014) was not provided. Additionally, “In vitro Response of Human Buccal Epithelial Cells to a Bladder Patch for Vesicovaginal Fistula Repair” by Ilaha Isali et al. was provided but not cited on an Information Disclosure Statement.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 5-6 and 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 1 is directed to a tissue repair patch comprising chorion and amniotic tissue. Under the broadest reasonable interpretation, the claim is not markedly different from its naturally occurring counterpart, the amniotic sac (i.e., amniotic membrane). The amniotic sac includes two primary layers of tissue, amnion (i.e., amniotic tissue) and chorion, wherein amnion tissue is the innermost layer of the amniotic sac (see Koob US 2016/0199537 A1; paragraph [0039]). As claimed, there is no difference in the characteristics (structural, functional, or otherwise) between the claimed tissue patch and naturally occurring amniotic sac. Claims 2, 5-6, and 9-11. Are directed to features of the tissue patch which do not include additional elements that are sufficient to amount to significantly more than the juridical exception because the claims do not recite any additional elements that indicate that the patch results in a markedly different structural characteristic tissue patch than naturally occurring amniotic sac. Specifically with regards to claim 5, naturally occurring amniotic sac includes an inner layer of amnion (i.e., amniotic tissue) includes a single layer of epithelial cells. The tissue patch of claim 5 with epithelial cells seeded on the inner side of the tissue patch is not markedly different than naturally occurring amniotic sac that naturally occurs with a layer of epithelial cells.
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.
Claims 1-7, 11-12, 14-18, 20 and 23 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Koob (US 2016/0199537 A1).
Referring to claim 1: Koob teaches a tissue repair patch having an outer side and an inner side, comprising a structural component comprising collagen and/or chorion and regenerative component comprising amniotic tissue (see paragraphs [0038]-[0041] and [0058]-[0062]).
Referring to claim 2: Koob further teaches the structural component and the regenerative component are in separate adjacent layers, with the structural component being on the outer side and the regenerative component being on the inner side (see paragraphs [0038]-[0041] and [0058]-[0062]).
Referring to claim 3: Koob further teaches the structural component is adhered to the regenerative component using a glue comprising sodium hyaluronate, dextran, and bovine serum albumin (see paragraphs [0072]-[0076]; wherein the layers can be cross-linked (i.e., glued) together using an oxidized dextran).
Referring to claim 4: Koob further teaches the structural component and the regenerative component are mixed together in a single layer (see paragraphs [0077]-[0078] and [0092]).
Referring to claim 5: Koob further teaches epithelial cells seeded on the inner side of the tissue repair patch (see paragraph [0039], [0041] and [0047]; wherein the amnion layer includes a layer of epithelial cells).
Referring to claim 6: Koob further teaches the epithelial cells are oral or urogenital epithelial cells (see paragraph [0039], [0041] and [0047]; wherein the amnion layer includes a layer of epithelial cells from amniotic sac).
Referring to claim 7: Koob further teaches a biocompatible polymer layer on the outer side of the tissue repair patch (see paragraph [0061]; wherein patch includes one or more additional layers of biocompatible polymers).
Referring to claim 11: Koob further teaches the tissue repair patch has a size ranging from 4 cm2 to 100 cm2 (see paragraph [0131]).
Referring to claim 12: Koob further teaches one or more growth factors on the inner and/or outer side of the tissue repair patch (see paragraphs [0042]-[0043], [0114] and [0119]).
Referring to claim 14: Koob teaches a method of tissue repair, comprising positioning a tissue repair patch on a tissue wound or defect of a subject (see paragraphs [0095]-[0098] and [0105]-[0106]), the tissue repair patch having an outer side and an inner side, comprising a structural component comprising collagen and/or chorion and regenerative component comprising amniotic tissue (see paragraphs [0038]-[0041] and [0058]-[0062]).
Referring to claim 15: Koob further teaches the structural component and the regenerative component of the tissue repair patch are in separate adjacent layers, with the structural component being on the outer side and the regenerative component being on the inner side (see paragraphs [0038]-[0041] and [0058]-[0062]).
Referring to claim 16: Koob further teaches the structural component and the regenerative component of the tissue repair patch are mixed together in a single layer (see paragraphs [0077]-[0078] and [0092]).
Referring to claim 17: Koob further teaches the tissue repair patch further comprising- epithelial cells seeded on the inner side of the tissue repair patch (see paragraph [0039], [0041] and [0047]; wherein the amnion layer includes a layer of epithelial cells).
Referring to claim 18: Koob further teaches the tissue repair patch further comprises a biocompatible polymer layer on the outer side of the tissue repair patch (see paragraph [0061]; wherein patch includes one or more additional layers of biocompatible polymers).
Referring to claim 20: Koob further teaches the tissue wound or defect is a genitourinary tissue wound or defect (see paragraph [0105]-[0106] and [0111]).
Referring to claim 23: Koob further teaches the tissue repair patch is adhered or stitched to the tissue wound or defect (see paragraphs [0041], [0095]-[0098] and [0105]-[0106]; wherein it is clear that the patch is adhered to the tissue wound or defect in order to promote wound or defect healing).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Koob, as applied to claim 7 above, in view of Soares De Costa et al. (US 2014/0012395 A1) (Costa).
Referring to claim 8: Koob is silent to the polymer layer comprises polycaprolactone (PCL). Costa teaches a patch formed of any suitable material for repair or augmentation of a soft tissue defect, the material including a polymer comprising polycaprolactone (see paragraph [0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the polymer material of Koob out of polycaprolactone like taught by Costa since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Koob, as applied to claim 1 above.
Referring to claim 9: Koob further teaches the collagen of the tissue patch has a modulus of elasticity (MPa) of at least about 50 MPa (see paragraph [0036]; claim 16) but is silent to the modulus of elasticity of the tissue patch specifically ranging from 0.1 MPa to 10 MPa. There is no evidence of record that establishes that changing the modulus of elasticity of the tissue patch would result in a difference in function of the Koob device. Further, a person having ordinary skill in the art before the effective filing date of the claimed invention, being faced with modifying the modulus of elasticity of the tissue patch of Koob would have a reasonable expectation of success in making such a modification based on the desired medical application and/or surgical need and procedure; and it appears the device would function as intended being given the claimed modulus of elasticity. Lastly, applicant has not disclosed that the claimed ranges solves any stated problem, indicating that the elasticity is based on the tissue being treated, offering other acceptable ranges (see specification as originally filed paragraph [0030] “If treating stiffer tissue such as a tendon or ligament, even higher elasticity values, up to 500 MPa, can be used”) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to modify the modulus of elasticity of Koob to have an elasticity ranging from 0.1 MPa to 10 MPa as an obvious matter of design choice within the skill in the art based on the desired medical application and/or surgical need and procedure.
Referring to claim 10: Koob further teaches that the patch has a thickness that is variable depending on the desired medical application and/or surgical need and procedure (see paragraph [0064]). Koob is silent to the tissue repair patch having a thickness specifically ranging from 0.1 mm to 3 mm. There is no evidence of record that establishes that changing the thickness of the tissue patch would result in a difference in function of the Koob device. Further, a person having ordinary skill in the art before the effective filing date of the claimed invention, being faced with modifying the thickness of the tissue patch of Koob would have a reasonable expectation of success in making such a modification based on the desired medical application and/or surgical need and procedure; and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed ranges solves any stated problem, indicating that the elasticity is based on the tissue being treated (see specification as originally filed paragraph [0030] “tissue repair patch should also have a thickness suitable for the type of tissue where it is being used”) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to modify the modulus of elasticity of Koob to have a thickness ranging from 0.1 mm to 3 mm as an obvious matter of design choice within the skill in the art based on the desired medical application and/or surgical need and procedure.
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Koob, as applied to claims 1 and 14 above, in view of Akkus et al. (US 2021/0228771 A1) (Akkus).
Referring to claims 13 and 19: Koob teaches micronized collagen and placental components, which can include chorion, compressed into a mold to form a desired shape (see paragraphs [0018], [0077] and [0092]). Koob is silent to the structural component comprises electrocompacted collagen and chorion. Akkus teaches a biological material formed by electrochemical compaction (see paragraph [0119]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koob to compress the micronized composition through electrochemical compaction like taught by Akkus in order to improve the mechanical properties of the tissue patch (see Akkus paragraph [0119]).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Koob in view of Qin et al. (US 2018/0361026 A1) (Qin).
Referring to claim 21: As applied to claim 14 above, Koob provides multiple examples of wound treatment (see paragraphs [0041], [0095]-[0098] and [0105]-[0106]; wherein it is clear that the patch is adhered to the tissue wound or defect in order to promote wound or defect healing) but is silent the tissue wound or defect is a bladder wound or defect. Qin teaches a placenta-derived graft (see abstract) and a method of repairing a defect in or on a tissue comprising covering or contacting the site of the defect with the placenta-derived graft, wherein the defect may be in the bladder or vagina (see paragraph [0088]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Koob with providing treatment of a tissue wound or defect of the bladder like taught by Qin in order to yield predictable results in aid in enhancing or improving wound healing (see Qin paragraph [0088]).
Referring to claim 22: As applied to claim 20 above, Koob provides multiple examples of wound treatment including obstetrics and gynecological treatments (see paragraphs [0041], [0095]-[0098] and [0105]-[0106]; wherein it is clear that the patch is adhered to the tissue wound or defect in order to promote wound or defect healing) but is silent the genitourinary tissue wound or defect is an obstetric-related vesico-vaginal fistula. Qin teaches a placenta-derived graft (see abstract) and a method of repairing a defect in or on a tissue comprising covering or contacting the site of the defect with the placenta-derived graft, wherein the defect may be in the bladder or vagina (see paragraph [0088]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Koob with providing treatment of a tissue wound or defect of the vagina like taught by Qin including a vesico-vaginal fistula in order to yield predictable results in aid in enhancing or improving wound healing (see Qin paragraph [0088]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE R WILSON whose telephone number is (571)270-7517. The examiner can normally be reached Monday thru Friday 8 AM-5:00 PM ET.
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/KAYLEE R WILSON/Primary Examiner, Art Unit 3700