DETAILED ACTION
Status of the Claims
Claims 5-21 are pending in the instant application. Claims 13-20 have been withdrawn based upon Restriction/Election as discussed below. Claims 5-12 and 21 are being examined on the merits in the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/18/2026 has been entered.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The instant Application is the U.S. entry (371) of PCT/US2021/013464 filed 01/14/2021. And claims priority to U.S. Provisional Application 62/961,138 filed 01/14/2020.
The U.S. effective filing date for claims 5-8 has been determined to be 01/14/2020, the filing date of 62/961,138. The U.S. effective filing date for claims 9-12 and 21 has been determined to be 01/14/2021, the filing date of PCT/US2021/013464. The examiner finds no support for a third component, as recited in claims 9-12, in 62/961,138.
Restriction/Election
The examiner required an election of species of (a) A species of two or more components, each with specificity to (i) a tissue matrix and (ii) a tissue type; and (b) one or more additional materials, with specificity to each material (Restriction/Election dated 02/24/2025, p. 4). In response Applicant elected (a) TWO components and: for FIRST component: (i) GRANULES, and (ii) BONE, and for SECOND component (i) FIBERS, and CARTILAGE; and (b) ONE “additional material” and: (i) extracellular matrix biomaterials.
The examiner hereby withdraws the election of (a)(i) a tissue matrix, and maintains the species election for (a)(ii) tissue matrix which is a FIRST component that is BONE, and a SECOND component that is CARTILAGE, and b) ONE “additional material” and: (i) extracellular matrix biomaterials.
The Restriction between Group I drawn to compositions of matter and Group II methods of making/using is maintained.
Claim Objections – Rule 1.121
Claim 5 has been amended to recite “wherein the at least one particulate physical form of the first component and the at least one particulate physical form of the second component are each selected from pieces, granules, particles, powder, fibers, and putty, and may be the same or different. The bolded text not underlined is newly presented, an not compliant with 37 C.F.R. 1.121(c)(2).
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 5-8 and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by MCKAY (US 2006/0247790; published November, 2006).
Applicants Claims
Applicant claims a multiple component graft for treating a tissue defect, comprising two or more components, each of which comprises a tissue-derived matrix or a multiple tissue matrix, wherein at least two of the components are derived from and comprise different types of tissue, wherein the two or more components comprise at least:
a first component which comprises a first tissue-derived matrix or a first multiple tissue matrix which includes at least a first type of tissue and, prior to and during implantation, at least one particulate physical form, and
a second component which comprises a second tissue-derived matrix or a second multiple tissue matrix which includes at least a second type of tissue which is different from the first type of tissue and, prior to and during implantation, at least one particulate physical form,
wherein the at least one particulate physical form of the first component and the at least one particulate physical form of the second component are selected from pieces, granules, particles, powder, fibers, and putty, and may be the same or different from one another (instant claim 5).
Elected Species: Applicants have elected the following species in the reply filed 04/22/2025: (a) a species of two or more components, each with specificity to (i) a tissue matrix and (ii) a tissue type is a first component (ii) bone; and a second component (ii) cartilage. And (b) one or more additional materials, with specificity to each material is (i) extracellular matrix biomaterials.
Claim interpretation: Instant claim 5 recites the transitional phrase “comprising” in lines 1, “comprises” in lines 2-5 and 8. MPEP §2111 makes clear that: “During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification."” MPEP §2111.03 makes clear that: “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Claim 5 is recited above, and requires a first tissue-derived matrix (bone) and a second tissue-derived matrix (cartilage) which is “prior to and during implantation, at least one particulate physical form” selected from “pieces, granules, particles, powder, fibers and putty”. The examiner is interpreting the claims as open-ended not excluding unrecited elements such as a monolithic tissue structure. Additionally, the claims do not limit the amount of “a first component” or “a second component” such that any amount reads on the claims.
Disclosure of the Prior Art
MCKAY discloses shaped osteochondral grafts and methods of using the same (title), and particularly "Described are plug grafts and in particular embodiments osteochondral plug grafts and grafting methods which utilize unique plug geometries and cooperative graft/host tissue interfaces to improve stability of grafted plugs within host tissue. Embodiments of the invention include harvested osteochondral or synthetic plug grafts having bore geometries other than circular cylinders and which are implantable in correspondingly prepared host sites to resist rotation and improve stability." (Abstract, see whole document). MCKAY discloses that: "Osteochondral grafts of the invention can be used in the repair of articular cartilage in patients, including for example that occurring in weight bearing joints such as those noted above and especially in the knee. The articular cartilage in need of repair can, for example, present a full thickness defect, including damage to both the cartilage and the underlying subchondral bone. Such defects can occur due to trauma or due to advanced stages of diseases, including arthritic diseases." ([0038]).
MCKAY discloses that: "With reference now to FIGS. 4 and 5, shown are top and perspective views, respectively, of another multi-lobed osteochondral graft of the present invention. Graft 50 also includes a cartilage layer 52 attached to an underlying bone body 54." [emphasis added]([0041 ]). The Graft 50 includes a first tissue matrix which is a cartilage layer (52), and a second tissue matrix which is bone tissue (54) which are regarded as different tissue types (instant claim 2, line 2).
MCKAY discloses that: “The inventive osteochondral graft includes an osteochondral plug graft having a cartilage cap and a body of bone attached to the cartilage cap. The body of bone includes a stabilizing portion for receipt within the surgical opening, wherein the stabilizing portion of the bone body presents an external three-dimensional contour other than a circular cylinder. The stabilizing portion is further configured for mated receipt within the surgical opening to provide a mechanical interlock against rotation. In certain embodiments, osteochondral graft plugs include a body of bone having a cross-sectional profile that is non-circular but includes at least a portion defining an arc of a circle. Illustratively, such osteochondral graft plugs can take the form of multi-lobed grafts, wherein each lobe has a cross-sectional profile forming an arc of a circle. Such grafts may have two, three, four, or more such lobes. In further embodiments, osteochondral graft plugs of the invention can have bone bodies with polygonal cross-sectional profiles such as triangular, rectangular (including square), heptagonal, hexagonal, etc. cross-sectional profiles. Such grafts, or synthetic grafts having similar features, can for example be implanted into surgically prepared openings of similar shape to provide implanted grafts locked against rotation. As well, embodiments of the invention provide grafts including a bone body having an ovate cross-sectional profile, which can be implanted in openings of similar shape.” ([0009])(instant claim 3-4, three-dimensional shape).
MCKAY discloses that: “In this regard, such grafts may have a uniform composition throughout, or may vary, for instance having a plug body formed of a first, relatively strong and loadbearing material (e.g. a ceramic, polymer or composite), and a cap formed of another material to provide the articulating surface formed by another material, for example a relatively smooth polymer layer. These and other variants will be apparent to the skilled artisan from the descriptions herein.” ([0051])(instant claims 5-6).
MCKAY discloses that: “Growth factor may be applied to the tissue source in the form of a buffered aqueous solution. Other materials which may be suitable for use in application of the growth factors in the methods and products of the present invention include carrier materials such as collagen, milled cartilage, hyaluronic acid, […]” ([0055]). And that: “Other biologically active materials may also be used in conjunction with osteochondral grafts of the present invention. These include for example cells such as human allogenic or autologous chondrocytes, human allogenic cells, human allogenic or autologous bone marrow cells, human allogenic or autologous stem cells, […].” ([0056])(instant claim 7).
MCKAY discloses that: “When used, the growth factor and/or other material(s) can be applied directly to the plug graft and/or to the site in need of repair. For example, the growth factor and/or other material may be physically applied to the graft (e.g. the bone and/or cartilage tissue of an osteochondral graft) through spraying or dipping, or using a brush or other suitable applicator, such as a syringe. Alternatively, or in addition, amounts of the growth factor or other material(s) can be directly applied to the site in need of tissue repair, for example by filling or coating the surgically-prepared opening with one or more of these substances.” ([0058])(instant claim 8).
Regarding the limitation “prior to and during implantation’ at least one particulate physical form, wherein the at least one particulate physical form of the first component […] and the second component are each selected from pieces, granules, particles, powder, fibers and putty” (instant claim 5, lines 10-13), the examiner argues that the osteochondral grafts described by MCKAY would have included at least a small portion of surface particles such as minute bone and cartilage fragments in particulate form as the process of harvesting an allograft plug is destructive to the tissue (see MCKAY [0034] to [0039]). The instantly rejected claims being open to any amount of particulate particles of bone and cartilage, the osteochondral implants of MCKAY would have inherently included at least a small portion of surface particles such as minute bone and cartilage fragments in particulate form as the process of harvesting an allograft plug is destructive to the tissue (MPEP §2112(IV)).
Response to Arguments:
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive.
Applicant argues that: “Thus, first, second, and third components which have non-particulate forms, such as monolithic and pre-formed three dimensional shapes, prior to and during implantation, are now more clearly excluded from the scope of each of amended Claims 5 and 10, as well as from Claims 6-9, 21, and 11-12, each of which depends variously from either Claim 5 or 10.” (p. 7, 1st paragraph).
In response the examiner argues that nothing is excluded from the scope of the of the amended claims, as the claims are drafted with open-ended claim language. Particularly, instant claim 5 recites the transitional phrase “comprising” in lines 1, “comprises” in lines 2-5 and 8. MPEP §2111 makes clear that: “During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification."” MPEP §2111.03 makes clear that: “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Claim 5 is recited above, and requires a first tissue-derived matrix (bone) and a second tissue-derived matrix (cartilage) which is “prior to and during implantation, at least one particulate physical form” selected from “pieces, granules, particles, powder, fibers and putty”. The examiner is interpreting the claims as open-ended not excluding unrecited elements such as a monolithic tissue structure. Additionally, the claims do not limit the amount of “a first component” or “a second component” such that any amount reads on the claims.
Applicant further argues that: “Applicant also notes the previous deletion of original Claim 3, which included "three-dimensional shapes" among the possible physical forms, as well as the previous deletion of original Claim 4, which recited that the "three-dimensional shapes are selected from: monolithic, multipiece, shapes otherwise formed, molded or shaped from other physical forms, and combinations thereof. Deletion of Claims 3 and 4 further evidences exclusion of such non-particulate, i.e., monolithic and formed, molded, or shaped three-dimensional shapes from possible physical forms for the components of the claimed graft according to any of pending Claims 5-21.” (p. 8, 2nd paragraph).
In response the examiner agues that the claims are open-ended and encompass any amount of particulate bone and cartilage, as discussed above. The claims clearly do not exclude monolithic pieces with any amount of surface particles thereon. The examiner notes NASERT (US 2017/0049930 A1) by the same Applicant, includes Glossary of terms ([0163] through [0233] defining terms in the art to which the invention pertains including – “The term "particle" as used herein refers to a chip, fragment, slice, fiber or other small constituent of a larger body (e.g., picoparticles, nanoparticles, microparticles, milliparticle, centiparticle, deciparticle; fractions thereof, or, in some instances, a larger segment or piece).” And – “The term "piece" as used herein refers to a particle, section, strip, chip, fragment, slice, fiber or other part, derived from, cut off, or broken from a larger unit.” The monolithic bone/cartilage plug being within the scope of what Applicant regards as “pieces”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 5-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over TRUNCALE (US 2005/0251268; published November, 2005) in view of KOOB (US 2016/0199537; published July, 2016).
Applicants Claims
Applicant claims a multiple component graft for treating a tissue defect, comprising two or more components, each of which comprises a tissue-derived matrix or a multiple tissue matrix, wherein at least two of the components are derived from and comprise different types of tissue, wherein the two or more components comprise at least:
a first component which comprises a first tissue-derived matrix or a first multiple tissue matrix which includes at least a first type of tissue and, prior to and during implantation, at least one particulate physical form, and
a second component which comprises a second tissue-derived matrix or a second multiple tissue matrix which includes at least a second type of tissue which is different from the first type of tissue and, prior to and during implantation, at least one particulate physical form,
wherein the at least one particulate physical form of the first component and the at least one particulate physical form of the second component are selected from pieces, granules, particles, powder, fibers, and putty, and may be the same or different from one another (instant claim 5).
Elected Species: Applicants have elected the following species in the reply filed 04/22/2025: (a) a species of two or more components, each with specificity to (i) a tissue matrix and (ii) a tissue type is a first component (ii) bone; and a second component (ii) cartilage. And (b) one or more additional materials, with specificity to each material is (i) extracellular matrix biomaterials.
Claim interpretation: Interpretation of the instant claims is discussed above and incorporated herein by reference.
Determination of the scope
and content of the prior art (MPEP 2141.01)
TRUNCALE teaches “A cartilage allograft construct assembly comprising a plug with a subchondral bone base and a smaller cross sectional cartilage cap for repairing articular cartilage defects is used together with a milled cartilage in a biocompatible carrier forming a paste or gel which is added to the plug or placed in a channel formed between the cartilage cap and a wall of a bore which has been cut into the patient to remove the lesion defect area. Additives may be applied to the cartilage mixture in order to increase chondrocyte migration and proliferation.” [emphasis added]([0024]). And that: “It is an object of the invention to provide an allograft implant for joints which provides pain relief, restores normal function and will postpone or alleviate the need for prosthetic replacement.” ([0025]). And further that: “It is also an object of the invention to provide a cartilage repair implant which is easily placed in a defect area by the surgeon using an arthroscopic, minimally invasive technique.” ([0026]). And further that: “It is yet another object of the invention to provide an allograft implant which facilitates growth of hyaline cartilage.” ([0029]). And further that: “It is an additional object of the invention to provide implant plugs together with paste and gel formulations that satisfy surgical requirements and are made from available allograft tissue, some of which would otherwise be considered waste and thrown away.” ([0030]).
TRUNCALE further teaches that: “a ring shaped channel 50 with an inclined bottom surface defined by tapered surface 46 is formed when the plug 40 is inserted in the bore 60 to receive the milled or minced allograft cartilage biological carrier mixture and additives. This channel has the same range of widths as previously” ([0045]). And that: “In operation the lesion or defect is removed by cutting a cylindrical bore 60 removing a lesion in the implant area 100 and filling the channel 50 and optionally a portion of the bore 60 or cut away area with a desired amount of a milled allograft cartilage mixture and a biological carrier such as sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran, or polymers.” ([0046])(instant claim 8). TRUNCALE teaches that: “If desired demineralized or partially demineralized bone powder having a size range from 200 to 850 microns with a weight ranging from 1 % to 35% of the cartilage mixture can be added to the milled cartilage glue mixture 30.” ([0047])(instant claim 5, a first component is bone – “demineralized bone powder”; and a second component is cartilage – “milled cartilage”; instant claims 6 & 21).
Regarding instant claim 7, the one or more additional materials being “extracellular matrix biomaterials” (elected species), the instant Specification discloses that: “extracellular matrix biomaterials, such as collagen, or natural- or animal-derived biomaterials, such as chitosan or alginate, bone marrow, bone marrow concentrate, blood-derived products, platelet-rich plasma (PRP), platelet-poor plasma (PPP), exogenous cells, or combinations thereof.” (instant Specification p. 9, [0027]). TRUNCALE clearly teaches the inclusion of “a milled allograft cartilage mixture and a biological carrier such as sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran, or polymers.” ([0046]). Additionally, TRUNCALE teaches that “Articular cartilage (hyaline cartilage) consists primarily of extracellular matrix with a sparse population of chondrocytes distributed throughout the tissue.” ([0004]), and suggests the “The plug and minced hyaline cartilage can be stored frozen or freeze dried and support any of the mentioned chondrogenic stimulating factors.” [emphasis added]([0049])(instant claim 7).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of TRUNCALE is that TRUNCALE does not expressly teach the inclusion of amnion-derived tissue (instant claims 9-10).
KOOB teaches collagen reinforced tissue grafts (title), and particularly that: “This invention is directed to a multi-layered tissue graft comprising a collagen layer and at least one separated and washed placental tissue component and/or umbilical cord component, wherein the collagen is human collagen substantially free of non-human antigens.” (abstract, see whole document).
KOOB teaches that: “Because the collagen derives from immune-privileged human tissue, the disclosed tissue grafts do not illicit an unwanted immune response in the subject that would require medical treatment for the immune response. By contrast, reconstituted collagen from human cadaveric donors, i.e., allografts, and nonhuman species, termed xenografts, present a greater challenge for in vivo use with respect to antigenicity and induction of a foreign body response.” [emphasis added]([0007]).
KOOB teaches that: “The term ‘amnion’ as used herein includes amniotic membrane where the intermediate tissue layer is intact or has been substantially removed.” And further: “The term ‘placental tissue’ refers to any and all of the well-known components of the placenta including but not limited to amnion, chorion, and the like, and including processed tissue, such as dehydrated placental tissue and micronized placental tissue. The term ‘placental tissue’ as used herein does not include any of the umbilical cord components(e.g., Wharton's jelly, umbilical cord vein and artery, and surrounding membrane).” ([0018]). And that: “‘Collagen,’ as used herein, refers to biocompatible collagen derived from immune-privileged human tissue, such as placental tissue or an umbilical cord. The collagen, once obtained from human immune-privileged human tissue, may be in any form, such as a gel, gelatin, fibril, slurry, hydrogel or a film. It should be noted that the fibrous layer of amnion (i.e., the basement membrane) contains collagen types IV, V, and VII.” ([0019]).
KOOB teaches that: “In some embodiments, the multi-layered tissue graft includes from 1 to 10 wt%, 10 to 20 wt%, 20 to 30 wt%, 30 to 40 wt %, 40 to 50 wt %, 50 to 60 wt %, 60 to 70 wt %, 70 to 80 wt% amnion relative to the total weight of the multilayered tissue graft.” ([0048]).
KOOB teaches that: “In some embodiments, the fibroblast layer of the amnion
layer(s) acts as an adhesive for the next layer.” ([0059]). And that: “The designation "amnion/collagen/amnion," for example, means that a layer of collagen is interposed between two layers of amnion. It is important to note that when multiple amnion layers are used, it is not necessary to partially remove the epithelial cells from the basement membrane for those layers that are not in direct contact with host cells.” ([0061]).
KOOB teaches that: “In one aspect, the grafts or micronized pharmaceutical compositions described herein are useful in enhancing or improving wound healing.” ([0095])(instant claim 9-10, “the third tissue type is amnion” “particulate physical form”).
KOOB teaches that: “In another aspect, the tissue grafts or micronized pharmaceutical compositions can be used in the treatment of bone defects and bone repair.” ([0113]). And that: “Amnion contains growth factors such as EGF, bFGF, and PDGF that promote wound healing and re-epithelialization. Not wishing to be bound by theory, the application of a topical composition composed of the tissue grafts or micronized compositions described herein where the epithelial layer of the skin is disrupted can be effective in delivering the growth factors directly to the injured site to promote healing. Amnion is a unique ECM due to the presence of collagen types IV, V and VII, which enables the amnion to bind water and swell.” ([0119]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a multiple component allograft osteochondral plug including a cartilage portion and a bone, as well as a cartilage glue/gel/paste mixture including minced/milled hyaline cartilage incorporating demineralized bone powder, as taught by TRUNCALE, and further to include collagen in the cartilage glue/gel/paste mixture, as suggested by TRUNCALE, the collagen including amnion to reduce any unwanted immune response and to enhancing or improving wound healing, as suggested by KOOB.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary skill in the art to produce a osteochondral graft as taught by TRUNCALE including a cartilage glue/gel/paste mixture including bone particles and amnion/cartilage particles, as taught by KOOB. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Response to Arguments:
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive.
Applicants arguments over MCKAY and RICHARDSON are acknowledged, however these references are no longer relied upon for the obviousness rejection, and are therefore moot.
Conclusion
Claims 5-12 and 21 are pending and have been examined on the merits. Claims 5-8 and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2); and claims 5-12 and 21 are rejected under 35 U.S.C. 103. No claims allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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