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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-11, in the reply filed on 14 January 2026, is acknowledged. The traversal is on the ground(s) that the invention will be considered to have unity of invention if the claims are drawn to particular combinations of categories. Applicant contends that Groups I and II and groups I and III are each related as a product and a process specially adapted for the manufacture of said product, and that groups II and III are related as combination sub-combination. This is not found persuasive because combination/sub-combination is not used in requirements for unity of invention. The groups are not so linked as to form a single general inventive concept because they lack the same or corresponding special technical feature. The technical feature required by the groups is a cut tissue graft. The limitation “cutting the donor tissue with a fluid formed of a physiological buffered solution to maintain the native matrix and/or viability of the tissue at the modified surface” is not required by claim 1. The limitations in claim 1 regarding the fluid cutting process are treated as a product by process limitation.
Assuming arguendo, the technical feature of the cutting with a fluid formed of a physiological buffered solution is not a special technical feature in view of U.S. Patent Application Publication No. US 2020/0291068 to Alvarez which discloses cutting with a saw lubricated with cooled phosphate buffered saline (par. [0340]) (citation below).
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 January 2026.
Priority
The priority date is 19 January 2022.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification fails to provide proper antecedent basis for originally claimed subject matter, including but not necessarily limited to: “the tissue maintains a native structure and/or viability at the boundary surface” (emphasis added) (claim 1); “the graft is in a cylindrical, oblong, rectangular, core, particulate, or irregular form” (claim 2); “the tissue matrix is in particulate form with maintained tissue viability and/or native architecture particulate and is mixed with hydrogels, synthetic or natural materials, polymers, to form the tissue matrix” (claim 3); “tissue sourced from a recipient or patient with the tissue defect” (claim 4); “autologous tissue” (claim 5); “the tissue is osteochondral tissue with a cartilaginous layer and a bone portion, wherein a boundary of the graft maintains a native matrix and/or viability of the tissue through use of a fluid cutting process” (emphasis added) (claim 6); “the bone portion includes a rounded or angled surface edge to aide in implantation” (claim 7); “the cartilaginous layer has a thickness of at least 0.050 mm and wherein the bone portion has a thickness of at least 0.010 mm” (claim 8); “the cutting process further employs a particulate abrasive additive involving biocompatible materials” (claim 9); “the tissue matrix includes conduits, pores, cuts, or a modified surface architecture or topology to improve integration” (claim 11). Original claim language can be imported into the specification.
The disclosure is objected to because of the following informalities: As to claim 9, in particular, the specification is silent as to the cutting process further employs a particulate abrasive additive involving biocompatible materials (claim 9), in addition to the cutting process employing a fluid formed of a physiological buffered solution (claim 1). The use of a particulate abrasive additive is described in par. [0018], which goes on to recite that “In another embodiment” the system uses physiological buffered solutions. Although par. [0024] recites that hyperosmotic solution can be used to prevent dissolving of additive crystals (the abrasive media), the hyperosmotic solution is listed in the alternative to physiological buffered solutions. Appropriate correction is required.
Claim Objections
Claims 3 and 5-10 are objected to because of the following informalities: improper antecedence and grammar. Appropriate correction is required. The following corrections are suggested:
Claim 3 / line 3: “materials, or polymers,”
Claim 5 / line 2: “adipose,
Claim 6 / lines 2-3: “wherein [[a]] the boundary surface of the graft maintains [[a]] the native structure and/or viability of the tissue through use of [[a]] the fluid cutting”
Claim 9 / line 2: “materials.”
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, 2, and 4-11 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2008/0160496 to Rzepakovsky et al. (hereinafter, “Rzepakovsky”).
As to claim 1, Rzepakovsky discloses a customized tissue graft (customized to a desired size, par. [0132], [0134]) for repair of a tissue defect, said tissue graft comprising: a tissue matrix (par. [0013], [0026]) having tissue with a boundary surface (boundary of the graft), FIG. 1, formed through a fluid cutting process, wherein the cutting process employs a fluid formed of a physiological buffered solution and the tissue maintains a native structure and/or viability at the boundary surface (the tissue maintains viability at the boundary surface because there is viability in all areas of the cartilage portion which means there is viability at the boundary surface, par. [0028]). The claimed phrase “formed through a fluid cutting process, wherein the cutting process employs a fluid formed of a physiological buffered solution and the tissue maintains a native structure and/or viability at the boundary surface” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Since Rzepakovsky’s tissue graft tissue maintains viability at the boundary surface, it is substantially the same as the claimed product.
As to claim 2, Rzepakovsky discloses the tissue graft of claim 1, wherein the graft is in a cylindrical (par. [0111]), FIG. 1, oblong, rectangular, core, particulate, or irregular form.
As to claim 4, Rzepakovsky discloses the tissue graft of claim 1, wherein the tissue comprises soft and/or hard tissue (par. [0111]) sourced from a recipient or patient with the tissue defect or from donors (par. [0111]).
As to claim 5, Rzepakovsky discloses the tissue graft of claim 4, wherein the tissue comprises musculoskeletal, neural, dermal, cardiovascular, ocular, nasal, costal, adipose, systems, or any tissue or organ type of a donor (par. [0111]) or autologous tissue.
As to claim 6, Rzepakovsky discloses the tissue graft of claim 1, wherein the tissue is osteochondral tissue with a cartilaginous layer (15) and a bone portion (12) (par. [0111]), FIG. 1, wherein a boundary of the graft maintains a native matrix and/or viability of the tissue (the tissue maintains viability at the boundary of the graft because there is viability in all areas of the cartilage portion which means there is viability at the boundary surface, par. [0028]) through use of a fluid cutting process. The claimed phrase “through use of a fluid cutting process” is being treated as a product by process limitation, as above.
As to claim 7, Rzepakovsky discloses the tissue graft of claim 6, wherein the bone portion includes a rounded (about the exterior of the cylindrical shape) or angled surface edge to aide in implantation (into a similarly shaped hole, for example).
As to claim 8, Rzepakovsky discloses the tissue graft of claim 6, wherein the cartilaginous layer has a thickness of at least 0.050 mm (the cartilaginous layer 15 has a thickness between about 2 mm and about 5 mm, which is at least 0.050 mm, par. [0112]) and wherein the bone portion has a thickness of at least 0.010 mm (since the bone portion 12 is thicker than the cartilaginous layer 15 as shown in FIG. 1, and the cartilaginous layer thickness is between about 2 mm and about 5 mm or at least 0.010 mm, then the bone portion, being thicker than the cartilaginous layer, is also at least 0.010 mm thick).
As to claim 9, Rzepakovsky discloses the tissue graft of claim 1 wherein the cutting process further employs a particulate abrasive additive involving biocompatible materials. The claimed phrase “the cutting process further employs a particulate abrasive additive involving biocompatible materials” is being treated as a product by process limitation, as above. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Since Rzepakovsky’s tissue graft tissue maintains viability at the boundary surface, it is substantially the same as the claimed product.
As to claim 10, Rzepakovsky discloses the tissue graft of claim 6, wherein the bone portion contains additional tissue removal (via cuts 18A-18F, par. [0114]; and/or removal of tissue components, par. [0052]), FIGS. 2A-2F, to allow shape manipulation (interpreted as language of intended use; the additional tissue removal is fully capable of allowing shape manipulation, because the cuts would allow greater flexibility where they are located, and the cuts themselves manipulate or change the overall shape of the graft particularly at the surface in which the cuts are made).
As to claim 11, Rzepakovsky discloses the tissue graft of claim 1, wherein the tissue matrix includes conduits, pores, cuts (18A-18F) (par. [0114]), FIGS. 2A-2F, or a modified surface architecture or topology to improve integration.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rzepakovsky in view of WIPO International Publication No. WO 2021/146442 to Long et al. (hereinafter, “Long”).
As to claim 3, Rzepakovsky is silent as to wherein the tissue matrix is in particulate form with maintained tissue viability and/or native architecture particulate and is mixed with hydrogels, synthetic or natural materials, polymers, to form the tissue matrix.
Long teaches that a tissue graft comprises a tissue matrix comprising multiple parts, such as a monolithic or multi-piece physical form with a particulate (powder or granules) mixed with a biocompatible gel carrier (which is either synthetic or natural) applied to or layered on the monolithic or multi-piece matrix (par. [0051]; page 21 / lines 2-7).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise Rzepakovsky’s tissue matrix of multiple parts, by including an application or layer of particulate mixed with a biocompatible gel carrier (which is either synthetic or natural), as taught by Long, into or onto the physical form of the tissue matrix disclosed in Rzepakovsky, in order to more effectively treat multiple tissue defects with a multiple component graft, as taught by Long. Since Rzepakovsky discloses that the tissue matrix has maintained tissue viability, then the multiple part tissue matrix as modified in view of Long would still have maintained tissue viability since it includes a layer of the matrix as disclosed in Rzepakovsky which has maintained tissue viability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. US 2020/0291068 to Alvarez discloses cutting with a saw lubricated with cooled phosphate buffered saline (par. [0340]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775