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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 13 July 2026. As directed by the amendment: claims 3, 5-7, and 9 are amended, and claims 12-20 stand withdrawn. Claims 1-20 currently stand pending in the application.
The amendments to the specification are sufficient to overcome the previous specification objections, and the specification amendments are entered. However, a further specification objection is presented below as necessitated by the specification amendments, as discussed below.
The amendments to the claims are sufficient to overcome the previous claim objections, which are correspondingly withdrawn.
Response to Arguments
Applicant's arguments filed 13 July 2026 have been fully considered but they are not persuasive. As to the specification objection regarding claim 9, Applicant has amended the specification to recite “The fluid cutting process can employ both a physiological buffered solution and a particulate abrasive additive simultaneously” (par. [0020]), and points to paragraph [0024] of the specification for support for use of both a physiological buffered solution and a particulate abrasive additive in the fluid cutting process. Examiner respectfully submits that paragraph [0024] of the specification recites that the water cutting system may or may not include abrasive media to support cutting. In another embodiment, the water cutter system can use physiological buffered solutions such as phosphate buffered saline or solutions of controlled osmolarity (e.g., hyperosmotic solution). In another embodiment, the hyperosmotic solution can be used to prevent dissolving of the additive crystals to enhance their cutting abilities. The physiological buffered solution and particulate abrasive additive therefore appear to be disclosed in different embodiments, since the water cutting system may use abrasive media, while in another embodiment the water cutting system can use physiological buffered solutions such as phosphate buffered saline or solutions of controlled osmolarity (e.g., hyperosmotic solution). The hyperosmotic solution can be used to prevent dissolving of the additive crystals to enhance their cutting abilities. The specification does not recite that the physiological buffered solutions, which is the alternative to the hyperosmotic solution, is used simultaneously with the particulate abrasive additive.
Applicant's arguments as to the rejections 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”), have been fully considered but they are not persuasive. Applicant contends that the claimed tissue graft maintains a native structure and/or viability specifically at the boundary surface as a direct result of the fluid cutting process employing a physiological buffered solution. This structural characteristic – the maintenance of native structure and/or viability at the boundary surface – is not merely a functional recitation but reflects a distinct structural property of the tissue at the cut surface that is not disclosed by Rzepakovsky. Applicant contends that Rzepakovsky does not disclose maintenance of native structure and/or viability at the boundary surface. Applicant contends that the mere fact that Rzepakovsky discloses viability in the cartilage portion does not establish that the boundary surface maintains native structure and/or viability. Examiner respectfully submits that the tissue maintaining a native structure and/or viability at the boundary surface is not recited in the claims as a direct result of the fluid cutting process employing a physiological buffered solution. Claim 1 recites that the boundary surface is formed through a fluid cutting process employing a fluid formed of a physiological buffered solution, and the tissue maintains a native structure and/or viability at the boundary surface. The native structure and/or viability at the boundary surface is not recited as direct result of the fluid cutting process employing a physiological buffered solution. The limitation that the tissue maintains a native structure and/or viability at the boundary surface may be met by either native structure or viability. The term native structure is broad and may be interpreted as native to the patient or a human, which is met by Rzepakovsky. The term viability does not require 100% viability, so as long as some of the cells at the boundary surface are viable, there is viability at the boundary surface, which is met by Rzepakovsky, which does not disclose 100% cell death at the boundary surface. Rzepakovsky discloses that if 10% of cells are viable, the tissue is deemed viable (par. [0028]). A native structure and/or viability at the boundary surface may be facing inward from the boundary surface/at the interior of the boundary surface, i.e. the claim does not require viable cells completely covering an external outward facing surface of the tissue matrix. Rzepakovsky teaches viable cells at least internally, i.e. facing inward from the boundary surface. The claim may also be interpreted as a tissue matrix having tissue with a boundary surface, the tissue matrix formed through a fluid cutting process. In other words, the tissue matrix is cut into a shape using a fluid cutting process, resulting in the tissue matrix being formed through the fluid cutting process, and the tissue matrix also has tissue with a boundary surface, where the tissue may comprise internal tissue with native structure and/or viability with a boundary surface that surrounds this native/viable tissue. Then, even if Rzepakovsky’s graft were to have areas of non-native or non-viable cells, they would be outside the boundary surface of the internal native/viable tissue.
Applicant contends that because Rzepakovsky uses conventional mechanical cutting techniques, Rzepakovsky’s graft would not maintain native structure and/or viability at the boundary surface. As above, the limitation that the tissue maintains a native structure and/or viability at the boundary surface may be interpreted as native structure, which is met by the tissue being native to the patient or a human, or as viability, which is met by a percentage of the cells being viable at the boundary surface. As also described above, the boundary surface may have different interpretations, as well as the tissue at the boundary surface, such that any native/viable cells at or up to the boundary surface would meet the claim.
Applicant contends that Rzepakovsky does not establish that the boundary surface maintains native structure and/or viability, and the viability described in Rzepakovsky relates to the overall viability of the cartilage tissue, not to the specific maintenance of native structure and/or viability at the cut boundary surface. Examiner respectfully submits that a cut boundary surface is not claimed, and the boundary surface can be interpreted in different ways as discussed above. Rzepakovsky at least discloses that the tissue maintains a structure native to, i.e. from, the patient or human, at the boundary surface, in which case viability need not be met. Even if viability is considered, the claim may be interpreted such that the viability at the boundary surface may be facing inward (the boundary surface may comprise a thickness of more than a single cell), and/or the boundary surface may be a boundary of any internal native/viable tissue. The instant application does not disclose that there is 0 cell death at a boundary surface cut with a physiological buffered solution. If there is any cell death at the boundary surface, i.e. less than 100% viability, then as long as Rzepakovsky teaches some cell viability, i.e. greater than 0%, then Rzepakovsky meets the claim as much as the instant invention. In other words, the limitation that the tissue maintains viability at the boundary surface does not require 100% viability at every cell on the boundary surface.
Although U.S. Patent Application Publication No. US 2020/0291068 to Alvarez was not relied upon in the rejections under 35 U.S.C. 102(a)(1)/(2), Applicants’ arguments are addressed in the interest of compact prosecution. Applicant contends that Alvarez discloses the use of phosphate buffered saline merely as a lubricant for a saw, not as the cutting fluid itself. Examiner respectfully submits that the claims require a fluid cutting process, wherein the cutting process employs a fluid. This is met by a saw that uses phosphate buffered saline as a lubricant, since the cutting process employs a fluid. The presence of the phosphate buffered saline would help maintain the native structure and/or viability.
As to claim 7, Applicant contends that Rzepakovsky does not disclose a rounded or angled surface edge such as a chamfer or radius. Examiner respectfully submits that a chamfer or radius is not claimed. Because Rzepakovsky discloses a rounded exterior of the cylindrical shape, the edge of this shape is also rounded. Alternatively or additionally, the bottom face of the bone portion is at an angle (90 degrees) to the rounded exterior and is a surface that creates an edge with the rounded exterior. All components of the bone portion aid in implantation into a complementarily shaped hole.
As to claim 10, Applicant contends that the cuts in Rzepakovsky are made in the cartilage layer and not in the bone portion, and are not described as allowing shape manipulation of the bone portion. Examiner respectfully submits that Rzepakovsky discloses that the cuts penetrate into the bone portion (12) (par. [0112]). Any cuts result in a removal of material or structure and thus greater flexibility where they are located. This would thus allow or permit shape manipulation. The term “allow” simply means to permit. Shape manipulation is not required by the claim; rather, the tissue removal (cuts) simply must allow or permit shape manipulation, and a removal of structure creating negative space necessarily allows or permits shape manipulation into the negative space. In the arguments with respect to claim 11, Applicant also describes the cuts in Rzepakovsky allow the graft to be bent or shaped.
As to claim 11, Applicant contends that the cuts in Rzepakovsky are not described as improving integration of the graft with the surrounding tissue. Rather, the cuts in Rzepakovsky allow the graft to be bent or shaped. Examiner respectfully submits that the claim does not require integration to be with surrounding tissue. Integration could be so that the graft fits in with other parts of a kit. The cuts in Rzepakovsky would improve integration with the surrounding tissue because the surrounding tissue could grow into the cuts. Also, since Applicant recites that the cuts in Rzepakovsky are described as allowing the graft to be bent or shaped, the cuts would allow the graft to be bent or shaped into a better shape to fit into a complementary hole, therefore improving integration of the graft into the hole.
As to the rejection of claim 3 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”), Applicant contends that the claim requires the tissue matrix itself to be in particulate form with maintained tissue viability and/or native architecture, and that the particulate be mixed with hydrogels, synthetic or natural materials, or polymers to form the tissue matrix, while the rejection results in a tissue matrix comprising a multi-piece physical form with a layer of particulate mixed with a gel carrier applied to or layered on the physical form. Examiner respectfully submits that a tissue matrix comprising multiple parts, including an application or layer of particulate mixed with a biocompatible gel carrier into or onto the physical form of the tissue matrix disclosed in Rzepakovsky, meets the claimed limitation, since the tissue matrix in part comprises particulate mixed with gel/synthetic or natural material. The claim does not require the tissue matrix to consist of particulate, and could not require such a limitation since the tissue matrix is not only particulate but also mixed with other material.
Applicant contends that the particulate itself maintains tissue viability and/or native architecture. Examiner respectfully submits that this is not claimed. The claim can be read that the tissue matrix is in particulate form and the tissue matrix has maintained tissue viability and/or native architecture particulate. The multipart tissue matrix has at least a region in particulate form (taught by Long), and at least a region with maintained tissue viability (disclosed in Rzepakovsky) as discussed above. Native architecture particulate could be interpreted as native to the particulate; therefore the particulate taught in Long has its own native architecture. Examiner also submits that the claims do not require the fluid cutting process to generate the particulate.
Applicant contends that sufficient rationale for combining Rzepakovsky and Long has not been provided. Examiner respectfully submits that providing a tissue matrix comprising the physical form disclosed by Rzepakovsky as well as the particulate mixture taught by Long would allow treatment of multiple tissue defects (Long, par. [0009], [0031], [0032]) since the provision of different matrices derived from different tissues allows applicability in different tissues or regions where different tissues meet. Rzepakovsky’s tissue matrix is not being modified to be in particulate form mixed with a carrier material, but rather to have an additional layer or application onto Rzepakovsky’s tissue matrix, since Long teaches such application or layering onto a multi-piece matrix. Rzepakovsky also discloses a multi-piece or not monolithic form.
Specification
The amendment filed 13 July 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “The fluid cutting process can employ both a physiological buffered solution and a particulate abrasive additive simultaneously” (par. [0020]). Although the original claims recite a fluid formed of a physiological buffered solution (claim 1) and the cutting process further employs a particulate abrasive additive (claim 9), the claims and specification do not recite that the physiological buffered solution and the particulate abrasive additive are both employed simultaneously. 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.
Applicant is required to cancel the new matter in the reply to this Office Action.
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, 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 the boundary surface of the graft maintains the native structure 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 the 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 aid 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, or 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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