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 . Claims 60-79 are pending and examined below.
Election/Restrictions
Claims 60-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/20/2025.
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.
Claims 63-79 are 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 63, the phrase "implant material" renders the claim indefinite because it is unclear what type of “material” is required to be considered an “implant material”. The dependent claims are likewise rejected.
Regarding claim 63, the phrase " wherein the tissue graft is cultured with an implant material to promote attachment of the cells to the implant material” renders the claim indefinite because it is unclear if the tissue graft is removed from the scaffold, then cultured with the implant material or if the tissue graft is still attached to the scaffold, then cultured in combination with the implant material. The dependent claims are likewise rejected.
Claims 63 and 70-73 recite the limitation "the cells" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 78, the phrase "mechanized tool" renders the claim indefinite because it is unclear what requirements are needed for a tool to be considered a “mechanized tool”. The dependent claims are likewise rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 74 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 74 recites, “the method comprising attaching the tissue graft to the implant material”; however the independent claim 63, recites “the tissue graft is cultured with an implant material to promote attachment of the cells to the implant material”, which means the tissue graft will be attached to the implant material. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. The dependent claims are likewise rejected.
Claim Rejections - 35 USC § 102
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.
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 63-79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin et al (US 2011/0159070 A1).
Regarding claim 63, Jin et al discloses a method of preparing a hybrid bone-implant graft (a bone implant capable of having both bone and cartilage growth, paragraph 0066 and 0077), the method comprising culturing one or more populations of cells on a scaffold to form a tissue graft (chondrocytes, marrow stromal cells, totipotent cells, paragraphs 0073-0075), wherein the tissue graft is cultured with an implant material to promote attachment of the cells to the implant material (Fig. 5: alloy base, paragraph 0167) .
Regarding claim 64. The method of claim 63, Jin et al discloses wherein the tissue graft is a bone graft (bone growth, paragraph 0082).
Regarding claim 65. The method of claim 63, Jin et al discloses wherein the tissue graft is a cartilage graft (cartilage growth, paragraph 0082).
Regarding claim 66, et al discloses the method of claim 63, Jin et al discloses wherein the tissue graft is vascularized (the tissue graft would become vascularized due to addition of the vascular endothelial growth factors, paragraphs 0106-0108).
Regarding claim 67, Jin et al discloses the method of claim 63, wherein the tissue graft has a thickness of about one centimeter or less (paragraph 0016).
Regarding claim 68, Jin et al discloses the method of claim 63, wherein the tissue graft has a thickness of from about 0.3 millimeters to about 10 millimeters (paragraph 0016).
Regarding claim 69, Jin et al discloses the method of claim 63, wherein the scaffold is generated using computer assisted manufacturing, three-dimensional printing, casting (paragraph 0194), milling, laser cutting, rapid prototyping, or any combination thereof.
Regarding claim 70, Jin et al discloses the method of claim 63, wherein the cells are derived from induced pluripotent stem cells (paragraph 0200).
Regarding claim 71, Jin et al discloses the method of claim 63, wherein the cells comprise bone-forming cells and/or cells capable of differentiating into bone-forming cells (paragraphs 0041-0042).
Regarding claim 72, Jin et al discloses the method of claim 63, wherein the cells comprise blood vessel- forming cells and/or cells capable of differentiating into blood vessel-forming cells (paragraphs 0041 and 0073).
Regarding claim 7, Jin et al discloses the method of claim 63, wherein the cells comprise endothelial progenitor cells (paragraph 0080).
Regarding claim 74, Jin et al discloses a method of forming the hybrid bone-implant graft of claim 63, the method comprising attaching the tissue graft to the implant material (Fig. 5: paragraphs 0068 and 0119).
Regarding claim 75, Jin et al discloses the method of claim 74, wherein the tissue graft is seeded with cells before attachment to the implant material (paragraph 0050).
Regarding claim 76, Jin et al discloses the method of claim 74, wherein the tissue graft is seeded with cells after attachment to the implant material (paragraph 0050). .
Regarding claim 77, Jin et al discloses the method of claim 74, wherein the implant material and tissue graft are threadably attached (paragraph 0068).
Regarding claim 78, Jin et al discloses the method of claim 74, wherein the implant material and tissue graft are manually attached or attached via a mechanized tool (paragraph 0068).
Regarding claim 79, Jin et al discloses the method of claim 74, wherein the implant material and tissue graft are attached by boring a hole into the tissue graft and inserting the implant material into the hole (Fig. 5, paragraph 0119).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.T./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774