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 without traverse of Group I in the reply filed on 5/29/2026 is acknowledged. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/29/2026. The requirement is deemed proper and is therefore made FINAL.
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 9, 11-12, and their dependent claims 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. Claim 9 recites “the unseeded surface of the cell-seeded matrix.” The claims have not established that the matrix has unseeded surfaces. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 11 and 12 recite a first cannula and a third cannula, but they have not established a second cannula. As presently worded, it is unclear how may cannula instruments are required for the present invention. Appropriate correction and/or clarification is required.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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(s) 1-3, 5-8, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dadsetan et al. (WO 2006/102530 A1; hereinafter “Dadsetan”) in view of Sengun et al. (Pub. No.: US 2020/0022815 A1; hereinafter “Sengun”) further in view of Hart et al. (WO 2008/005427 A2; hereinafter “Hart”).
Dadsetan teaches the following regarding claim 1: an arthroscopic surgical method (para. 0012) comprising: making an incision in a subject adjacent to a defect to be treated arthroscopically (paras. 0012, 0068); inserting a first cannula into the first incision (para. 0068); preparing a site of the defect to be treated at a joint in the subject (para. 0068); shaping a cell-seeded matrix to match a shape of the shaped template material with the cells facing up and cutting the cell-seeded matrix to match the desired shape (paras. 0038, 0068, where the cells are on the outer surface of the matrix and will be facing up at the time of the cutting); delivering the cell-seeded matrix to the prepared defect site through the first cannula (para. 0068); and fixating the delivered cell-seeded matrix using a glue (para. 0068).
Regarding claims 1, 5, and 14, Dadsetan teaches the limitations of the claimed invention, as described above. However, it does teach using a template material to help shape the cell-seeded matrix to its desired configuration. Sengun teaches shaping a template material to match the shape of the prepared defect site to form a shaped template material; shaping a cell-seeded matrix to match a shape of the shaped template material by placing the cell-seeded matrix on top of the template material and cutting the cell-seeded matrix to match the shape of the template material (paras. 0103-0106, 0112-0113), in order to ensure that the matrix implant will be properly sized and shaped for the defect site. The template material is shaped by passing the template material through the first cannula inserted at the first incision; observing the template material adjacent to the defect site; removing the template material from the first cannula and cutting it to approximate the size and/or shape of the defect site based on the observations; and repeating these steps as needed until the template material matches the size and/or shape of the defect site, which can be 10cm2 (paras. 0055, 0104-0114). It would have been obvious to one having ordinary skill in the art to modify the procedure of Dadsetan to include the shaping template taught by Sengun, in order to more easily ensure that the matrix will be properly sized and shaped for its implantation site. Such a modification would be made with a reasonable expectation of success.
Further regarding claims 1-3, Dadsetan, as modified by Sengun, teaches the limitations of the claimed invention, as described above. However, they are silent as to the details of the surgical method. Hart teaches that it is well known in the art that an arthroscopic surgical method comprises making at least two incisions in a subject adjacent to a defect to be treated, and the at least two incisions comprises a first incision and a second incision (pg. 28). The procedure addresses the cartilage at one of a knee, an ankle, an elbow, a shoulder, a hip, or a wrist of the subject (pgs. 24-28). The defect site is prepared by flushing the defect site; assessing and/or measuring the defect site; outlining the defect site; sculpting the defect site to remove damaged tissue; and debriding the cartilage down to subchondral bone (pgs. 24-28). These procedures allow the surgeon to better access and treat the defect site of the patient. It would have been obvious to one having ordinary skill in the art to modify the inventions of Dadsetan and Sengun, to comprise the surgical steps taught by Hart, as would be needed to allow the surgeon to better access and treat the defect site of the patient. Such a modification would be made with a reasonable expectation of success.
Dadsetan teaches the following regarding claim 2: the method of claim 1, wherein the defect comprises a cartilage defect (para. 0078).
Dadsetan teaches the following regarding claim 6: the method of claim 1, wherein the cell-seeded matrix comprises at least one of a bioresorbable material and collagen to form a matrix (paras. 0038-0043). Regarding the concentration of cells on the surface of the matrix, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal cell concentration needed to achieve the desired results and provide the desired therapeutic effect. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the cell concentration, would have been obvious at the time of applicant's invention in view of the teachings of Dadsetan, Sengun, and Hart. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Dadsetan teaches the following regarding claim 7: the method of claim 1, wherein the cells comprise chondrocytes (paras. 0015, 0040).
Dadsetan teaches the following regarding claim 8: the method of claim 1, wherein the cells comprise at least one of cells autologous to the subject and allogeneic cells (para. 0039).
Regarding claim 13, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal sized cannula needed to achieve the desired results and fit the implantation site and the matrix. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the diameter of the cannula, would have been obvious at the time of applicant's invention in view of the teachings of Dadsetan, Sengun, and Hart. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dadsetan in view of Sengun and Hart (hereinafter “Combination 1”), further in view of Nelson et al. (Pub. No.: US 2008/0167729; hereinafter “Nelson”).
Combination 1 teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the template material comprises at least one member of the group consisting of sterile aluminum foil, sterile paper, and an Esmarch bandage. Nelson teaches that it is well known in the art that sizing templates for implants comprise a paper (paras. 0034-0035), for the purpose of utilizing the material’s structure and flexibility. It is inherent in standard, proper medical practice that any elements used in surgery should be sterilized. It would have been obvious to one having ordinary skill in the art to modify the template material of Combination 1, to comprise a paper, as taught by Nelson, in order to utilize the material’s structure and flexibility. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of template material for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, 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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/ANN HU/Primary Examiner, Art Unit 3774
