DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/25/2025 has been entered.
Priority
This application claims foreign priority to 2011-289662, filed 12/28/2011.
Status of the Claims
Claims 1-9 are pending.
Specification
The objection to the disclosure has been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nakamura et al. (US 2008/0004713 A1), hereinafter “Nakamura.”
Regarding Claims 1-4, and 9, Nakamura discloses a method for treating an osteochondral defect in an osteochondral tissue comprising positioning a biphasic composite tissue in the osteochondral defect ([0049]) and holding the biphasic composite tissue in the osteochondral defect for a time sufficient for biological integration in the osteo chondral tissue ([0050]). The biphasic composite tissue comprises a first component that is a three-dimensional synthetic tissue (abstract) and a second component that is an artificial bone ([0075]). The synthetic tissue and artificial bone of Nakamura is disclosed to be positioned in an osteochondral defect and would be used to replace or cover the osteochondral defect (abstract). Nakamura further discloses that the three-dimensional synthetic tissue and the artificial bone are diphasic or attached to each other ([0075] describes the synthetic tissue and the artificial bone as biologically integrated, which would involve them being diphasic/biphasic or attached to each other).
Nakamura discloses the invention substantially as claimed, but does not specifically disclose that the artificial bone component of the biphasic composite tissue is positioned in the osteochondral defect with the artificial bone surface of the artificial bone at the synthetic tissue-artificial bone boundary surface depth of 2mm or greater to 4mm below the surface layer of the cartilage tissue (as is claimed in Claim 1), at 2mm or greater to 3mm below the surface layer of the cartilage tissue (as is claimed in Claim 4), is at 3mm below the surface layer of the cartilage tissue (as is claimed in Claim 9). Nakamura also does not specifically disclose that the total depths of the synthetic tissue and the artificial bone is the same as the osteochondral defect depth (as is claimed in Claim 2), or that the artificial bone is smaller in depth than the depth of the lost portion of subchondral bone tissue in the osteochondral defect, by an amount that is twice a depth of the lost portion of the surface layer of cartilage tissue, or less (as is Claimed in Claim 3).
Nakamura does disclose in [0181] that “the thickness of the implantable synthetic tissue varies depending on a part targeted by implantation, but can be determined as appropriate by those skilled in the art.” The size/thickness being determined by one skilled in the art would extend to the size/thickness of the artificial bone used in conjunction with the synthetic tissue as well. Nakamura further states that "a synthetic tissue or complex (the artificial bone and synthetic tissue would qualify as a complex) of any thickness can be produced, i.e., the size is not particularly limited.” The invention of Nakamura is capable of being paired with any defect, which would encompass larger defects, smaller defects, and defects of the same size, and which would determine the necessary depth of the positioning of the artificial bone. As the "osteochondral defect” as claimed is theoretical, the invention of Nakamura meets the limitations of the claims to have the artificial bone smaller in size than the depth of the lost portion of subchondral bone tissue in the osteochondral defect, a total of depth of the artificial bone and the three-dimensional synthetic tissue nearly the same as a depth of the osteochondral defect, and the artificial bone smaller in size than the depth of the lost portion of subchondral bone tissue in the osteochondral defect by twice the thickness of a cartilage or less. The composite tissue of Nakamura is similarly positioned at a depth of 2mm, 3mm, or greater to 4mm from the surface layer of the cartilage tissue, as would be determined by one skilled in the art.
Anatomically, as subchondral bone is the layer of bone found directly below the cartilage of a joint, it would be obvious to one having ordinary skill in the art to utilize the varying size/thickness as taught by Nakamura at the claimed depths as an osteochondral defect would be found at the claimed depths.
Regarding Claim 5, Nakamura discloses that the synthetic tissue is used in mammals ([0254]).
Regarding Claim 6, Nakamura discloses that the artificial bone is made of made of hydroxyapatite ([0075]).
Regarding Claim 7, Nakamura further discloses the composite tissue is used for the treatment of disease such as osteoarthritis [0337].
Regarding Claim 8, Nakamura discloses the cell can be a myoblast ([0166]), and that the extracellular matrix contains more of the collagen I and/or collagen III than collagen II ([0027]).
Response to Arguments
Applicant's arguments filed 03/25/2025 have been fully considered but they are not persuasive.
The applicant has presented the same arguments as addressed in the Final Office action. Again Nakamura and the applicant's invention are the same type of implants treating the same issues and both have the same outcomes and same effects desired. Both want to restore the natural cartilage and bone to its original levels. Nakamura clearly discloses that thickness should be adjusted depending on the target location and that it is adjusted based on the environment of the implantation site.
The applicant's arguments are focused on now calling their method unexpected and superior to the prior art. This is not persuasive because as explained previously Nakamura has a thickness range of 1-5 mm and discloses that it should be adjusted. Nakamura describes that the thicknesses in general of his implants should be "preferably a thickness of at least 2 mm, more preferably at least 3 mm, and even more preferably 5 mm" [0181]. The is consistent with the applicant's process of refining their thickness as spelled out in [0520]. In that paragraph that applicant spells out that 1-6 mm range is possible, but the range of 2-4 is more preferable and that about 3 is more preferable. Defining these values as ranges without showing criticality pushes one of ordinary skill in the art to conclude that the applicant is disclosing optimized values. The language of this paragraph is clearly consistent with simply narrowing values to achieve optimized ranges. There is no criticality disclosed by the original disclosure with respect to this dimension. There is nothing to indicate it is of utmost importance or that it was a turning point. This paragraph even provides a deficiency for both the 2 mm and 4 mm values of the range. Language saying that a value is preferred is not the same as saying that the value is critical.
With respect to the 13 references of the affidavit, as previously explained none of them have been shown to demonstrate that any of the authors taught away from the claimed approach or that they believed the approach to be insufficient. They simply teach that there are other approaches. Proof or another concept is not proof that the new concept does not work or cannot work. The applicant's claims that superior results are achieved from their claimed range is not even supported by their specification because [0520] spells out a clear deficiency with the end values of the range. It could be argued that the applicant's specified more preferable range of 3 mm has superior results but this is not clearly articulated or claimed.
Furthermore as demonstrated by the example provided in the affidavit one of ordinary skill could easily experiment with the device of Nakamura using the small range of values to obtain the optimal thickness within his original disclosed range and consistent with his disclosure of adjusting the range. Therefore when Nakamura is telling the reader that the thickness range is not set in stone, he is suggesting that it should be optimized by the user to achieve the best effects for the patient. Therefore the claimed range is considered a mere optimization not a unexpected result or unexpectedly superior method.
The applicant is advised to better define the structure of the implant to overcome the art of record. Focusing on picture type claims would be beneficial or additional material type limitations. If the applicant has claim limitations to propose the examiner is open to having an interview to move the case forward.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774