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 Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Applicant argues Petito does not teach an osteochondral tissue repair stent. Examiner is unclear on the argument, since the claim limitation of an “osteochondral tissue repair stent” has already been disclosed by Tampieri (see page 5 of the non-final rejection, as well as paragraph [0001] in Tampieri). It appears Applicant is arguing that all the references do not teach all limitations of the claims. However, that is only necessary for a rejection under 35 U.S.C. 102, and is not necessary in order for a rejection under 35 U.S.C. 103, which is what this rejection is based on. The Examiner reminds Applicant that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. See MPEP 2145(IV). The Examiner has applied Petito only to teach that it would be obvious to include a known growth-promoting material to the device of Tampieri, since it is a device intended for growth-promotion.
Applicant has argued there is evidence of criticality of the molecular weights of the recombinant collagen and the sodium hyaluronate. The arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c). Evidence in the record would be a declaration or affidavit by the inventor. The data sets pointed to are from tables 1-2 and do use different molecular weights of the materials, but they also all have varying concentrations of the collagen and sodium hyaluronate in the two feed solutions. There are too many variables changing in the examples for them to support this particular argument regarding molecular weight.
Claim Status
The claim objection and 35 U.S.C. 112(b) rejections have been overcome.
Claims 16-19 are examined below.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tampieri (US 2009/0232875 A1) in view of Derwin (US 2016/0058534 A1) and Petito (US 2002/0025921 A1).
Regarding claim 16, Tampieri discloses a double-layer osteochondral tissue repair stent (1, multilayer structure, fig. 1), comprising:
a first layer (3, lower layer, fig. 1), wherein the first layer is made of raw materials comprising recombinant collagen (¶ [0048], ¶ [0059]) and hydroxyapatite (¶ [0048]); and
a second layer (2, upper layer, fig. 1), wherein the second layer is made of raw materials comprising recombinant collagen (¶ [0047], ¶ [0059]).
Tampieri fails to teach the molecular weight of recombinant collagen. However, Derwin discloses a biocompatible tissue that includes a molecular weight of the recombinant collagen is 95 kD-100 kD (¶ [0037]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Tampieri to include the molecular weight of recombinant collagen as taught by Derwin since it is a simple substitution of one known element for another to obtain predictable results.
Tampieri and Derwin fail to teach sodium hyaluronate and its molecular weight. However, Petito discloses a gel to facilitate the growth and protection of healing tissue that includes the use of sodium hyaluronate and a molecular weight of the sodium hyaluronate is 90 kD-110 kD (¶ [0109]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Tampieri and Derwin to include sodium hyaluronate as taught by Petito since it is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 19, Tampieri further discloses a thickness of the first layer is 2-4 mm (¶ [0057]), and a thickness of the second layer is 3-6 mm (¶ [0056]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tampieri in view of Derwin and Petito as applied to claim 16 above, and further in view of Kawamura (US 2006/0292350 A1).
Regarding claim 17, Tampieri in view of Derwin and Petito fails to teach porosity of the two layers. However, Kawamura discloses a multilayered porous composite that includes a porosity of the first layer is 80%-97% (¶ [0032]), and a porosity of the second layer is 58%-86% (¶ [0028]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Tampieri, Derwin and Petito to include porosity of the two layers as taught by Kawamura since it is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 18, Tampieri in view of Derwin and Petito fails to teach the size of aperture in the two layers. However, Kawamura further discloses an aperture of the first layer is 100-200 µm (¶ [0032]), and an aperture of the second layer is 50-80 µm (¶ [0028]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Tampieri, Derwin and Petito to include the size of aperture in the two layers as taught by Kawamura since it is a simple substitution of one known element for another to obtain predictable results.
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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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