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 .
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) 21-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2010/0297208 to Fry et al. (Fry hereinafter) in view of US Pre-Grant Publication 2004/0175408 to Chun et al. (Chun).
Regarding claim 21, Fry teaches a method of tissue repair comprising implanting (see paragraphs 16, 82) a resorbable fiber matrix (scaffold) at a surgical site (paragraph 16), the matrix having a first non-woven fiber composition (polymer, see paragraph 25) and a second non-woven fiber composition (copolymer, see paragraph 29) each of which is resorbable. Fry teaches that the matrix may reinforce soft tissue (paragraph 82). Further, as best understood by the examiner, Fry teaches an architecture resembling a native extracellular matrix. Fry does not explicitly teach tensile strength. Chun teaches another tissue reinforcement implant generally, and particularly teaches that “suitable elastomers should have a tensile strength greater than about 500 psi” (paragraph 40). Chun thus teaches that tensile strength should be selected in a tissue implant to be appropriate to the process. Beyond that, the examiner notes that a tensile strength measured in units of force (i.e. Newtons) is dependent on the dimensions (particularly cross-sectional area) of the article being measured, as is generally understood in the art. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to select a material having an appropriate tensile strength to the application of the tissue repair implant of Fry as taught by Chun. Any remaining difference therewith, including the dimensions of the matrix is merely a difference in relative dimensions, which has been held to be non-obvious (MPEP 2144.04 IV. A) when evidence of criticality is not present (as is currently the case).
Regarding claim 22, Fry teaches resorption (paragraphs 27, 59).
Regarding claim 23, Chun teaches closing the surgical site after implantation (paragraph 104), which those of ordinary skill in the art will appreciate is a conventional step encouraging healing in the patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to close the surgical site as taught by Chun after implantation of the matrix of Fry in order to promote healing.
Regarding claims 24 and 25, Chun teaches securing an implant with sutures to affix the implant to a damaged site (paragraph 78). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to secure the matrix with sutures as taught by Chun in order to affix the implant to a target site.
Regarding claim 26, Chun teaches cutting an implant to size in order to closely mimic the shape of the defect it is being used to repair (paragraph 34). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to cut the implant of Fry to fit the surgical site in order to mimic the shape of the defect as taught by Chun.
Regarding claim 27, Fry teaches hydrating the fiber matrix (paragraph 135) prior to implantation.
Regarding claim 28, Fry teaches pore sizes from 1-25 microns (paragraph 69, one micron equaling one micrometer), which overlaps the claimed range and renders the claim obvious.
Regarding claim 29, Fry teaches pore sizes from 1.2-4.0 microns (paragraph 18), which falls into the claimed range and renders the claim obvious.
Regarding claims 30-32, Fry teaches the use of poly(lactic-co-glycolic) acid (paragraph 29) and polydioxanone (paragraph 31) in a blend (paragraph 31).
Regarding claim 33, Fry teaches that the fiber compositions break down into glycolic acid (paragraph 27).
Response to Arguments
Applicant's arguments filed 27 July 2026 have been fully considered but they are not persuasive.
With respect to the arguments regarding indefiniteness, the examiner is persuaded and withdraws the rejection herein based on the allowance of identical language in previous applications.
With respect to the distinction between the tensile strength of Chun’s elastomers and the implant of claim 21, the examiner is not persuaded. First, it is not clear that 15 Newtons is the maximum possible tensile strength which would infringe on the claim. In particular, as generally understood, tensile strength requirements are expressed as a minimum. As such, since the tensile strength of Chun’s elastomers is in excess of the requirement of the claimed invention, it has a tensile strength of at least “about 1 Newton to about 15 Newtons”. Second, as noted above, the courts have held that where the difference between the prior art and a claimed invention relates solely to relative dimensions thereof, a prima facie case of obviousness is present (MPEP 2144.04 IV. A). As such, since tensile strength is a function of relative dimensions, it is further the case that even if the claim were limited to a maximum of 15 Newtons of tensile strength, the difference between an apparatus modified in view of Chun and that of the claim is only one of relative cross-section, which is a relative dimension and therefore a prima facie case of obviousness is present. The same analysis relates to the dimensions recited in the present amendment.
In view of the above, the examiner maintains that the claimed invention is obvious.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 11 August 2026
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