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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/25 has been entered.
Response to Arguments
Applicant's arguments filed 08/25/25 have been fully considered but they are not persuasive.
On pages 5-6 regarding prior art rejections Applicant agrees Downes references knitting, but states “plaiting” is a preferred method. Applicant conclude a person of ordinary skill would be “unlikely” to select a knitted body.
The Examiner respectfully disagrees, referring to MPEP 2123 (II) which details how nonpreferred embodiments still constitute prior art.
On page 6 Applicant argues Downes does not teach how apertures would be open in a stretched or unstretched configuration, and argues that if a knitted body is selected, for example one with apertures as is seen in Figures 17-18, it isn’t apparent that these “apertures” would be “open”.
The Examiner respectfully notes that by definition, something which is “knit” include apertures of some size or another. A “knit” is a fabric “made by interlacing yarn or thread in a series of connected loops with needles” (Merriam-Webster). Loops are considered to be apertures. An aperture is also inherently understood to be “open”, since the definition of an aperture is literally “an opening or open space: hole” (Merriam-Webster). Arguments with relation to figures 17-18 are unclear, since these are not described by Downes as showing a knit.
On pages 6-7 Applicant argues further that Bayon does teach a knitted body would have apertures which are open in a stretched configuration, and argues [0026] of Bayon teaches a knit being contained within a porous collagen matrix, meaning the knit is “not open to allow for in-growth of cells”.
The Examiner respectfully disagrees for the same reasons indicated in the action dated 03/25/25: this argument is not persuasive, since it is drawn towards arguments against Bayon alone, when the rejection of record is over Downes in view of Bayon. Notably, the Combination does not include any porous matrix, making this argument unclear. Additionally, the fact that there are pores in a matrix used in Bayon (not the Combination) indicates that the matrix does not close any apertures, which renders the argument unpersuasive (Bayon [0039]). Additionally, the claims do not mention any requirement for ingrowth through aperture (although Bayon actually does teach that their matrix does not impede ingrowth [0013]), making this argument even less clear.
On page 7 Applicant argues Altman also does not teach “the importance of the apertures in the knit, and whether they remain open in a stretched, loaded configuration”.
The Examiner respectfully notes no requirement for Altman to teach “the importance of the apertures in the knit” in order for Altman to be used as prior art.
On page 7 Applicant argues further that the pillar stitch of Bayon is prepared using warp knitting, and conclude this is an “essential feature of the implant” since it gives “good tensile strength in the longitudinal direction” ([0028]) and argues a weft knitting would not have a similar effect.
The Examiner respectfully notes it appears the Applicant is arguing against Bayon individually as opposed to the Combination of references. 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).
On pages 7-8 Applicant argues further that amended claims overcome the rejection of record.
The Examiner respectfully refers to the rejection of record regarding amened claims.
On page 8 Applicant argues Shah is “incompatible” with Downes, Bayon, and Altman since Shah does not reference “a knitted body”.
The Examiner respectfully notes “incompatibility” is not a standard for which prior art references are measured according to the MPEP, making this argument unpersuasive.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-8, 16 is/are rejected under over 35 U.S.C. 103 as being unpatentable over Downes et al. (US 20110238178 A1) hereinafter known as Downes in view of Bayon et al. (US 20110264237 A1) hereinafter known as Bayon, and further in view of Altman et al. (US 20080300683 A1) hereinafter known as Altman.
Regarding claim 1 Downes discloses a tendon repair scaffold ([0021]; [0023]) comprising a knitted body ([0044] knitted secondary fiber bundles) made of a yarn ([0067]) comprising PCL ([0030]),
wherein the knitted body comprises a plurality of apertures (it is considered to be inherent that a knit body includes apertures of some dimension, as knitting involves interlacing yarn via connected loops),
wherein the apertures are open at and between a first configuration in which the knitted body is unloaded (unstretched) and has a first length, and a second configuration in which the knitted body is loaded and has a second length which is greater than the first length (it is considered within a knit that stretching (“loading”) the loops of the knit would inherently increase its length somewhat),
but is silent with regards to the second length being at least 10% greater than the first length,
and the knitted body being knit by a 3-needle weft knitting process.
However, regarding claim 1 Bayon teaches that knitted scaffolds ([0024]) include apertures (this is considered inherent within a knit; alternatively, see also the Abstract along with [0018] pores/holes/cavities within a knit) which are open in an unloaded (unstretched) configuration and open in a loaded (stretched) configuration when the scaffold body has a length greater than when unstretched (it is considered to be inherent within a knit with apertures that stretching will inherently lengthen the knit to increase the length of the scaffold. See also [0026]), wherein the second length is at least 10% greater than the first length ([0026] less than 20% elongation at a 100N force), and wherein a knitted scaffold can be knit via a warp knit ([0028] pillar stitch weave). Further, Altman teaches wherein knitted tendon repair scaffolds can utilize a weft knit as a known alternative to a warp knit ([0076]) and utilize a 3-needle knitting process ([0132]). Downes, Bayon, and Altman are involved in the same field of endeavor, namely tendon repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to look to Bayon for teaching that knit products include apertures and loaded/unloaded configurations that allow for length change of the scaffold when stretching/loading. Additionally, it would have been obvious to one of ordinary skill to modify the type of knit used by the Combination so that it is a weft knit done via a 3-needle knitting process as is taught by Altman since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known process of knit would have been obvious to try. Additionally, the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C), and the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). The substitution of a weft knit process in a 3-needle process would have accordingly been considered obvious to the person of ordinary skill.
Regarding claim 3 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
wherein Downes further discloses the yarn comprises a plurality of fibers comprising PCL ([0032]).
Regarding claim 16 the Downes Bayon Altman Combination teaches the scaffold of claim 3 substantially as is claimed,
wherein Downes further discloses the fibers are made by electrospinning and wherein the fibers are aligned ([0077]), and the yarn is formed by twisting the plurality of fibers ([0020], [0034], [0042]).
Regarding claim 4 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
wherein Downes further discloses an average diameter of the fibers is less than 1 µm ([0045]).
Regarding claim 5 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
wherein Downes further discloses an average diameter of the yarn is less than 500 µm ([0038]; [0046]).
Regarding claim 6 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
wherein Downes further discloses an first length of the knitted body can be 15-25 mm ([0037] the scaffold can have a length up to 40 cm (e.g. no lower limit), but the appropriate length is selected based on the tendon to be repaired). The courts have held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 7 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
wherein Downes further discloses an average width of the knitted body in the first configuration can be 1.5-2.5 mm ([0038] the scaffold can have a width between 50 µm to 10 cm or more; see also [0046] the secondary bundles can have a diameter from 100-500 microns, and a plurality of these can be bundled together to form the scaffold ([0047]), and three secondary bundles can be used ([0139] to create a diameter of the scaffold being 500x3=1500 microns, or 1.5 mm.).
Regarding claim 8 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
but is silent with regards to the apertures individually having an area of at least 10,000 square microns in the first and second configuration.
However, regarding claim 8, the Examiner refers to pages 19-20 of Applicant’s specification, which compares the prior art of Downes and the area of their apertures to that of the instant application. (Downes is a continuation of PCT/GB2009/002874, which is the international application number of WO 2010/067086 referenced in Applicant’s specification.) Notably, Applicant’s specification mentions that Downes’ plaited structure has only one open aperture when loaded with an area between 10,000-12,000 microns squared (Applicant’s figure 12). However, the experiment applied in Applicant’s specification (pages 19-20, figures 12-13) is done against Downes’ plaited structure. The rejection of record on the other hand (the Downes Bayon Altman Combination), which includes a knit structure (e.g. the same as Applicant’s), is understood to inherently, if not obviously, function in the same way as is described in Applicant’s specification.
Claims 9-10, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Downes, Bayon, and Altman as is applied above, further in view of Shah (US 4642119 A).
Regarding claims 9 and 17 the Downes Bayon Altman Combination teaches the scaffold of claim 1 substantially as is claimed,
but is silent with regards to there being a first tendril extending from a first end of the knitted body, and a second tendril extending from a second end of the knitted body.
However, regarding claims 9 and 17 Shah teaches tendon replacements can have a first and second tendril extending from the first and second ends of the tendon body (Column 4 lines 65-68). Downes and Shah are involved in the same filed of endeavor, namely tendon repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the scaffold of the Downes Bayon Altman Combination so that there are tendrils extending from the end(s) of the knitted body of Downes in order to provide a mechanism to sew the tendon scaffold in place within a patient during implantation.
Regarding claims 10 and 18 the Downes Bayon Altman Shah Combination teaches the scaffold of claims 9/17 substantially as is claimed,
wherein Shah further teaches the first and second tendril are made of the same material of the tendon body (Column 4 lines 65-67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 10/27/25