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 .
Response to Arguments
Applicant's arguments filed 06/12/26 have been fully considered but they are not persuasive.
The declaration under 37 CFR 1.132 filed 08/25/25 is insufficient to overcome the rejection of claims based upon 35 U.S.C. 103 as set forth in the last Office action. See the response to arguments mailed 01/14/26.
On pages 5-6 regarding prior art rejections Applicant argues the Examiner did not address the declaration’s statement that the configurations could only be achieved when using a weft knitting process.
The Examiner respectfully disagrees, pointing out this was addressed in the rejection of record along with amended claims.
On page 6 Applicant repeats arguments mailed 08/25/25 and saying the knit of Bayon could not have apertures open in two configurations.
The Examiner respectfully disagrees for the same reasons indicated in the action dated 03/25/25 and 01/14/26: 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 and Altman.
On page 6 Applicant states Downes only has plaited and twisted scaffolds before admitting Downes does refer to knitting. Applicant then again argues against only Downes, as opposed to the rejection of record which relies upon multiple references.
The Examiner agrees that Downes refers to knitted structures as Applicant observes in Downes’ description, and again reminds Applicant that arguments cannot be against references individually. 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 6-7 Applicant states benefits of their application. Applicant then states Bayon’s implant requires cell colonization and this is an essential feature.
The Examiner again reminds Applicant that the rejection of record is made over Downes in view of Bayon, making it unclear why essential features of Bayon are being discussed, when it is Downes that is being modified.
On page 7 Applicant argues amendments made to claim 1 are different from Bayon.
The Examiner again reminds Applicant that the rejection of record is made over Downes in view of Bayon, further in view of Altman. Please see the rejection below.
On pages 7-8 Applicant disagrees that Altman teaches both warp and weft knitting, and then agrees that both warp and weft are discussed. Applicant concludes that only warp knitting is discussed, and argues 3-needle atlas stitching is a warp knitting stitch. Applicant finishes by pointing out differences in dimension between Atlman and their invention.
The Examiner respectfully disagrees and notes Altman teaches the use of a 3-needle knitting process, as is discussed in [0132], and also teaches that warp and weft knits are equivalents in the art. The Examiner does not state that a 3-needle atlas stitch is a weft stitch as Applicant states. Further, dimensional differences between Applicant’s invention and Atlman are not understood to render Altman unusable as prior art as it appears Applicant might be suggesting.
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 and having elasticity and flexibility.
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, and have it 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, and the use of a 3-needle process would have accordingly been considered obvious to the person of ordinary skill.
Further, the Combination is understood to teach the knitted body made of PCL and including apertures, formed using a three-needle weft-knitting process, as having elasticity and flexibility (Downes [0032]-[0033] teaches the material can be a homopolymer of PCL with a molecular weight of 10,000-100,000 Daltons; Applicant’s specification page 5 columns 9-17 homopolymer of PCL with a molecular weight of 10,000-100,000. The material of PCL, when knit and constructed as is described in the Combination is understood to have elasticity and flexibility based on the materials and construction being the same as Applicant’s).
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
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/25/26
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