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
Claims 10-13, 16, 19, and 22 have been amended. 35 U.S.C. 112 rejection has been withdrawn.
Applicant’s arguments, filed November 21, 2025, with respect to the rejection(s) of claims 1-3 and 5-23 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference Evans regarding the amended limitations of wherein the tissue repair material comprises porous, compressible pellets and the tissue repair material is porous and compressed.
Election/Restrictions
Newly submitted claim 24 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The inventions of claims 1-23 (seen in Fig. 3) and claim 24 (seen in Figs. 1-2) are directed to related methods. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the invention of claims 1-23 have a materially different mode of operation, as the invention does not require the use of elongate obstructions extending over a length of the barrel. The invention is instead directed towards elongate channels extending over a length of the barrel. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 24 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
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.
Claims 1-3 and 5-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0405364 to Shimko in view of U.S. Patent Pub. No. 2003/0236573 to Evans et al.
As to Claim 1, Shimko discloses a method of forming a tissue repair device [0009]. The method comprises providing a syringe (10) comprising a barrel (12) that is configured or configurable to be in fluid communication with a tip (of 19, Fig. 1, [0217]). The barrel comprises an interior wall (formed by 14, tissue repair material [0221], and at least one elongate channel (distal to plunger 20) extending over a length of the barrel (Fig. 1), the channel being defined by the interior wall and the tissue repair material (Fig. 1, [0217]), wherein the tissue repair material is porous and compressed [0217]. The method includes inserting a hydrating fluid (34) into the channel to form an extrudable tissue repair material [0218, 0221].
As to Claim 2, Shimko discloses a method wherein the hydrating fluid (34) is inserted into the barrel (12) by attaching a second syringe (24) containing the hydrating fluid to the tip in fluid communication with the barrel (via 21, [0218, 0220-0221]), and dispensing the hydrating fluid from the second syringe into the barrel via the tip [0218, 0220-0221].
As to Claim 3, Shimko discloses a method further comprising a second channel (portion of 26 distal to plunger 32) positioned opposite the first channel (Fig. 1), wherein the second channel is defined by the interior wall of the barrel and the tissue repair material (equal dimensions of 14 and 26 seen in Fig. 1, [0217-0218]).
As to Claim 5, Shimko discloses a method wherein the tissue repair material comprises polymer fibers [0260].
As to Claim 6, Shimko discloses a method wherein the tissue repair material comprises a lyophilized sponge comprising collagen fibers and mineral particles [0016, 0221-0223].
As to Claim 7, Shimko discloses a method wherein the mineral is present as particles having an average particle diameter of from 0.05 to 1 mm [0117].
As to Claim 8, Shimko discloses a method wherein the tissue repair material comprises from 50 to 95 wt% of mineral and from 5 to 50 wt% of collagen, based on the total weight of the dry sponge or the solids of the slurry, respectively [0096].
As to Claim 9, Shimko discloses a method wherein the tissue repair material comprises polymer fibers having an average length of from 1 mm to 5 mm [0102].
As to Claim 10, Shimko discloses a method wherein the pellets comprise the shape of a triangular prism, a rectangular prism, other polygonal prism, or a cylinder [0101].
As to Claim 11, Shimko discloses a method wherein the maximum dimension of the pellets is less than the inner diameter of the tip [0151, 0182].
As to Claim 12, Shimko discloses a method wherein the pellets are compressed from 40% to 60% by volume [0201].
As to Claim 13, Shimko discloses a method wherein the at least one elongate channel comprises from 1.5 to 4% of the total filled volume of the barrel [0247].
As to Claim 14, Shimko discloses a flowable solution, gel, paste, or putty capable of extrusion formed according to the method of claim 1 [0108, 0222].
As to Claim 15, Shimko discloses a tissue repair device [0009]. The device comprises a syringe (10) comprising a barrel (12) in fluid communication with a tip (of 19, Fig. 1, [0217]). The barrel comprises an interior wall (formed by 14, tissue repair material [0221], and a porous, compressed tissue repair material (22) present in the barrel [0217]. The tissue repair device comprises at least one elongate channel (distal to plunger 20) extending over a length of the barrel through the tissue repair material (Fig. 1, [0217]), the channel being defined by the interior wall and the tissue repair material (Fig. 1, [0217]), wherein the tissue repair material comprises collagen fibers and mineral particles [0016, 0221-0223].
As to Claim 16, Shimko discloses a tissue repair device wherein channels comprise from 1 to 10% of the total filled volume of the barrel [0247].
As to Claim 17, Shimko discloses a tissue repair device wherein the density of the tissue repair material in the barrel is from 250 to 300 kg/m3 [0200-0201].
As to Claim 18, Shimko discloses a tissue repair device wherein the syringe has a maximum volume of 1 to 15 cubic centimeters [0259].
As to Claim 19, Shimko discloses a tissue repair device wherein the maximum dimension of the pellets is 6 mm or less [0151].
As to Claim 20, Shimko discloses a tissue repair device wherein the mineral has an average particle diameter of from 0.05 to 2 mm [0117].
As to Claim 21, Shimko discloses a tissue repair device wherein the tissue repair device has two elongate channels (distal to plunger 20, and distal to plunger 32, Fig. 1).
As to Claim 21, Shimko discloses a tissue repair device wherein each channel has a diameter of from 2 to 5 mm [0259].
As to Claim 23, Shimko discloses a method comprising extruding the extrudable tissue repair material thereby forming an extruded tissue repair material [0042], and inserting the extruded tissue repair material into a tissue defect in a human or animal body [0226, 0233, 0251].
As to Claims 1-3 and 5-23, Shimko discloses the claimed invention except for wherein the tissue repair material comprises porous, compressible pellets and the tissue repair material is porous and compressed.
Evans discloses a method of forming a tissue repair device [0126-0129] including wherein the tissue repair material (14) comprises porous, compressible pellets and the tissue repair material is porous and compressed [0129] in order to provide a material having a high expansion ratio (wet-to-dry) and good mechanical wet strength [0126].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of forming a tissue repair device of Shimko with the compressible pellet modification of Evans in order to provide a material having a high expansion ratio (wet-to-dry) and good mechanical wet strength.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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