DETAILED ACTION
Receipt is acknowledged of applicant’s Response to Restriction Requirement filed 8/12/2025.
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 .
Status of the Claims
Claim 5 has been amended. No claims were cancelled or newly added. Accordingly, claims 1-20 remain pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19), R1 species –(CH2)-O-(CH2)b-O-CH2-, wherein b is 4, R2 species -CH2CH3, X1 species -O-, and support element species braided in the reply filed on 8/12/2025 is acknowledged.
Claims 4, 5 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Accordingly, claims 1-3 and 6-19 are currently under examination.
Information Disclosure Statement
The IDS’s dated 3/22/20222 and 9/28/2022 have been considered. Signed copies are enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites, “wherein the crosslinked collagen-based covering comprises a sheet of the collagenous substrate that has at least one fold along a length thereof, the fold being configured to facilitate a more uniform height or thickness of the orthopedic implant along the middle portion of the support element”. The phrase “the fold being configured to facilitate a more uniform height or thickness” is indefinite because it is unclear what structural element provides the function of a more uniform height or thickness. Further, the term “more” is a relative term which renders the claim indefinite. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites, “wherein the crosslinked collagen-based covering covers at least the first main surface, the second main surface, and the first side edge”.
Claim 12 recites, “wherein the crosslinked collagen-based covering is wrapped around at least the middle portion of the support element”.
Claims 11 and 12 depend from claim 6. Claim 6 recites, “a crosslinked collagen-based covering positioned around at least part of a length of the middle portion of the support element so that the crosslinked collagen-based covering covers at least part of the length of the first main surface, the second main surface, and the first side edge of the middle portion of the support element”.
Claim 6 sets out limitations that are substantially similar to the limitations of claims 11 and 12. Accordingly, the limitations of claims 11 and 12 do not properly further limit the subject matter of claim 6.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3, 6-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Coleman (US 2017/0143551 A1, May 25, 2017, hereafter as “Coleman”), Grafton (US 2005/0192631 A1, Sep. 1, 2005, hereafter as “Grafton”), Mezger et al. (US 2013/0030526 A1, Jan. 31, 2013, hereafter as “Mezger”) and Kim et al. (KR 2017/0135677 A, Dec. 8, 2017, machine translation, hereafter as “Kim”).
The claimed invention is drawn to an orthopedic implant for treatment of a distal extremity joint, the orthopedic implant comprising: a support element comprising: a first end portion; a second portion; and a middle portion between the first end portion and the second end portion, the middle portion having a first main surface having a first width, a second main surface opposite to the first main surface, a first side edge surface, and a second side edge surface; and a crosslinked collagen-based covering positioned around at least part of a length of the middle portion of the support element so that the crosslinked collagen-based covering covers at least part of the length of the first main surface, the second main surface, and the first side edge of the middle portion of the support element, the crosslinked collagen-based covering comprising: a collagenous substrate comprising collagen strands, a crosslink, and a quenched crosslinking agent; wherein the crosslink comprises a crosslinking unit, a first amine, and a second amine, the first amine being part of a first collagen strand of the collagenous substrate and the second amine being part of a second collagen strand of the collagenous substrate, the crosslink being represented by Formula (I):
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wherein the quenched crosslinking agent is bonded to the collagenous material through a third amine of the collagenous substrate and is represented by Formula (II):
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196
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where R1 is selected from the group consisting of optionally substituted alkylene, optionally substituted polyether, and optionally substituted polyamino; R2 is selected from the group consisting of optionally substituted alkylene, optionally substituted polyether, and optionally substituted polyamino; X1 is selected from the group consisting of -O- and -NH- where each instance of "~~~~" of Formulae (I) and (II) represents a portion of the collagenous substrate.
Regarding instant claims 1, 2, 8 and 9, Coleman teaches suture delivered patches adapted for interposition, augmentation or repair devices for use in tendon and ligament repair, including rotator cuff repair, have been developed as well as methods for their delivery using suture guided arthroscopic methods (orthopedic implant for distal extremity joint; see abstract). Said patches may be delivered using anchored sutures already in use during a surgical repair including, open, minimally invasive, endoscopic, and arthroscopic repair procedures (implant; see abstract). Coleman illustrates a suture guided patch having a form and a single suture conduit with a suture (a support element comprising a first end portion, a second end portion and a middle portion) shown extending through the conduit from the proximal end to the distal end (covering positioned around at least part of a length of the middle portion of the support element so that the covering covers at least part of the length of the first main surface, the second main surface and the first side edge of the middle portion of the support element; see Figure 9; [0032] and [0145]). Coleman teaches that the patch comprises biologically derived materials including collagen ([0140]).
Coleman does not explicitly disclose the support element having a middle portion that has a first main surface having a first width, a second main surface opposite to the first main surface, a first edge surface, and a second side edge surface, however, one of ordinary skill in the art would understand that the suture 8 will inherently have a middle portion that has two opposing sides as it has a 3-dimensional shape.
Additionally, Coleman does not explicitly disclose the support element having first side edge surface and second side edge surface.
However, Grafton teaches a suture that has a middle portion that is in the form of a flat braid for the purpose of tissue repair requiring high strength sutures including orthopedic repairs such as rotator cuff repair, tendon repair, etc. (abstract; [0013]; claim 1).
Coleman and Grafton and both drawn to implantable devices comprising sutures for the purpose of orthopedic tissue repair, thus, it would have been prima facie obvious to one of ordinary skill in the art to include a suture a middle portion that has a first main surface having a first width, a second main surface opposite to the first main surface, a first edge surface, and a second side edge surface such as the flat braided suture of Grafton into the invention of Coleman with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Coleman generally teaches braided sutures ([0130]-[0132]) and Grafton specifically teaches flat braided sutures as being suitable for same purpose of orthopedic tissue repairs and Grafton further teaches that the flat braided suture effectively provides high strength needed for such repairs.
Coleman is silent to a crosslinked collagen comprising collagen strands, a crosslink, and a quenched crosslinking agent; wherein the crosslink comprises a crosslinking unit, a first amine, and a second amine, the first amine being part of a first collagen strand of the collagenous substrate and the second amine being part of a second collagen strand of the collagenous substrate, the crosslink being represented by Formula (I) wherein the quenched crosslinking agent is bonded to the collagenous material through a third amine of the collagenous substrate and is represented by Formula (II) where R1 is selected from the group consisting of optionally substituted alkylene, optionally substituted polyether, and optionally substituted polyamino; R2 is selected from the group consisting of optionally substituted alkylene, optionally substituted polyether, and optionally substituted polyamino; X1 is selected from the group consisting of -O- and -NH- where each instance of "~~~~" of Formulae (I) and (II) represents a portion of the collagenous substrate.
Mezger teaches a degradable bioprosthesis made of collagen-based material having amine-based and ester-based crosslinks and a method forming thereof (abstract). Mezger teaches that by controlling the ratio of amine-based to ester-based crosslinks, by controlling the level of crosslinking, or by controlling both of these features, degradable bioprostheses with tailored degradation rates can be synthesized (abstract). Mezger also teaches that the degradable bioprosthesis have degradation rates that are tailored to allow their use in particular medical applications including in wound healing, tissue repair, and tissue supplementation (abstract). Mezger teaches that the degradable bioprosthesis comprises a collagenous substrate comprising collagen strands, a crosslink; wherein the crosslink comprises a crosslinking unit ([0020] – crosslink A), a first amine, and a second amine ([0022] – there are two amine groups located in crosslink A), the first amine being part of a first collagen strand of the collagenous substrate and the second amine being part of a second collagen strand of the collagenous substrate ([0022] – both amines are attached to collagenous strands), the crosslink being represented by Formula (I) ([0022] – Formula I is created when R-1 is substituted into crosslink A): where R1 is selected from the group consisting of optionally substituted alkylene, optionally substituted polyether, and optionally substituted polyamino ([0022] – R3 (same as R1) can be –(O(CH2)n)m- which is a polyether); where each instance of "~~~~" of Formulae (I) and (II) represents a portion of the collagenous substrate ([0022] – the wavy line indicates the collagen strands which is a part of the collagenous substrate). Mezger also teaches the particular crosslinking agent, 1,4 butanediol diglycidyl ether (BDDGE) ([0038]). Mezger further teaches the inclusion of a blocking agent (quenching agent) that is capable of forming a stable covalent bond with a free amine or carboxyl groups in the proteins, thereby blocking the crosslinking ([0069]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chemical composition of the device of Coleman to have a crosslinking structure represented by Formula I such as BDDGE as taught by Mezger for the purpose of creating a crosslinking agent which is readily available, inexpensive, and effectively crosslinks tissue (Mezger: [0012]) with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Mezger teaches that a crosslinked collagen bioprosthesis using the crosslinker, BDDGE, effectively allows for tailoring the bioprosthesis to the desired degradation rate for the same purpose of tissue repair.
Kim teaches a device made of collagen (page 7, 4th paragraph; paragraph bridging pages 8-9), Kim teaches crosslinking agents (page 8, paragraphs 4-5) as well as quenching agents (page 12, paragraph 12). Kim teaches wherein the quenched crosslinking agent is bonded to the collagenous material through a third amine of the collagenous substrate and is represented by Formula (II) (page 12, paragraph 12 - crosslinking agent is quenched with aqueous solution of ethanol), R2 is selected from the group consisting of optionally substituted alkylene, optionally substituted polyether, and optionally substituted polyamino; X1 is selected from the group consisting of -O- and -NH-. The instant specification states that the crosslinking agent is quenched in an ethanol solution ([0121]) in order to achieve the quenched crosslinking agent structure of Formula II. When the crosslink of Mezger is quenched with ethanol as taught by Kim, it would create the structure of Formula II with X1 being -O- and R2 being a polyether. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the quenched crosslinking agent of Kim such as ethanol into the invention of Coleman/Mezger with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Mezger generally teaches blocking/quenching agents for collagen crosslinking and Kim specifically teaches ethanol is a suitable quenching agent for the purpose of collagen crosslinking. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination (MPEP 2144.07).
Regarding instant claims 3 and 6, the references teach the elements discussed above. Coleman further teaches that the suture is braided ([0130]-[0132]).
Regarding instant claim 7, the references teach the elements discussed above. Said claim recites, “wherein the orthopedic implant is sized and configured for use in an abdominal hernia treatment procedure”. Coleman further teaches that the patch can be sized and shaped depending on the surgical site in need of repair ([0072], [0116] and [0267]). It is noted that the instant claims are product claims and any intended use recitation such as “for use in an abdominal hernia treatment procedure” does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding instant claim 10, the references teach the elements discussed above. Coleman illustrates a covering that does not cover the first end portion of the second end portion of the support element (i.e., suture) (Fig. 9).
Regarding instant claims 11 and 12, the references teach the elements discussed above. Coleman, as discussed above, illustrates a covering that covers/wraps around the middle portion of the support element (i.e., suture) (Fig. 9) and Grafton, as discussed above, teaches a suture that has a middle portion that is in the form of a flat braid for the purpose of tissue repair requiring high strength sutures including orthopedic repairs such as rotator cuff repair, tendon repair, etc. (abstract; [0013]; claim 1). Coleman and Grafton and both drawn to implantable devices comprising sutures for the purpose of orthopedic tissue repair, thus, it would have been prima facie obvious to one of ordinary skill in the art to include a suture a middle portion that has a first main surface having a first width, a second main surface opposite to the first main surface, a first edge surface, and a second side edge surface such as the flat braided suture of Grafton into the invention of Coleman with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Coleman generally teaches braided sutures ([0130]-[0132]) and Grafton specifically teaches flat braided sutures as being suitable for same purpose of orthopedic tissue repairs and Grafton further teaches that the flat braided suture effectively provides high strength needed for such repairs.
Regarding instant claim 13, the references teach the elements discussed above. Coleman also teaches suture patches having a sheet structure that is wrapped around at least the first main surface, the second main surface, and the first side edge surface of the middle portion of the support element (Fig. 26A and Fig. 27).
Regarding instant claim 14, the references teach the elements discussed above. Coleman also teaches suture patches having a sheet structure that is wrapped continuously around the first main surface, the second main surface, the first side edge surface, and the second side edge surface of the middle portion of the support element (Fig. 26A and Fig. 27).
Regarding instant claim 15, the references teach the elements discussed above. Coleman also teaches a patch having at least one fold along a length thereof and illustrates a uniform height ([0180]-[0181]; Fig. 43E and Fig. 43F).
Regarding instant claim 17, the references teach the elements discussed above. Coleman also teaches a patch having at least one fold that is aligned with the first side edge surface ([0180]-[0181]; Fig. 43E and Fig. 43F). Fig. 43E and Fig. 43F show a dotted line which indicates the suture conduit 52 ([0147]). The combination of the flat suture structure of Grafton within the suture conduit of Coleman would necessarily yield at least one fold being aligned with the first side edge surface of the suture (i.e., support element).
Regarding instant claim 18, the references teach the elements discussed above. Coleman also teaches a patch having at least one fold that is aligned with the suture conduit ([0180]-[0181]; Fig. 43E and Fig. 43F). Fig. 43E and Fig. 43F show a dotted line which indicates the suture conduit 52 ([0147]). Fig. 9 of Coleman further illustrates that the thickness of the channel/conduit has a thickness (diameter) that is less than (i.e., reduced) the thickness of the patch/covering.
Regarding instant claim 19, the references teach the elements discussed above. Fig. 9 of Coleman illustrates that the thickness of the channel/conduit has a thickness (diameter) that is less than (i.e., reduced) the thickness of the patch/covering. Coleman also teaches that the patch thickness, sizing, etc. and suture conduit can be tailored to the desired parameters depending on the requirements of the tissue repair ([0122], [0170] and [0182]). While Coleman does not explicitly teach a channel thickness of 0.05 mm to 0.15 mm and a collagen-based covering thickness of 0.3 mm to 0.7 mm, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the conduit and patch dimensions of the implant of Coleman/Grafton/Mezger/Kim by way of routine optimization with a reasonable expectation of success because Coleman teaches that the patch thickness, sizing, etc. and suture conduit can be tailored to the desired parameters depending on the requirements of the tissue defect/repair.
Thus, the combined teachings of Coleman, Grafton, Mezger and Kim render the instant claims prima facie obvious.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Coleman (US 2017/0143551 A1, May 25, 2017, hereafter as “Coleman”), Grafton (US 2005/0192631 A1, Sep. 1, 2005, hereafter as “Grafton”), Mezger et al. (US 2013/0030526 A1, Jan. 31, 2013, hereafter as “Mezger”) and Kim et al. (KR 2017/0135677 A, Dec. 8, 2017, machine translation, hereafter as “Kim”), as applied to claims 6 and 15, and further in view of Whittaker et al. (US 2020/0000573 A1, Jan. 2, 2020, hereafter as “Whittaker”).
The invention is described above.
Coleman, Grafton, Mezger and Kim teach the elements discussed above.
Coleman, Grafton, Mezger and Kim are silent to the limitation, “wherein the crosslinked collagen-based covering comprises at least one cut along the at least one fold”.
Whittaker, in the analogous art of tissue repair, teaches tissue repair constructs including patches (abstract; [0005]). Whittaker teaches that the patch can have folding axes and cuts along the folding axes allowing for a preferential fold ([0437]-[0442]; Fig. 42A-42C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include cuts along a folding axis as suggested by Whittaker in the tissue repair patch of Coleman/Grafton/Mezger/Kim with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Whittaker teaches that cuts along a folding axis of a tissue repair patch allows for a preferential fold when the patch is in use and thereby improved handling.
Thus, the combined teachings of Coleman, Grafton, Mezger, Kim and Whittaker render the instant claim prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617