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 .
Election/Restrictions
Claims 35-37, 40-41, 46-47, 50, and 55-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/09/2026.
Response to Amendment
As of the reply filed 7/09/2026, claims 1, 6, 9-10, 22, 26, 35-37, 40-41, 46-47, 50, and 55-59 are pending. Claims 35-37, 40-41, 46-47, 50, and 55-59 are withdrawn. Claims 1, 35, and 55 have been amended.
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.
Claims 6, 10, and 26 are 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.
Regarding claims 6 and 10, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examination will continue under the assumption that the limitations which follow “optionally” are not required.
Claims 10 and 26 recite “or” or “and/or” at the ends of certain paragraphs, but not each paragraph. It is unclear which grouped elements of these claims are actually required given the alternative nature of these claims. It is recommended that the claims be amended to more clearly recite “and/or” or “or” at the end of each paragraph, or that the claims be otherwise amended to clearly list which limitations are alternative/optional versus which limitations are not. In particular, it is unclear whether the first limitation of claim 10 (“further comprising a set of teeth arranged along a length of the elongate portion”) is required. Examination will continue under the assumption that each new paragraph is an alternative limitation and that only one paragraph is required to be anticipated or obvious to read on the claim, and that the first limitation of claim 10 is not strictly required by the claim.
Claim Interpretation
Due to the alternative language in claim 22, the limitations of claim 26 are not explicitly required by the claims. As shown further below, Dean et al. anticipates conditional claim 22 by disclosing: “wherein the plurality of anchor members (108 in Figs. 6A-C) are arranged along a perimeter of the base plate (102, 108 are arranged along points along a perimeter of the base plate 102), or wherein the plurality of anchor members (108) are arranged to be spaced apart from a perimeter of the base plate (102, 108 are slightly within the outermost perimeter of the base plate 102)”, while claim 26 recites additional conditional limitations based off of the assumption that an alternate limitation of claim 22 was chosen.
Claim 26 is not rejected because it falls under an alternative condition of claim 22 which was not chosen by the Examiner in rejecting claim 22.
For the purposes of clarity, all non-chosen alternative conditions are marked via strikethrough in the following rejections.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6, 9, 10, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dean et al. (US PGPub 2009/0234386 A1).
With respect to claim 1, Dean et al. discloses a device for tissue repair (see Figs. 6A-B, abstract: “Various suture cleats are disclosed for repairing soft tissue injuries”) comprising[:]
a base plate (102) having a first surface and a second surface opposing the first surface (see top versus bottom of 102 in Fig. 6A);
an aperture (112) arranged on a portion of the base plate (102, aperture 112 is located on 110 which is on a portion of base plate 102), the aperture (112) configured to receive a suture (PP [0032]: “a distal connection end 112 (e.g., eyelet) for attachment to suture”);
a plurality of anchor members (108) extending from the first surface of the base plate (102, 108 extend from the top surface of 102 in Fig. 6A), each of the plurality of anchor members (108) having an end configured to penetrate a tissue (see 108 in tissue 20 in Figs. 6B-C)[;]
wherein each of the plurality of anchor members (108) is spaced apart from another anchor member (see spaces between the four anchor members 108 in Fig. 6A).
Regarding claim 2, Dean et al. further discloses a central shaft (110 in Fig. 6A) extending from the first surface of the base plate (102), the central shaft (110) having the aperture (112) arranged on the portion of the base plate (102)[;]
wherein a length of the central shaft (110) is shorter than, same as, or longer than a length of each of the plurality of anchor members (108, 110 is longer than 108 in Fig. 6B);
wherein the central shaft (110) comprises a partial circle, or a full circle (see 110 in Fig. 6A which has a circular perimeter);
wherein the central shaft (110) is pivotable with respect to the portion of the base plate (102, PP [0032]: “This post 110 can be rigid or flexible”, a flexible central shaft 110 is pivotable due to its bending); and/or
wherein a surface area of the central shaft (110) is greater than a surface area of the suture, along a longitudinal axis of the device (PP [0034]: “the post 110 has a larger diameter than the suture 50, the load of the suture 50's force may be more effectively distributed by the post 100's surface area acting on the adjacent tissue 20”).
Regarding claim 6, Dean et al. further discloses wherein the plurality of anchor members (108 in Fig. 6A) each comprise a rectangular frame extending from the base plate (102, see 108 in Fig. 6A which have four sides and a tapered pointed end, the four sides are rectangular), wherein a length of the rectangular frame (body of 108 in Fig. 6A) forms the end configured to penetrate the tissue (see 108 penetrating tissue 20 in Figs. 6B-C), optionally, further comprising, two rectangular frames joining each other at a breath to form a V-shape (see V-shape of pointed end of 108 in Fig. 6A, each rectangular face of the body of 108 is a frame which meet to form the V-shaped tapered end); and/or
wherein the plurality of anchor members (108) each comprise, a first portion extending from the first surface of the base plate (rectangular base portion of 108), [and] a second portion extending from an end of the first portion (tapered triangular tip of 108) and towards a central axis of the base plate (the tapered triangular tip of 108 extends in three dimensions including towards the central axis of the base plate as defined by 110).
Regarding claim 9, Dean et al. further discloses wherein the plurality of anchor members (108 in Fig. 6A) each comprise an elongate portion extending perpendicular from the base plate, or at an angle to the base plate (the elongate triangular tip portion of 108 tapers and extends at an angle relative to the base plate).
Regarding claim 10, Dean et al. further discloses
wherein the elongate portion (body of 108 in Figs. 6A-C) comprises a pointed tip which forms the end configured to penetrate the tissue (see pointed end of 108 penetrating tissue in Fgis. 6B-C);
wherein the elongate portion (body of 108 in Figs. 6A-C) comprises a beveled tip which forms the end configured to penetrate the tissue (see slanted pointed end of 108 in Fig. 6A penetrating tissue in Figs. 6B-C);
wherein the elongate portion (body of 108 in Figs. 6A-C) comprises an arrowhead tip which forms the end configured to penetrate the tissue (see pointed end of 108 which is triangular like an arrowhead)
wherein the elongate portion (body of 108) is configured to move towards a central axis of the base plate (102) in response to a force applied on the length of the elongate portion (108), and to move away from the central axis of the base plate (102) in response to release of the force (PP [0050]: “the cleats of the present disclosure may be made of any suitable material for medical purposes, including, but not limited to, a plastic material (e.g., polyethylene, polyetheretherketone, or delrin), a metal material, an elastomeric material, a radiolucent material, a bioabsorbable material, a non-bioabsorbable material, or a combination of these”, emphasis added, an elastomeric material is elastic and flexible and configured to bend and move in response to force as claimed); or
wherein an end of the elongate portion (108) is configured to crimp towards a central axis of the base plate (102), in response to a force applied against the end of the elongate portion (PP [0050]: “the cleats of the present disclosure may be made of any suitable material for medical purposes, including, but not limited to, a plastic material (e.g., polyethylene, polyetheretherketone, or delrin), a metal material, an elastomeric material, a radiolucent material, a bioabsorbable material, a non-bioabsorbable material, or a combination of these”, emphasis added, metal is configured to crimp in response to force).
Regarding claim 22, Deal et al. further discloses wherein the plurality of anchor members (108 in Figs. 6A-C) are arranged along a perimeter of the base plate (102, 108 are arranged along points along a perimeter of the base plate 102), or wherein the plurality of anchor members (108) are arranged to be spaced apart from a perimeter of the base plate (102, 108 are slightly within the outermost perimeter of the base plate 102);
wherein the base plate comprises102 in Figs. 6A-C is a full circle)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Euteneuer et al. (US Patent No. 8,668,718 B2) teaches a surgical staple (see Figs. 7A-C) comprising a body (104) and protrusions (120A-B) comprising a plurality of barbs (122A-B). There is no central base plate.
Schwartz et al. (US Patent No. 7,172,606 B2) teaches a surgical fixation device comprising a base plate (16 in Fig. 1), and a plurality of spokes (26, 28, 30, and 32) extending from the base plate (16).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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