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
Applicant’s election without traverse of Group I (apparatus claims) in the reply filed on November 17, 2025 is acknowledged.
Claim Objections
Claims 2 and 27 are objected to because of the following informalities:
Claim 2 says “radially outboard” and it seems it should be –radially outward--.
Claim 21, lines 1-2, “wherein the spacer removably mounted to the proximal end of the drill shaft, and further comprising” does not seem to be proper grammar. Suggested to change it to –wherein the spacer is removably mounted to the proximal end of the drill shaft, and further comprising. Also, this line could be taken out because it is already in claim 7, so it is just a repeated limitation.
Claim 27 is dependent off itself, probably meant to be off claim 26.
Appropriate correction is required.
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 8-10 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.
Claim 8 requires the over grip (25) to be mounted intermediate the distal and proximal ends of the tube (10). The figures do not seem to support this. Note how the grip 25 is covering the tube at the proximal end and only the shaft 15 sticks beyond the top of the grip (Figs. 4 and 9). Claims 9 and 10 are dependent from claim 8.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7, 11-12, 21-22, and 24-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Figallo et al. (US 2019/0254683; “Figallo”).
Claim 1, Figallo discloses apparatus (Figs. 1-6; abstract) for effecting osteochondral restoration (Figs.1-6), the apparatus comprising: a tube (Fig. 1; 16) having a distal end (19), a proximal end (20) and a lumen (21; paragraphs [0060]-[0070]) extending therebetween; a drill shaft (Fig. 1; 2) rotatably disposed in the lumen of the tube (paragraphs [0053]-[0070]), the drill shaft comprising a distal end (3) and a proximal end (15); at least one cutting blade (9) disposed at the distal end of the drill shaft (Fig. 1); and a coring housing (region that 21 points towards) extending from the distal end of the tube (Fig. 1) and disposed around the at least one cutting blade (Fig. 1; paragraphs [0060]-[0070]), the coring housing terminating in a distal cutting surface (Fig. 1; while the end is somewhat dull it could still cut soft tissue with the right amount of force).
Claim 2, Figallo discloses the apparatus of claim 1, wherein the at least one cutting blade extends from the drill shaft radially outboard/outward to an inner surface (Fig. 4a) of the coring housing (Fig. 4a).
Claim 3, Figallo discloses the apparatus of claim 1, wherein the coring housing comprises a proximal base plate (Fig. 1; where 20 points) and a sidewall (wall that 16 points towards) disposed circumferentially about the perimeter of the base plate (Figs. 1, 4, and 4a).
Claim 4, Figallo discloses the apparatus of claim 3, wherein the proximal base plate comprises a center opening (Fig. 4a; near where 18 points) axially aligned with the lumen of the tube (Fig. 4a).
Claim 5, Figallo discloses the apparatus of claim 1, wherein the at least one cutting blade comprises a front cutting surface (Fig. 1; where 9 and 9a points there are a few angled cutting surfaces) disposed at an angle (Fig. 1) relative to a longitudinal axis (typical long axis running through the shaft) of the drill shaft (Fig. 1), and a rear surface (opposite surface to the front surface) disposed generally parallel to the longitudinal axis of the drill shaft (Fig. 1).
Claim 6, Figallo discloses the apparatus of claim 1, wherein the coring housing comprises at least one window (21) passing therethrough.
Claim 7, Figallo discloses the apparatus of claim 1 further comprising a spacer (Fig. 1; 22) removably mounted to the proximal end of the drill shaft (Fig. 1; paragraphs [0067]-[0079]), and further wherein the spacer prevents axial movement of the drill shaft relative to the tube when the spacer is mounted to the drill shaft (Fig. 1; paragraphs [0067]-[0079]).
Claim 11, Figallo discloses the apparatus of claim 1 further comprising a handle (Fig. 4; 10) mounted to the proximal end of the drill shaft (Fig. 4a).
Claim 12, Figallo discloses the apparatus of claim 11, wherein the proximal end of the drill shaft comprises at least one flat (Fig. 1; 15), the handle comprises a lumen (14) sized to receive the proximal end of the drill shaft (Figs. 1 and 4a), and further wherein the lumen of the handle comprises at least one flat sidewall (14 point towards the sidewall) for mating with the at least one flat of the drill shaft, such that rotation of the handle causes rotation of the drill shaft (Figs. 1 and 4a; paragraphs [0055]-[0059]).
Claim 21, Figallo discloses the apparatus of claim 7 wherein the spacer removably mounted to the proximal end of the drill shaft, and further comprising: a first configuration (Fig. 4a; when the spacer is connected) in which the spacer mounted to the drill shaft prevents the drill shaft from moving in a distal direction through the tube (Fig. 4a), and a second configuration (Fig. 4; without the spacer included) in which the spacer removed from the drill shaft allows the drill shaft to move in the distal direction through the tube (Fig. 4; paragraphs [0067]-[0079]).
Claim 22, Figallo discloses the apparatus of claim 21 wherein the second configuration allows the drill shaft to move in the distal direction through the tube with the drill shaft being rotated such that the at least one cutting blade cuts into the tissue bounded by the coring housing, whereby to core out a cavity in the tissue comprising the lesion (Figs. 4-4A; the spacer blocks 22 can be removed and the drill can go further down the tube and cut the tissue).
Claim 24, Figallo discloses the apparatus of claim 1 wherein the cutting surface is configured to (1) cut into the tissue around the perimeter of the lesion, and to (2) the tissue comprising a depth of cartilage through to bone without cutting into the bone (Figs. 4-4a; while the edge is not exactly sharp, it can still cut into soft tissue and softer cartilage, if the right amount of force is applied).
Claim 25, Figallo discloses the apparatus of claim 1 wherein the cutting surface is configured to (1) cut into the tissue around the perimeter of the lesion, and to (2) cut the tissue around the perimeter of the lesion includes cutting the tissue comprising a depth of cartilage without cutting through the cartilage to bone (Figs. 4-4a; while the edge is not exactly sharp, it can still cut into soft tissue, if the right amount of force is applied).
Claim 26, Figallo discloses the apparatus of claim 1 further comprising a radially-extending stop (Fig. 4a; 22) mounted at a selected point along the drill shaft (Fig. 4a) in a configuration to prevent the at least one cutting blade from moving beyond the distal cutting surface of the coring housing (Fig. 4a; paragraphs [0067]-[0079]).
Claim 27, Figallo discloses the apparatus of claim 26 wherein the radially-extending stop is configured to allow (1) advancement of the distal cutting surface to a given depth in the tissue with an application of a distally-directed force to the distal cutting surface, and (2) a coring out of a cavity in the tissue proximal of, or to, a given depth of the distal cutting surface as limited by the radially-extending stop (Figs. 1-4a; paragraphs [0067]-[0079]).
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.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Figallo et al. (US 2019/0254683; “Figallo”), in view of Stone (US 5921987), in further view of Bradica et al. (US 2006/0173476; “Bradica”).
Claim 8, Figallo discloses the apparatus of claim 1.
However, Figallo does not disclose an over grip mounted to the tube.
Stone teaches an over grip (Fig. 1; 26) mounted to a tube (12) located at the proximal end of the tube (Fig. 1).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include an over grip, as taught by Stone, to the apparatus of Figallo, in order to allow a surgeon a gripping location to help rotate and manipulate the device (col. 3, lines 30-37).
While the over grip is not entirely between the proximal and distal ends of the tube, it would have been obvious to one having ordinary skill in the art at the time the invention was made to put the grip a little further down the shaft of the tube, since it has been held that rearranging parts of an invention involves only routine skill in the art.
Furthermore, Bradica teaches putting the gripping portion (Fig. 1; 16) intermediate the distal and proximal ends of their tube (Fig. 1).
Claim 9, Figallo in view of Stone and Bradica disclose the apparatus of claim 8, wherein the drill shaft comprises a stop (Fig. 4; 15) formed on the proximal end of the drill shaft (Fig. 4), the stop being (i) spaced from the over grip (over grip is on tube 16 once combination is made, so they are spaced apart) when the drill shaft is in a first, proximal axial position (Figs. 4-4a), or (ii) in contact with the over grip so as to prevent further distal axial movement of the drill shaft relative to the tube when the drill shaft is in a second, distal axial position (part of an “or” statement so this (ii) doesn’t matter since the (i) is taught).
Claim 10, Figallo in view of Stone and Bradica disclose the apparatus of claim 9, wherein when the drill shaft is in the second, distal axial position, no portion of the at least one cutting blade extends distally beyond a plane defined by the cutting surface disposed normal to a longitudinal axis of the drill shaft (same as above part (i) is taught).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Figallo et al. (US 2019/0254683; “Figallo”), in view of Bobic et al. (US 5919196; “Bobic”).
Claim 23, Figallo discloses the apparatus of claim 1.
However, Figallo does not disclose the cutting surface being capable of cutting into bone.
Bobic teaches a cutting surface (Fig. 1; 8) that is configured to (1) cut into the tissue around the perimeter of the lesion, and to (2) cut the tissue comprising both cartilage and bone (Fig. 1; col. 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the end of the tube of Figallo, to include a cutting surface that can cut into bone, as taught by Bobic, in order to help the device cut into the bone to help remove material (cols. 4-5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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/Zade Coley/Primary Examiner, Art Unit 3775