DETAILED ACTION
In view of the Appeal Brief filed on 05/26/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below.
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 .
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.
Response to Arguments
Applicant’s arguments, see Appeal Brief Filed, filed 05/26/2026, with respect to the rejection(s) of claim 1 under US 5601558 A (hereafter --Torrie--) in view of US 10561411 B1 (hereafter --Cole--) 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 Therefore, the rejection has been withdrawn.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 in view of US 20060235413 A1 (hereafter –Denham--).
Claim Objections
Claim 1 is objected to because of the following informalities:
It is unclear whether “a periosteal tissue suspension suture” is the same suture as “facilitating the holding of a suture” or an additional suture. The Examiner suggests amending the claim to instead have “a periosteal suture” followed by “the periosteal suture”.
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.
Claims 1-3, 7-9, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060235413 A1 (hereafter –Denham--).
Regarding Claim 1, Denham discloses a tissue suspension implant (10), comprising: an implant head (32); a shaft (34) extending down from the implant head comprising a through hole (22), the through hole positioned entirely below the implant head (see annotated figure below), the shaft comprising a diameter that is smaller than a diameter of the implant head (see annotated head, shaft, and through hole in Figures 1-3 below); and a positioner pin (48) extending up from the implant head for use in positioning the tissue suspension implant (see paragraph [0066]), the positioner pin configured to be broken off from the implant head (see Figure 4C below, see also paragraph [0065]); wherein the tissue suspension implant is made out of a material that compresses when a diameter of the shaft is squeezed (see paragraph [0074] denoting that the sleeve 20 has expanding components, being made of a material that can also be pressed, and also that the sleeve portion goes around the shaft and therefore around the through hole, squeezing the shaft and facilitating a lock of the suture into the device), thereby facilitating holding of a suture in the through hole, wherein the through hole is configured to receive and retain a periosteal tissue suspension suture (see annotated suture 30 in Figure 3A below).
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The limitation “wherein the tissue suspension implant is a periosteal tissue suspension implant” is treated as intended use and has been considered but deemed not to impose any structural difference between the claimed invention and Denham’s modified device. Denham’s device is structured as claimed and is capable of being used as a periosteal tissue suspension implant as claimed since the implant device of Denham as modified is able to be inserted into periosteal tissue as it is able to be implanted into the human body.
Regarding Claim 2, Denham discloses the implant of claim 1, wherein the implant head comprises a domed shape (see annotated head in Figure 1 above).
Regarding Claim 3, Denham discloses the implant of claim 1, wherein the implant head has tapered head edges (see annotated tapered edges in Figure 3A above).
Regarding Claim 7, Denham discloses the implant of claim 1, wherein the shaft comprises a smooth shaft with a constant diameter (see annotated shaft in Figure 1 above).
Regarding Claim 8, Denham discloses the implant of claim 1.
The limitation “wherein the tissue suspension implant is configured for use with a drill bit having a drill bit end that forms an opening in a patient's bone that is a fraction of a millimeter smaller than the diameter of the shaft” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The implant device of Denham is configured for the use as claimed (being used with a drill bit that forms and opening in a patient’s bone) since Denham discloses drilling a hole into bone (see paragraphs [0061] and [0062] in order to implant the suture anchor into a “pre-drilled hole” and since the specification specifically discloses inserting the implant into bone (see Abstract).
Regarding Claim 9, Denham discloses the implant of claim 1, wherein the through hole comprises protrusion walls located around an opening and an exit of the through hole (the protrusion walls being the inside of sleeve 20, in which the sleeve surrounds the opening and exit of the through hole in the second position as described in paragraph [0074]).
Regarding Claim 12, Denham discloses the implant of claim 1, wherein the positioner pin is configured to be broken off cleanly from the implant head (see Figure 4C above, see also paragraph [0065]).
Regarding Claim 14, Denham discloses the implant of claim 1, wherein the through hole comprises a through hole wall wherein squeezing the shaft of the implant causes a compression along the wall of the through hole to hold the suture in the through hole (see annotated through hole wall being the rim of the through hole on the shaft, the “through hole wall” being squeezed by the inside of the sleeve 20 in the second position thereby holding the suture in place as described in paragraph [0074]).
Claims 1-3, 6, 8, 9, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060235413 A1 (hereafter –Denham--).
Regarding Claim 1, Denham discloses a tissue suspension implant (10), comprising: an implant head (32); a shaft (34, 20) extending down from the implant head comprising a through hole (see annotated through hole in Figure 1 below, the through hole being the lumen within sleeve 20 that component 18 is received in), the through hole positioned entirely below the implant head, the shaft comprising a diameter that is smaller than a diameter of the implant head (see annotated head, shaft, and through hole in Figures 1-3 below, a portion of the shaft 34 having a smaller diameter than the head); and a positioner pin (48) extending up from the implant head for use in positioning the tissue suspension implant (see paragraph [0066]), the positioner pin configured to be broken off from the implant head (see Figure 4C below, see also paragraph [0065]); wherein the tissue suspension implant is made out of a material that compresses when a diameter of the shaft is squeezed (see paragraph [0074] denoting that the sleeve 20 has expanding components, being made of a material that can also be pressed, and also that the sleeve portion goes around the component 34 and suture 30, therefore when the shaft is inserted into the pre-drilled hole and the shaft is compressed, the device facilitates a lock of the suture into the device, see also Figure 1 showing the suture goes within the through hole), thereby facilitating holding of a suture in the through hole, wherein the through hole is configured to receive and retain a periosteal tissue suspension suture (see Figure 1 showing the suture goes within the through hole).
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The limitation “wherein the tissue suspension implant is a periosteal tissue suspension implant” is treated as intended use and has been considered but deemed not to impose any structural difference between the claimed invention and Denham’s modified device. Denham’s device is structured as claimed and is capable of being used as a periosteal tissue suspension implant as claimed since the implant device of Denham as modified is able to be inserted into periosteal tissue as it is able to be implanted into the human body.
Regarding Claim 2, Denham discloses the implant of claim 1, wherein the implant head comprises a domed shape (see annotated head in Figure 1 above).
Regarding Claim 3, Denham discloses the implant of claim 1, wherein the implant head has tapered head edges (see annotated tapered edges in Figure 3A above).
Regarding Claim 6, Denham discloses the implant of claim 1, wherein the shaft comprises a split shaft comprising two side legs (72, see annotated two side legs in Figure 3 above, see also paragraph [0070]).
Regarding Claim 8, Denham discloses the implant of claim 1.
The limitation “wherein the tissue suspension implant is configured for use with a drill bit having a drill bit end that forms an opening in a patient's bone that is a fraction of a millimeter smaller than the diameter of the shaft” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. The implant device of Denham is configured for the use claimed (being used with a drill bit that forms and opening in a patient’s bone) since Denham discloses drilling a hole into bone (see paragraphs [0061] and [0062] in order to implant the suture anchor into a “pre-drilled hole” and since the specification specifically discloses inserting the implant into bone (see Abstract).
Regarding Claim 9, Denham discloses the implant of claim 1, wherein the through hole comprises protrusion walls located around an opening and an exit of the through hole (see annotated protrusion walls, exit, and opening of through hole in Figure 1 above).
Regarding Claim 12, Denham discloses the implant of claim 1, wherein the positioner pin is configured to be broken off cleanly from the implant head (see Figure 4C above, see also paragraph [0065]).
Regarding Claim 14, Denham discloses the implant of claim 1, wherein the through hole comprises a through hole wall wherein squeezing the shaft of the implant causes a compression along the wall of the through hole to hold the suture in the through hole (the through hole wall being the inside of the through hole, which squeezing the shaft would cause compression along the wall and would hold the suture tight and in place, as described in paragraph [0074]).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 4, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060235413 A1 (hereafter –Denham--) as applied to claim 1 above, and further in view of US 10561411 B1 (hereafter --Cole--).
Regarding Claim 4, Denham discloses the implant of claim 1.
Denham fails to disclose wherein the shaft has a diameter that is about 2.0-3.5 mm.
However, Cole discloses a tissue suspension implant, comprising: an implant head; a shaft extending down from the implant head, the shaft comprising a diameter that is smaller than a diameter of the implant head (see annotated head and shaft in Figure 16); and a positioner pin extending up from the implant head for use in positioning the tissue suspension implant (see annotated positioner pin in Figure 16 below, see also column 9, lines 52-58), the positioner pin configured to be broken off from the implant head (see column 9, lines 52-58). Cole teaches wherein the shaft has a diameter that is about 3 to 12 mm (see column 9, lines 1-2), a range that overlaps with the claimed range of about 2.0-2.5 mm, in order to have an overall size which is generally small enough to be implanted inside a human body (see column 8, lines 65-68 to column 9, lines 1-2). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the diameter of the shaft of Denham be 3 mm to 12 mm. Doing so would enable the implant to have an overall size which is generally small enough to be implanted inside a human body (see column 8, lines 65-68 to column 9, lines 1-2).
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Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of the shaft of Denham from 3 to 12 mm to about 2.0-3.5 mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [0023] indicating the angle “may” be within the claimed range).
Regarding Claim 5, Denham discloses the implant of claim 1.
Denham fails to disclose wherein the shaft has a diameter that is about 3.04 mm.
Cole teaches wherein the shaft has a diameter that is about 3 to 12 mm (see column 9, lines 1-2), a range that overlaps with the claimed value of about 3.04 mm, in order to have an overall size which is generally small enough to be implanted inside a human body (see column 8, lines 65-68 to column 9, lines 1-2). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the diameter of the shaft of the primary embodiment of Cole to be 3 mm to 12 mm. Doing so would enable the implant to have an overall size which is generally small enough to be implanted inside a human body (see column 8, lines 65-68 to column 9, lines 1-2). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the shaft of Denham from 3 to 12 mm to about 3.04 mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [0023] indicating the angle “may” be this value, but also could be within 2.0-3.5 mm).
Regarding Claim 13, Denham discloses the implant of claim 1.
Denham fails to disclose wherein the through hole comprises a diameter between 0.25 mm and 0.75 mm.
Cole teaches wherein the through hole (inside of 2016) has a diameter that is “slightly larger” than the diameter of the suture, which is around tens of microns in diameter to multiple millimeters (see column 14, lines 48-50 denoting there is a predetermined interference fit between the inside diameter D5 of the collet 2016 (inside of through hole in Figure 33 above) and the outside diameter D1 of the tensile member 10, see also column 7 lines 58-62 denoting D1 can range from tens of microns in diameter to multiple millimeters), a range that overlaps with the claimed value of 0.25 mm and 0.75 mm, in order to be sized to receive a suture (tensile member 10) (see column 13, lines 37-38). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the diameter of the through hole of Denham be “slightly larger” than the diameter of a typical suture, which is around tens of microns in diameter to multiple millimeters. Doing so would enable the through hole to be sized to receive a suture (see column 13, lines 37-38).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the through hole of Denham have a diameter to be from “slightly larger” than the diameter of a typical suture, which is around tens of microns in diameter to multiple millimeters to about 0.25 to 0.75 mm as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see [0021] indicating the angle “may” be within this range).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights