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 .
Response for Election/Restrictions
Applicant’s election without traverse of Group I (claims 21-51) in the reply filed on 1/14/2026 is acknowledged. Applicant states that claims 21-51 read on the elected invention.
Election was made without traverse in the reply filed on 1/14/2026.
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 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 of this title, 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.
Claims 21-43 and 47-51 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (US Pub No. 2002/0077661).
Regarding claim 21, Saadat discloses a wound closure device (Figure 12) comprising: a plurality of base elements (91a-91c) arranged in a repeating pattern (Figure 12); a first anchor (92) extending from a first side of each base element of the plurality of base elements in a first direction for securing itself to a first layer of tissue along a wound within a body (Paragraph 0068).
Saadat fails to disclose a second anchor extending from a second side of each base element of the plurality of base elements in a second direction that is opposite to the first direction for securing itself within a second layer of tissue along the wound, such that the wound closure device is configured to hold the first and second layers of tissue against each other to close the wound.
Saadat alternative embodiment teaches (Figures 1-2) a wound closure device (20) comprising a first anchor (top 22) extending from a first side (top side) of each base element of the plurality of base elements in a first direction for securing itself to a first layer of tissue along a wound within a body (Paragraphs 0044 and 0056) and a second anchor (bottom 22) extending from a second side (bottom side) of each base element of the plurality of base elements in a second direction that is opposite to the first direction for securing itself within a second layer of tissue along the wound (Paragraphs 0044 and 0056), such that the wound closure device is configured to hold the first and second layers of tissue against each other to close the wound (Paragraphs 0044 and 0056). 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 device of Saadat to have included a second anchor extending from a second side of each base element of the plurality of base elements in a second direction that is opposite to the first direction for securing itself within a second layer of tissue along the wound, such that the wound closure device is configured to hold the first and second layers of tissue against each other to close the wound as taught by Saadat’s alternative embodiment, in order to permit closure of a wound in a timely, cosmetic and convenient manner by having two edges of the wound to be approximated and squeezed together onto the multiplicity of barbs so that tissue adhesion occurs and maintain the two edges of the wound firmly together (Saadat’s alternative embodiment, Paragraphs 0025 and 0057).
Regarding claim 22, Saadat modified by Saadat’s alternative embodiment further discloses wherein the wound closure device is configured to be disposed internal to the body between the first and second layers of tissue (Figure 4) (Paragraph 0057).
Regarding claim 23, Saadat modified by Saadat’s alternative embodiment further discloses wherein the wound closure device comprises a bidirectional wound closure device (Figures 1-2) (Paragraph 0044).
Regarding claim 24, Saadat modified by Saadat’s alternative embodiment further discloses wherein the wound closure device comprises a plurality of first anchors that extend from the first side of each base element of the plurality of base elements (Figures 1-2).
Regarding claim 25, Saadat modified by Saadat’s alternative embodiment further discloses wherein the wound closure device comprises a plurality of second anchors that extend from the second side of each base element of the plurality of base elements (Figures 1-2).
Regarding claim 26, Saadat modified by Saadat’s alternative embodiment further discloses wherein the repeating pattern comprises a two-dimensional array (Figure 12).
Regarding claim 27, Saadat modified by Saadat’s alternative embodiment further discloses wherein each base element of the plurality of base elements has an elongate shape (Figure 12).
Regarding claim 28, Saadat modified by Saadat’s alternative embodiment discloses the invention above except for wherein the elongate shape has an aspect ratio of greater than 1:4. 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 device of Saadat modified by Saadat’s alternative embodiment to have the elongate shape to have an aspect ratio of greater than 1:4 since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 29, Saadat modified by Saadat’s alternative embodiment further discloses wherein the repeating pattern comprises a one-dimensional array of the plurality of base elements arranged in a row (Figure 12).
Regarding claim 30, Saadat modified by Saadat’s alternative embodiment further discloses wherein the first and second anchors extend substantially perpendicularly with respect to the base element (Figure 2).
Regarding claim 31, Saadat modified by Saadat’s alternative embodiment further discloses wherein the wound closure device is configured to resist forces exerted on the first and second layers of tissue in directions parallel to a substantially planar arrangement of the plurality of base elements when the first and second anchors are secured to the first and second layers of tissue [Fully configured in doing this since Saadat modified by Saadat’s alternative embodiment discloses all of the structural elements in the same arrangement as claimed].
Regarding claim 32, Saadat modified by Saadat’s alternative embodiment further discloses wherein each base element of the plurality of base elements includes one or more holes formed therein (holes to where joints 93 enter as shown in Figure 12).
Regarding claim 33, Saadat modified by Saadat’s alternative embodiment further discloses a flexible substrate (93) to which the plurality of base elements are coupled in the repeating pattern (Figure 12).
Regarding claim 34, Saadat modified by Saadat’s alternative embodiment further discloses wherein the wound closure device is configured to hold the first and second layers of tissue against each other along the flexible substrate to close the wound [Fully configured in doing this since Saadat modified by Saadat’s alternative embodiment discloses all of the structural elements in the same arrangement as claimed].
Regarding claim 35, Saadat modified by Saadat’s alternative embodiment further discloses wherein the flexible substrate (93) comprises a plurality of loops of material (Figure 12).
Regarding claim 36, Saadat modified by Saadat’s alternative embodiment further discloses wherein each base element of the plurality of base elements includes a hole (holes to where joints 93 enter as shown in Figure 12) formed therein, and wherein a segment of the plurality of loops of material passes through the hole of the base element (clearly shown in Figure 12).
Regarding claim 37, Saadat modified by Saadat’s alternative embodiment further discloses wherein the hole is located along an edge of the base element (clearly shown in Figure 12).
Regarding claim 39, Saadat modified by Saadat’s alternative embodiment further discloses wherein loops of the plurality of loops of material are interlocked with each other (clearly shown in Figure 12).
Regarding claim 40, Saadat modified by Saadat’s alternative embodiment discloses the invention above including wherein the first anchor (25c) comprises a shaft and a head disposed at an end of the shaft (clearly shown in Figure 3) but fails to disclose wherein the first anchor has: a length in a range of 5 mm to 10 mm and a head width in a range of 0.3 mm to 0.5 mm; or a length in a range of 0.75 mm to 1.25 mm and a head width in a range of 0.1 mm to 0.15 mm; or a length in a range of 0.1 mm to 0.2 mm and a head width in a range of 0.1 mm to 0.15 mm; or a length in a range of 2.75 mm to 3.25 mm and a head width in a range of 0.1 mm to 0.15 mm. 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 device of Saadat modified by Saadat’s alternative embodiment to have the first anchor to have: a length in a range of 5 mm to 10 mm and a head width in a range of 0.3 mm to 0.5 mm; or a length in a range of 0.75 mm to 1.25 mm and a head width in a range of 0.1 mm to 0.15 mm; or a length in a range of 0.1 mm to 0.2 mm and a head width in a range of 0.1 mm to 0.15 mm; or a length in a range of 2.75 mm to 3.25 mm and a head width in a range of 0.1 mm to 0.15 mm since the only difference between the prior art and the claims is a recitation of relative ranges of the claimed device and a device having the claimed relative ranges would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 41, Saadat modified by Saadat’s alternative embodiment further discloses wherein the first anchor is made of a single material (Paragraph 0047).
Regarding claims 42 and 43, Saadat modified by Saadat’s alternative embodiment further discloses wherein the first anchor comprises a central core comprising a first material (metal as disclosed in Paragraph 0047) and an outer shell comprising a second material (coating as disclosed in Paragraph 0049) that differs from the first material and wherein the first material is harder than the second material (Paragraphs 0047 and 0049).
Regarding claim 47, Saadat modified by Saadat’s alternative embodiment further discloses wherein each of the plurality of base elements, the first anchor, and the second anchor comprises one or more polymers (Paragraph 0047).
Regarding claim 48, Saadat modified by Saadat’s alternative embodiment further discloses wherein the plurality of base elements has a different material formulation than at least one of the first anchor and the second anchor (Paragraph 0056).
Regarding claim 49, Saadat modified by Saadat’s alternative embodiment discloses the invention above except for wherein at least one of the plurality of base elements, the first anchor, and the second anchor comprises one or more of polydioxanone, polyglyconate, or polypropylene. 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 device of Saadat modified by Saadat’s alternative embodiment to have the at least one of the plurality of base elements, the first anchor, and the second anchor to comprise one or more of polydioxanone, polyglyconate, or polypropylene, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 50, Saadat modified by Saadat’s alternative embodiment further discloses wherein the first and second anchors comprise a resorbable material (Paragraph 0047).
Regarding claim 51, Saadat modified by Saadat’s alternative embodiment further discloses wherein at least one of the plurality of base elements, the first anchor, and the second anchor comprises a material that elutes a drug (Paragraph 0049).
Allowable Subject Matter
Claims 38 and 44-46 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose wherein each base element of the plurality of base elements includes at least two holes formed therein, and wherein at least two segments of the plurality of loops of material respectively pass through the at least two holes of the base element such that the base element couples at least two loops of the plurality of loops of material to each other (claim 38) and wherein the first anchor comprises: a shaft; and a head disposed at an end of the shaft, the head comprising: a sharp tip, a plurality of barbs extending away from the sharp tip and radially outward from the shaft, and a plurality of flexible support members respectively connected to the plurality of barbs and to the shaft to limit an extent to which the plurality of barbs can move radially outward from the shaft (claim 44).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771