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 to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 10 is objected to because of the following informalities: in lines 3 and 4, “first primary configuration” and ‘first secondary configuration” should read “. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The application as originally filed does not disclose a hollow needle (claim 7), or a needle having a lumen extending therethrough wherein the suture passes through the lumen of the needle (claim 8). It is noted that inserter (200) is not considered a needle as it is not described as a needle and is not disclosed as having a sharp or beveled tip. The application discloses needles 610 and 620. No lumen is disclosed in either needle, and the only detailed figures (17A, 17B) indicate that the anchors are received on a respective step of each needle, and the suture extends along an outside edge of each respective needle. Although the suture end (722) is shown exiting the proximal end of the housing, there is no disclosure of the suture extending through a lumen in the needle.
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) 1-6 and 9-11 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Storz-Irion et al. (US 2002/0156500). Storz-Irion discloses a suturing system (fig. 3) comprising an anchor assembly comprising a suture (5), a first anchor (distal-most 6) coupled to a distal portion of the suture and a second anchor (proximal-most 6) coupled to the suture proximal to the first anchor, and a suture inserter device (fig. 3). The suture inserter device comprises a housing (1) comprising a housing lumen (2) therethrough and a needle (7; considered needle as it punctures tissue; see fig. 5), wherein the first anchor couples to the needle (when positioned within channel 2 and needle is advanced into contact with the first anchor; see step 6 of fig. 5) wherein the needle is axially translatable within the housing lumen (see fig. 3, 5), and wherein the second anchor is positioned freely within the housing (i.e., second anchor is free to slide along suture 5, and is free to slide relative to the needle; this is similar to the instant invention, noting that the movement of the second anchor is necessarily limited by the housing itself as it is positioned within the housing according to the claim) and is couplable to the needle upon an axial translation of the needle or the second anchor within the housing lumen (i.e., when second anchor is advanced into the housing lumen 2, the needle can be advanced to couple to the second anchor in a manner similar to the first anchor).
Regarding claim 2, the first anchor comprises a plurality of first anchor inserts (wherein first anchor can be considered two distal-most elements 6), and wherein the second anchor comprises a plurality of second anchor inserts (wherein second anchor can be considered two elements 6 proximal of the two distal-most elements).
Regarding claim 3, at least two of the plurality of first anchor inserts are coupled, wherein at least two of the plurality of second anchor inserts are coupled, or both (noting all anchor inserts 6 are coupled to each other via suture 5).
Regarding claim 4, least a portion of the plurality of first anchor inserts, plurality of second anchor inserts, or both, have a shape comprising a sphere, a cylinder, a pyramid, a torus, a cone, a prism, or any combination thereof (anchor is a sphere, noting figure 3 and par. [0032]: “ball”).
Regarding claim 5, the housing, the needle, or a combination thereof comprise an indicator of the distance between a distal point of the housing lumen and a distal point of the needle. In particular, consider actuator (12), which provides a visual indication of this distance based on how far it has been depressed relative to 1 (i.e., distance is at maximum point when 12 has been fully depressed, which can be seen by the user).
Regarding claim 6, the suture inserter device further comprises a needle slider (see enlarged end of actuator 12) coupled to the needle (7) wherein the needle slider translates the needle within the housing between the primary (retracted) and secondary (advanced) configuration.
Regarding claim 9, the needle is solid, noting no lumen or other bore is disclosed.
Regarding claim 10, the suture inserter device comprises a needle inserter (actuator 12) coupled to the needle, wherein the needle inserter translates the needle within the housing lumen between the primary and secondary configurations.
Regarding claim 11, the first and second anchors are configured to transition from an insertion configuration that is substantially linear (when in 1) to a deployed configuration that is at least partially nonlinear. It is noted that this limitation is drawn to the intended use of the device. Since the anchors can be deployed into a nonlinear configuration (e.g., wherein each anchor comprises two anchor inserts 6 and the four anchor inserts are placed in a circular configuration), the prior art of Storz-Irion meets this limitation.
Claim(s) 1-8 and 10-11 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Riina et al. (US 2016/0015376). Riina discloses a suturing system (fig. 3) comprising an anchor assembly comprising a suture (20/180/330), a first anchor (distal-most 300) coupled to a distal portion of the suture and a second anchor (next anchor 320) coupled to the suture proximal to the first anchor, and a suture inserter device (fig. 3). The suture inserter device comprises a housing (110/120) comprising a housing lumen (220/116) therethrough and a needle (190; considered a needle due to its beveled end), wherein the first anchor couples to the needle (when positioned just distal of needle, first anchor rests against end of needle and may be pushed forward by needle; figs. 5-6) wherein the needle is axially translatable within the housing lumen (see fig. 4-6), and wherein the second anchor is positioned freely within the housing (i.e., second anchor is free to slide relative to the needle and the first housing lumen when suture is pulled; see esp. figs. 8-9; this is similar to the instant invention, noting that the movement of the second anchor is necessarily limited by the housing itself since the second anchor is positioned within the housing as claimed) and is couplable to the needle upon an axial translation of the needle or the second anchor within the housing lumen (e.g., movement from fig. 8, to 9, where anchor moves out of needle and then couples to distal end of the needle such that it can be pushed out of 120 via needle 190).
Regarding claims 7 and 8, the needle (190) is hollow and has a lumen (240) extending therethrough, wherein the suture passes through the lumen of the needle (as understood in view of figs.3-9).
Regarding claim 2, the first anchor comprises a plurality of first anchor inserts (wherein first anchor can be considered two distal-most elements 300; see fig. 9), and wherein the second anchor comprises a plurality of second anchor inserts (wherein second anchor can be considered two elements 300 proximal of the two distal-most elements; see fig. 9).
Regarding claim 3, at least two of the plurality of first anchor inserts are coupled, wherein at least two of the plurality of second anchor inserts are coupled, or both (noting all anchor inserts are coupled to each other via suture 330).
Regarding claim 4, least a portion of the plurality of first anchor inserts, plurality of second anchor inserts, or both, have a shape comprising a sphere, a cylinder, a pyramid, a torus, a cone, a prism, or any combination thereof (each anchor insert is a sphere, noting figure 1 and [0039]).
Regarding claim 5, the housing, the needle, or a combination thereof comprise an indicator of the distance between a distal point of the housing lumen and a distal point of the needle. In particular, consider sliding finger pad 150 (fig. 3), which provides a visual indication of this distance based on how far it has been slid in the distal direction relative to the housing (i.e., distance is at minimum point when 150 has been slid to its distalmost position, which can be seen by the user; since sliding finger pad 150 is described as the control necessary to operate the device as per [0052], it is understood to move the needle 190).
Regarding claim 6, the suture inserter device further comprises a needle slider (150) coupled to the needle (190) wherein the needle slider translates the needle within the housing between the primary (retracted) and secondary (advanced) configuration as understood by one of ordinary skill in the art in view of the sliding finger pad 150 being described as the control necessary to operate the device in par. [0052], and operation of the device includes “finger operated” movement of the needle 190 relative to the housing as per [0053]).
Regarding claim 10, the suture inserter device comprises a needle inserter (sliding finger pad 150) coupled to the needle, wherein the needle inserter translates the needle within the housing lumen between the primary and secondary configurations ([0052], [0053]).
Regarding claim 11, the first and second anchors are configured to transition from an insertion configuration that is substantially linear (when in needle and housing) to a deployed configuration that is at least partially nonlinear. It is noted that this limitation is drawn to the intended use of the device. Since the anchors can be deployed into a nonlinear configuration (e.g., wherein each anchor comprises two anchor inserts 320 and the four anchor inserts are placed in a circular configuration), the prior art of Storz-Irion meets this limitation.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Storz-Irion. Storz-Irion discloses the invention substantially as stated above except for each anchor having an outer width or diameter less than about 5mm. However, it would have been obvious to one of ordinary skill in the art to have sized each anchor of Storz-Irion to have an outer width or diameter of less than about 5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the anchors of both the prior art of Storz-Irion and the instant application serve to secure suture relative to tissue, and an anchor having the claimed size performs the same function of anchoring suture with respect to tissue as the prior art of Storz-Irion, and thus would not operate differently.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riina et al. Riina discloses the invention substantially as stated above except for each anchor having an outer width or diameter less than about 5mm. However, it would have been obvious to one of ordinary skill in the art to have sized each anchor of Riina to have an outer width or diameter of less than about 5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the anchors of both the prior art of Riina and the instant application serve to secure suture relative to tissue, and an anchor having the claimed size performs the same function of anchoring suture with respect to tissue as the prior art of Riina, and thus would not operate differently.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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KSH 1/8/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771