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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/10/2026 has been entered.
Response to Arguments
The amendments to the claims have overcome the previously presented 35 USC 112a rejection of claims 7 and 8. However, a new 35 USC 112a rejection of claims 1-12 is presented below in view of the amendments to the claims.
Applicant’s arguments with respect to the claim amendments overcoming the previously presented 35 US 102a1 and 103 rejections over Riina have been fully considered and are persuasive.
Applicant’s arguments with respect to the claim amendments overcoming the previously presented 35 US 102a1 and 103 rejections over Storz-Irion have been fully considered and not are persuasive. Applicant asserts that Storz-Irion fails to disclose a housing lumen housing the suture, first anchor, second anchor, and needle. The examine respectfully disagrees. The examiner relies on the embodiment shown in fig. 3 of Storz-Irion. The housing lumen can be considered channel 2 (wherein 2 is the channel in which sleeve 11 is inserted in fig. 3) and channel 16 of housing (1), noting channel 16 is continuous with channel 2 and merely forms an end portion of the lumen (see fig. 3). Alternatively, the lumen can be considered only working channel 16 (area indicated in fig. 3). As shown in fig. 5, each of the needle (7), first anchor (distal-most anchor 6), and suture (5) are positioned within the housing lumen (at least channel 16 of the housing lumen 2/16) at some point. For example, the suture is positioned within the housing lumen at steps 2-7, the first anchor is positioned within the housing lumen in at least step 5, and the needle is positioned within the housing lumen in steps 1-7 (in portion 16 in at least step 3 and 6). The movements shown in fig. 5 (steps 1-7) are repeated with the next anchor, considered the claimed second anchor (ss understood in view of [0024]), and thus the second anchor is also positioned within the housing lumen (at step 5 when steps 1-7 are repeated). Note that the claim does not require that the suture, first anchor, second anchor, and needle are housed simultaneously in the housing lumen.
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 1-12 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. Claim 1 includes, in combination with the remaining limitations of the claim, the limitation of the suture inserter device comprising a housing lumen therethrough housing the suture, first anchor, second anchor, and a needle, which is not supported in the application as originally filed. There is no disclosure of a housing having a housing lumen therethrough (understood to be one lumen in view of the wording “a housing lumen”) that houses the suture, the first anchor, the second anchor, and the needle.
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.
Claim 7 is 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 7 recites “the first and second anchor inserts” which lacks clear antecedent basis, noting that only first and second anchors have been previously recited. As best understood “the first and second anchor inserts” should read “the first and second anchors ” and has been thus treated for purposes of claim interpretation.
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 (2/16) therethrough housing the suture, first anchor, second anchor, and a needle (7; considered needle as it punctures tissue; see fig. 5) configured to pierce tissue of a patient (note: each of the suture, first anchor, second anchor, and needle are housed within the housing lumen at some point during the procedure shown in fig. 5, which is repeated with the second anchor as understood in view of [0024]; the claim does not require that all four of the recited elements are simultaneously housed within the housing), wherein the first anchor couples to the needle (when positioned within channel 2/16 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 lumen (i.e., second anchor is free to slide along suture 5 into the housing lumen when it is not blocked by the needle, 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 2/16, 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 and 5-10 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Hart et al. (US 2013/0096613). Hart discloses a suturing system comprising an anchor assembly comprising a suture (14), a first anchor (12) coupled to a distal portion of the suture and a second anchor (12’) coupled to the suture proximal of the first anchor, and a suture inserter device (50: see figs. 13-15, 19,20). The suture inserter device comprises a housing (58; fig. 13) comprising a housing lumen therethrough housing the suture, first anchor, second anchor, and a needle configured to pierce tissue of a patient (noting knob 78 can be used to retract needle into housing; [0096], [0098]), wherein the first anchor couples to the needle (see figs. 14, 15), where the needle is axially translatable within the housing lumen between a primary configuration and a secondary configuration (retracted and extended configurations of Hart), wherein the second anchor is positioned freely within the housing lumen ([0097], noting housing lumen includes slot or recess that releasably receives second anchor 12’/112’; considered “freely” within housing lumen as it is free to slide from the housing lumen into the interior passage of needle after first anchor is delivered and needle is retracted as per [0098]) and is coupleable to the needle upon an axial translation of the needle or the second anchor within the housing lumen ([0098]).
Regarding claim 5, the housing, the needle, or a combination thereof, comprise an indicator (calibration bands 70) of the distance between a distal point of the housing lumen and a distal point of the needle ([0096]).
Regarding claim 6, the suture inserter device further comprises a needle slider (78) coupled to the needle, wherein the needle slider translates the needle within the housing lumen between the primary configuration and the secondary configuration.
Regarding claim 7, the needle comprises a distal end having a step (note sloped surface, which is considered a step between the luminal wall and the flat surface that terminate at tip 64 in fig. 15, noting change in wall thickness caused by the step) configured to receive one or more of the first and second anchors.
Regarding claim 8, the first anchor and the second anchor each comprise a cavity (hole 26) allowing the suture to pass therethrough to create a one-way suture lock (see figs. 3, 4; [0088]).
Regarding claim 9, the needle is solid. Consider the embodiment shown in fig. 20 of Hart, wherein the first anchor 112 is loaded over a solid needle (154; fig. 19, 20).
Regarding claim 10, the suture inserter device further comprises a needle inserter (78) coupled to the needle, wherein the needle inserter translates the needle within the housing lumen between the primary configuration and secondary configuration ([0096]).
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 Hart. Hart 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 Hart 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 Hart 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 Hart, and thus would not operate differently.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KSH 7/23/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
Prosecution Insights