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 to Arguments
Applicant argues in the response filed 02/25/2026 that the claim amendments would overcome the previous drawing objections and 112 rejections because there is“support found throughout the specifical and figures as filed, for example paragraphs 109-119 and figure 14”. However the examiner disagrees. There does not seem to be specific support for facilitating formation of the knot of the first anchor by having the second anchor contacting the first anchor. The applicant does not specifically highlight where the support is, just cites multiple paragraphs and figures. Figure 14-3 shows the first anchor extending beyond a proximal edge of the needle distal end but the second anchor is not contacting the first anchor. Figure 14-4 seems to show the formation of knot of the first anchor, but the second anchor would not be known to have contacted the first anchor based on the figure 14-4. Paragraph 117 supports pulling the suture tails to form the knot and that the pusher may be pressed against the first anchor while tension is applied (in a single suture anchor delivery embodiment). Paragraph 116 supports having the second anchor push the first anchor to cause the first anchor to exit the lumen, but there does not seem to be specific support for the second anchor to contact the first anchor to facilitate the knot formation of the first anchor. Therefore, the drawing objections and 112 rejections are maintained, as argued, below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “second anchor configured to … maintain contact with the first suture anchor beyond the proximal edge of the distal end of the needle to facilitate the first suture anchor forming the knot” and “ the second suture anchor is configured to press against the first suture anchor beyond the proximal edge of the distal end in response to pulling force at the one or more suture tails to cause the first suture anchor to form the knot” must be shown or the feature(s) canceled from the claim(s). The figures seem to show the pusher maintaining contact with a singular suture anchor which helps the anchor form the knot, but the figures do not show a second anchor contacting a first anchor, and how maintaining contact between the suture anchors and the first suture anchor can help to form the knot of the first suture anchor. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 5, 6, 21-32, 34-38 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.
Each of the independent claims 1 (lines 10-13) and 32 (lines 11-15), state “second anchor configured to … maintain contact with the first suture anchor while the second suture anchor is extended at least partially beyond the proximal edge of the distal end of the needle to facilitate the first suture anchor forming the knot”. Independent claim 26 claims (lines 11-15) “the second anchor configured to … maintain force on the on the first suture anchor while the second suture anchor is extended at least partially beyond the proximal edge of the distal end of the needle to press the second suture anchor against the first suture anchor to cause the first suture anchor to form the knot. Dependent claim 5 claims (lines 2-5) “the second anchor is configured to press against the first suture anchor beyond the proximal edge of the distal end in response to puling force at the one or more suture tails to cause the first suture anchor to form the knot”.
There does not seem to be support for the limitations with respect to the second anchor contacting/pressing the first anchor to facilitate forming a knot in the first anchor. The applicant states there is support in figure 14, paragraph 109-119 in the application as originally filed. However the figures do not show second anchor contacting the first anchor to facilitate the first suture anchor forming the knot and/or how the contact between the anchor can help facilitate the knot formation. Figure 14-4 seems to show the pusher contacting a first suture anchor which can help to form the knot, but figure 14-4 in the two suture anchor embodiment does not show the second anchor maintaining contact with the first suture anchor to facilitate forming the knot. It can be known that the second anchor can translate force from the pusher to the first anchor to the push the first anchor beyond a proximal edge of the distal end of the needle. However, there is no positive support of the second anchor contacting the first anchor to facilitate the knot formation. Paragraph 117 states that “when there is only one suture anchor delivered by the needle, the pusher may be pressed against and/or may be in contact with the first suture anchor while tension is applied to the first suture anchor”. However, the paragraphs do not state that the second suture anchor can be pressed against the first suture anchor, which will facilitate forming the knot. It would not be inherent that there will need to be contact between the first and second suture anchors to facilitate the knot formation of the first suture anchor since the valve leaflet can provide the support for the tension that is applied the first suture anchor to form the knot. The anchor can be pulled against the tissue which can facilitate the knot formation. Tissue can be used as a counter force for the anchor to form the knot. Pulling the suture tails will help facilitate the knot formation but the anchors touching to facilitate the knot formation is not known. Further, it may not be desirable for the first and second sutures anchors to contact while a knot is formed. Contact between the anchors can tangle the sutures tails extending proximally from the anchors. Since the specification does not provide specific support for the limitation of “second anchor configured to maintain contact (or a pressing force) with the first suture anchor to facilitate the first suture anchor forming the knot” and it would not be inherent, the limitation is considered to be new matter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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 on (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.
/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
Prosecution Insights