Prosecution Insights
Last updated: April 19, 2026
Application No. 17/656,840

VALVE REPAIR USING TISSUE ANCHORS

Final Rejection §102§103§112
Filed
Mar 28, 2022
Examiner
HIGHLAND, RACHEL S
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
2 (Final)
67%
Grant Probability
Favorable
3-4
OA Rounds
3y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allow Rate
234 granted / 348 resolved
-2.8% vs TC avg
Strong +36% interview lift
Without
With
+36.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
21 currently pending
Career history
369
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
40.9%
+0.9% vs TC avg
§102
28.8%
-11.2% vs TC avg
§112
20.8%
-19.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 348 resolved cases

Office Action

§102 §103 §112
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 Amendment Claims 1 and 5-23 are pending in the application. Claims 11-16 are withdrawn. Claims 21-23 are newly added. Claims 2-4 have been canceled. Claims 1 and 17-20 have been amended. Claims 1, 5-10, and 17-23 are rejected. 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 6, 9, and 22 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. Regarding claim 6, the newly added amendments to claim 1 upon which claim 6 depends have altered the scope such that claim 6 is no longer supported by the specification. Specifically, applicant’s disclosure does not provide support for a needle with a beveled tip portion and an angled outlet opening where the angled outlet opening is an opening in a sidewall of the shaft portion of the needle. Applicant has support for either a needle with a beveled tip and angled outlet opening (as seen in Figs. 40A&40B) OR an opening in the sidewall of the shaft portion of the needle (as seen in Figs. 36-38). Applicant has not disclosed an embodiment with an angled tip AND an opening in the side wall as now required by claim 6. Appropriate action is required. Regarding claim 9, the newly added amendments to claim 1 upon which claim 9 depends have altered the scope such that claim 9 is no longer supported by the specification. Specifically, applicant’s disclosure does not provide support for a retractable puncturing feature configured to extend from the tip portion of the needle. Applicant does have support for the needle being retractable from a shaft (See Figs. 40A & 40B), paragraph [0201] as published. Regarding claim 22, the specification does not provide support for the newly added limitation “wherein the suture passes through suture apertures of each of the plurality of tissue anchors in a common transverse direction”. For the purposes of examination, as can best be understood from the specification, the common transverse direction is a description of the suture opening in each of the anchors, and the suture is threaded through the suture opening in each anchor. Claim Rejections - 35 USC § 102 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. 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, 5, 6, 7, 9, and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone et al (US PG Pub 2006/0190042). PNG media_image1.png 433 692 media_image1.png Greyscale Regarding claim 1, Stone teaches a tissue anchor delivery device (150) (See Figs. 18-24 and 29-33) comprising: a needle (156) including a hollow shaft portion (156 – See Figs. 29-30), a beveled1 tip portion (160), and an angled outlet opening (158 – see Figs. 30 and 32; paragraphs [0054] and [0060]); a plurality of tissue anchors (102 an 102’) (See, for example, Figs. 17 and 22) disposed within the shaft portion of the needle (See Figs. 19, 22, 23, 29; paragraphs [0050]-[0055]), each of the plurality of tissue anchors (102/102’) including: a main body portion (120) that is elongate in a longitudinal dimension (See Fig. 2) and forms a flat tissue-contact surface2 (126) and a suture-holding surface opposite the tissue- contact surface (See Fig. 3); and a tab (128) that projects transversely from the suture-holding surface of the main body portion, the tab (128) including a suture aperture(130) having an axis oriented in a perpendicular direction perpendicular to the longitudinal dimension (See Figs 2 & 3; paragraphs [0050]-[0051]); and a suture (106) running through the suture aperture (130) of the tab of each of the plurality of tissue anchors in the perpendicular direction within the shaft portion of the needle (See Figs. 19, 22, 23, 25, and 29; paragraphs [0050]-[0054]). Regarding claim 5, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches a pusher device (162) disposed at least partially within the shaft portion (156) of the needle and configured to move the plurality of tissue anchors within the shaft portion, wherein the suture is disposed at least partially within a lumen of the pusher device. (See paragraphs [0054] and [0057]). Regarding claim 6, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches the outlet opening (158) is an opening in a sidewall of the shaft portion of the needle (note the opening includes the slot in the side wall – See Fig. 19; paragraphs [0053]-[0055] and [0060]). Regarding claim 7, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches the outlet opening is associated with the tip portion (160) of the needle (See Figs. 19, 22, 23, 29; paragraphs [0050]-[0055]). Regarding claim 9, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches a retractable puncturing feature3 configured to extend from the tip portion (160) of the needle. (note the tubular sleeve 170 can extend and cover the tip (160) of the needle. This is deemed sufficient to encompass a “retractable puncturing feature”) (See paragraph [0055]) Regarding claim 21, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches wherein bunched lengths of suture (note additional lengths of suture 106 in Fig. 19) are collected in open spaces between tabs of adjacent ones of the plurality of tissue anchors, the open spaces being partially bounded by the suture-holding surfaces of the adjacent ones of the plurality of tissue anchors. (See Fig. 19, note the suture is open space between the anchors (102/102’) what are partially bounded by the surfaces of the anchors including directing grooves 132 – See also paragraph [0050]). Regarding claim 22, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches the suture (106) passes through the suture apertures (130) of each of the plurality of tissue anchors (102/102’) in a common transverse direction. (it is noted that the suture aperture of each anchor shares the same transverse positioning relative to the elongated anchor body. It is additionally noted that the suture extends through the suture aperture (130) of each anchor. (See Figs. 19 and 39-40; paragraph [0067]). Regarding claim 23, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches needle further includes a protruding member (166) disposed on an interior wall of the hollow shaft portion at a position longitudinally overlapping with the angled outlet opening (See Figs. 19-23), the protruding member (166) being configured to4 interfere with distal movement of the tabs of the plurality of tissue anchors to prevent pre-deployment exit through the angled outlet opening and to cause rotation of the plurality of tissue anchors when exiting the outlet opening; and the protruding member is disposed on an interior wall of the needle that is circumferentially opposite the outlet opening. (See paragraphs [0054]-[0055] and [0057]). 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 (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. 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 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al (US PG Pub 2006/0190042) in view of previously cited Keidar et al (US PG Pub 2017/0304050). Regarding claim 8, Stone teaches the tissue anchor delivery device as set forth in claim 1 above but does not explicitly teach a suction device configured to hold the tissue anchor delivery device to a heart valve annulus. Keidar teaches an analogous tissue anchor delivery device featuring a needle (801) including a hollow shaft portion (703), a tip portion (802), and an outlet opening (803) (See Figs. 8A & 8B); a plurality of tissue anchors (503, 504, 505) disposed within the shaft portion of the needle (See Fig. 5; paragraphs [0059] and [0062]); and a suture (507) coupled to each of the plurality of tissue anchors and disposed at least partially within the shaft portion of the needle (See Fig. 5; paragraphs [0059]-[0062]) and a suction device configured5 to hold the tissue anchor delivery device to a heart valve annulus. (See paragraphs [0067] and [0077] which disclose a suction cup 1904 to assist in holding target tissue during deployment). It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate a suction device as taught by Keidar into the tissue anchor delivery device as taught by Stone so as to allow the device to be securely and reliably positioned at the desired deployment location. Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Stone et al (US PG Pub 2006/0190042). Regarding claim 10, Stone teaches the tissue anchor delivery device as set forth in claim 1 above and further teaches the tip portion is a separate component6 from the shaft portion; and the tip portion is attached to an end of the shaft portion. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the tip be a separate component from the shaft since it has been held that making an article separable is within the scope of ordinary skill in the art. See MPEP §2144.04(V)(C) In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) “The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.") Claims 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al (US PG Pub 2006/0190042) in view of previously cited Vargas (US PG Pub 2015/0250470). Regarding claim 17, Stone teaches a tissue anchor delivery device (150) (See Figs. 18-24 and 29-33) comprising: a shaft (sleeve 170) having a distal opening (See Figs. 20-22; paragraph [0055]; a hollow needle (156) disposed within the shaft (170), the needle including a beveled7 tip (160), an inner lumen (See Figs. 29-30; paragraphs [0054] and [0060]), and a distal outlet (158); first (102) and second (102’) tissue anchors (See Figs. 17 and 22) disposed in the inner lumen of the needle (See Figs. 19, 22, 23, 29 and paragraphs [0050]-[0055]), each of the first and second tissue anchors comprising: a main body portion (120); a tab portion (128) that projects transversely from the main body portion and has a fully bounded suture aperture (130) having an axis that is perpendicular to a length dimension of the main body portion (See Figs. 2&3; paragraphs [0050]-[0051]; and a suture (106) portion that extends through the aperture perpendicular to the length dimension (See Fig. 6); and an advancement member (162) configured8 to push the first and second tissue anchors through the inner lumen of the needle and out of the distal outlet (See Figs. 19, 22, and 23; paragraphs [0054]-[0056]). Stone does not explicitly teach each of the first and second anchors has a tongue portion and a groove portion wherein the tongue portion of the first tissue anchor and the groove portion of the second tissue anchor are engaged within the inner lumen of the needle. Vargas teaches an analogous tissue anchor delivery device (See Figs. 2, 3, and 10) featuring a hollow needle (210/610/810) having a distal opening with at least two tissue anchors (300/220a/220b) disposed in the hollow needle where each anchor has a tongue (306) and groove (305) portion where the tongue portion (306) of the first tissue anchor (220a) and the groove portion (305) of the second tissue anchor (220b) are engaged within the inner lumen of the needle (See paragraph [0095]). Vargas teaches it is advantageous for the anchors to each have a male and female (tongue & groove) interlocking portion which hold the anchors together and prevent relative rotation between the anchors while constrained inside the hollow inner lumen of the delivery device. It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the tongue and groove interlocking end portions on the anchors as taught by Vargas into the delivery device as taught by Stone so as to ensure the anchors did not rotate relative to one another and ensured proper relative positioning while the anchors are inside the delivery device. Regarding claim 18, modified Stone teaches the tissue anchor delivery device as required by claim 17 above and further teaches each of the first and second tissue anchors comprises a recess (132) in a suture-holding surface opposite a flat tissue-contact surface (126) of the respective tissue anchor (See Stone Figs. 2 and 3 above); the tab portion (128) of each of the first and second tissue anchors projects from the suture-holding surface of the respective tissue anchor (See Figs. 2 & 3 above); and at least a portion of the suture portion (106) of the first tissue anchor is disposed in the recess of the first tissue anchor when the first and second tissue anchors are disposed in the inner lumen of the needle. (See paragraph [0050]). Regarding claim 19, modified Stone teaches the tissue anchor delivery device as required by claim 17 above and further teaches the needle (156) comprises a protruding member (166) disposed in the inner lumen within an area spanned by the distal outlet (See Figs. 19-23); the protruding member (166) is positioned to contact9 the tab portions of the of the first and second tissue anchors as the first and second tissue anchors are advanced through the inner lumen of the hollow needle; and the protruding member is configured10 to rotate each of the first and second tissue anchors when the first and second tissue anchors are pushed out of the distal outlet by the advancement member. (See paragraphs [0054]-[0055] and [0057]). Regarding claim 20, modified Stone teaches the tissue anchor delivery device as required by claim 17 above and further teaches the needle is retractable (See paragraphs [0054]-[0060]; note the outer sleeve 170 covers the tip 160 of the needle, thus the needle is “retractable” relative to the sleeve). Response to Arguments Applicant’s amendments have overcome the previous 112(b) rejections, however the amendments have created new 112(a) new matter issues as set forth above. 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. It is noted the Stone reference is now being applied to teach the claimed limitations. To the extent Vargas and Kiedar are applied, it is for specific features as part of an obviousness rationale as outlined above. Neither Vargas or Kiedar are relied upon for teaching the structures of the delivery device to which applicant’s arguments are directed. Citation of Relevant Prior Art The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Torrie et al (US PG Pub 2005/0283192) teaches a tissue anchor delivery device where the plurality of tissue anchors have a tab with a suture aperture therein (See Figs. 4A). Torrie also teaches the needle (100) has a beveled tip and angled opening (See Fig. 4C) and a protrusion (130a) which prevents pre-deployment of the anchor. 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 RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm . 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 call the examiner at the number listed above. Applicant may 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, 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. 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. /R.S.H/Examiner, Art Unit 3774 /SARAH W ALEMAN/Primary Examiner, Art Unit 3774 1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. The Cambridge Dictionary defines “beveled” as “having a sloping edge or surface”. As can clearly be seen in Figs. 30-33, the needle has a sloped tip portion (158 leading to tip 160). This is deemed sufficient to meet the claimed limitation. 2 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Stone teaches the anchor (102/102’) has a flat base (126) (See Fig. 2; paragraph [0050]). It is noted that the base 126 is capable of contacting tissue as there is nothing which would prevent the base from contacting tissue if so deployed. Additionally, it is noted that since the anchor is implanted within the body, almost all of the exterior surfaces will be in contact with at least some type of tissue. 3 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. It is noted that “retractable puncturing feature” is a very broad limitation and encompasses a broad range of structures so long as it can puncture and retract. 4 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Stone teaches a tab 166 projecting into the interior of the needle shaft 156 for the purpose of preventing accidental launching of the second anchor. It is noted that “configured to” is a recitation of intended use. As long as the prior art meets the structural requirements and is capable of performing the function, the prior art is deemed to meet the limitation. In the instant case, Stone teaches a protruding member (166) which has the same structure as claimed. 5 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the device as taught by Keidar teaches a suction catheter (See paragraph [0077]) which is capable of holding the device to a heart valve annulus or any other desired tissue deployment location. 6 It is noted that this is a product-by-process limitation, and as such only the product will be examined. As noted by the court in Thorpe. “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe. 777 F.2d 695, 698 (Fed. Cir. 1985) (citations omitted). The court further stated in Brown. “[w]e are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product by process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 173 USPQ 685, 688 (CCPA 1972). In the instant case, the tip 160 is attached to an end of the needle shaft 156. See 19, 22, 23, 29. 7 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. The Cambridge Dictionary defines “beveled” as “having a sloping edge or surface”. As can clearly be seen in Figs. 30-33, the needle has a sloped tip portion (158 leading to tip 160). This is deemed sufficient to meet the claimed limitation. 8 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Stone teaches slider 162 pushes and advances the anchor(s) (See paragraph [0054]) 9 Note that Stone as modified to incorporate the tongue and groove interlocking elements as set forth above would also result in the anchors being adjacent one another within the lumen of the needle and could thus have the tab portioned be aligned with the bottom of the needle where the protrusion 166 is located. 10 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Stone teaches a tab 166 projecting into the interior of the needle shaft 156 for the purpose of preventing accidental launching of the second anchor. It is noted that “configured to” is a recitation of intended use. As long as the prior art meets the structural requirements and is capable of performing the function, the prior art is deemed to meet the limitation. In the instant case, Stone teaches a protruding member (166) which has the same structure as claimed and would be capable of causing rotating the anchors as they are pushed passed the protruding member and out of the delivery device.
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Prosecution Timeline

Mar 28, 2022
Application Filed
Sep 29, 2025
Non-Final Rejection — §102, §103, §112
Nov 14, 2025
Response Filed
Feb 20, 2026
Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
67%
Grant Probability
99%
With Interview (+36.3%)
3y 11m
Median Time to Grant
Moderate
PTA Risk
Based on 348 resolved cases by this examiner. Grant probability derived from career allow rate.

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