Prosecution Insights
Last updated: April 18, 2026
Application No. 18/508,193

SUTURE DELIVERY DEVICE AND METHODS OF USE THEREOF

Final Rejection §103§DP
Filed
Nov 13, 2023
Examiner
DAVID, SHAUN L
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Xdot Medical Inc.
OA Round
2 (Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
3y 8m
To Grant
92%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
405 granted / 557 resolved
+2.7% vs TC avg
Strong +19% interview lift
Without
With
+19.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
58 currently pending
Career history
615
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
33.9%
-6.1% vs TC avg
§102
28.2%
-11.8% vs TC avg
§112
26.2%
-13.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 557 resolved cases

Office Action

§103 §DP
DETAILED ACTION This Office Action is a Response to Applicant’s Arguments and Amendment submitted 01/15/2026. 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 . Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: control elements/mechanism for controlling one or more components of the delivery device in claims 1/20, corresponding to actuation levers/buttons at [0055] of the spec. as filed; and resilient member configured to stop distal movement in claims 14/19, corresponding to a spring at [0088] of the spec. as filed. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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) 1-4, 6, 8-12, 16-17, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0105805 A1 to Fortson (hereinafter “Fortson”) (previously of record) in view of US 2013/0144316 A1 to McCrea et al. (hereinafter “McCrea”). Regarding claim 1, Fortson discloses (see abstract; Figs. 1-7B; and [0027]-[0050]) a delivery device (100) for suture deployment (see at least [0027]-[0031]), the delivery device comprising: a distal assembly (108 + 110) comprising an elongate member (110), a dilator (see Figs. 6A-B; tapered distal portion 108 acts as a dilator to dilate passageway 130); a proximal housing (107 + 109) comprising one or more control elements (122/123, which are actuation levers and thus correspond under 112f to the control elements as discussed above) for controlling one or more components of the delivery device (see Fig. 3A and [0036]); and a plurality of delivery tubes (112a/b) extending distally from the proximal housing into the elongate member, each of the plurality of delivery tubes comprising: a suture anchor (125a/b) stored within a distal portion of that delivery tube (see [0034]/[0037]), and a push rod (116a/b) configured to push the suture anchor distally out of the distal portion of that delivery tube for deployment of the suture anchor within a target tissue (see [0037], [0044]-[0046], and Figs. 3B and 6C-E). Fortson further discloses (claim 2) a guidewire lumen extending between a distal end and a proximal end of the delivery device (see Fig. 6A, accommodating guidewire 128, see also [0043]); (claim 3) a blood return channel (connecting distal end 108 to lumen 138, Fig. 1) extending between a distal port disposed within the distal assembly (i.e., distal end of 108 or 132/136) and a proximal port (138) disposed within the proximal housing, the blood return channel being configured to provide an indication of proper positioning of the distal assembly within the target tissue based on presence of blood in the proximal port (see Figs. 1/6B and [0043]); (claim 4) wherein the blood return channel is a passageway defined by an inner guidewire lumen and an outer tube (see Fig. 6B and [0043]); (claim 5) and a stabilizer in that it stabilizes the device within the lumen for deployment of suture anchors and sutures, see also [0043]); (claim 8) further comprising a removable sheath mounted over at least a distal portion of the elongate member (see [0033]); (claim 9) wherein the elongate member comprises: a proximal tubular portion (e.g., very top of Figs. 5A-5B); and a distal conical portion (formed by tapering of middle section in Fig. 5B) comprising a plurality of guiding features (angled surfaces shown in Fig. 5B) configured to position the plurality of delivery tubes in a desired configuration upon deployment (see Fig. 5B and [0041]); (claim 10) further comprising a passageway extending from a distal end of the elongate member into the proximal housing (interior of 110), the passageway being configured to receive a guidewire lumen, the plurality of delivery tubes, and an outer tube configured to define a blood return channel (see Figs. 3A-4 and [0043]); (claim 11) wherein each of the plurality of delivery tubes comprises an elongate tubular member extending distally, from a delivery tube holder in the proximal housing, into the passageway (see Fig. 3A and [0034]/[0036]/[0044]); (claim 12) that push rod extends distally into a lumen of that delivery tube from a push rod holder in the proximal housing (see Fig. 1 and [0034]/[0037]/[0045]); (claim 16) wherein each of the plurality of delivery tubes comprises a slot for receiving a distal end of a suture (118), the distal end of the suture being coupled with a suture anchor (see [0034]); and (claim 17) a positioning element (structure shown in Fig. 5B) disposed within a passageway including a guidewire lumen and configured to cause flaring of the plurality of delivery tubes outwardly with respect to the guidewire lumen upon deployment (see Fig. 5B and [0041]). Fortson fails to specifically disclose, with respect to claim 1, a stabilizer, wherein the stabilizer is disposed between the dilator and the elongate member, and with respect to claim 6, wherein the stabilizer has a diameter that is substantially similar to that of the dilator in an undeployed state. McCrea discloses (see abstract; Figs. 1-7C; and [0046]-[0069]) a delivery device (10) for suture deployment for post-procedure closure of an access site (see [0046]), the delivery device comprising a distal assembly (32 + 14 + 20, Fig. 2) comprising an elongate member (32), a stabilizer (14), and a dilator (20, tapered so functions as a dilator), wherein the stabilizer is disposed between the dilator and the elongate member (see Figs. 2 and 5A), wherein the stabilizer has a diameter that is substantially similar to that of the dilator in an undeployed state (see Figs. 2/6A and [0048]), in the same field of endeavor for the purpose of providing an anchor (correlating to the claimed “stabilizer”) which when expanded captures a portion of the vessel wall to stabilize the vessel wall relative to the device to allow for more optimal suturing (see [0056] & [0067]-[0069])). 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 Fortson’s device with the anchor/stabilizer taught by McCrea in order to provide an anchor which when expanded captures a portion of the vessel wall to stabilize the vessel wall relative to the device to allow for more optimal suturing. Regarding claim 18, Fortson as modified by McCrea above discloses (see abstract; Figs. 1-7B; and [0027]-[0050]) a method of deploying sutures using the delivery device of claim 1 (see rejection of claim 1 above and [0043]), the method comprising: advancing a distal end of the delivery device into the target tissue (see Figs. 6A-6B and [0043]); deploying, upon observation of blood return, a stabilizer (see discussion of McCrea above); distally advancing the plurality of delivery tubes into the target tissue (see Figs. 6C and [0044]); and distally advancing, upon detecting that the plurality of delivery tubes have reached a maximum advancement position, each push rod into a lumen of that delivery tube to cause deployment of that suture anchor (see Figs. 6D-6E and [0045]-[0047]). Regarding claim 21, the combination of Fortson and McCrea would further disclose wherein the outer tube comprises a distal port (136) of the blood return channel (see Fig. 6C and [0043]) of Fortson, wherein the distal port is positioned proximate to the stabilizer (when the anchor/stabilizer of McCrea is added to Fortson’s device as discussed above, the anchor 14 would be proximate the vessel wall within the vessel – the marker port 136 of Fortson likewise needs to be located proximate the vessel wall within the vessel (see [0043]) – accordingly, the anchor 14 would be proximate the distal port since both need to be located adjacent the vessel wall within the vessel. Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fortson in view of McCrea, as applied to claim 1 above, and further in view of US 2008/0269800 A1 to Spurchise et al. (hereinafter “Spurchise”) (previously of record). The combination of Fortson and McCrea discloses the invention substantially as claimed as discussed above, however, with respect to claim 7, the combination fails to specifically disclose wherein distal movement of an outer tube within the elongate member causes deployment of the stabilizer for providing temporary fixation of the delivery device at a location in the target tissue that will correctly position the suture anchors upon deployment. Spurchise discloses, in the same field of endeavor, an arteriotomy closure system (see abstract; Figs. 2C/6; and [0027]-[0030]), wherein distal movement of an outer tube (54) within an elongate member (14) causes deployment of a stabilizer (58) for providing temporary fixation of the delivery device at a location in the target tissue that will correctly position tissue fasteners upon deployment (see [0027]-[0030] and Figs. 2C/6) for the purpose of aligning the distal end of the elongate member with the arteriotomy and to stabilize it in that position for subsequent advancement of the tissue fastener by the arteriotomy is stretched laterally to tension the edges to draw them together in approximation (see [0027]). 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 combination's device with the mechanism for deploying the stabilizer as taught by Spurchise as it is a known mechanism for deploying a stabilizer and also in order to align the distal end of the elongate member with the arteriotomy and to stabilize it in that position for subsequent advancement of the tissue fastener by the arteriotomy is stretched laterally to tension the edges to draw them together in approximation. Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over over Fortson in view of McCrea, as applied to claim 1 above, and further in view of US 2013/0253579 A1 to Hundertmark et al. (hereinafter “Hundertmark”) (previously of record). Regarding claim 13, the combination of Fortson and McCrea discloses the invention substantially as claimed as discussed above, including wherein the proximal housing comprises a flip handle (122/123) such that rotational motion of the flip handle causes distal advancement of the delivery tube holder and the push rod holder (see Figs. 3A-B and [0036]-[0037]) but provides that any mechanism is useable with the device to transfer the motion of the flip handle to cause distal advancement (see [0036]-[0037]); however Fortson fails to specifically disclose a rack and pinion control mechanism. Hundertmark discloses, in the same field of endeavor of vascular puncture sealing devices (see abstract), the known use of a flip handle (62c, Fig. 5) such that rotational motion of the flip handle (see Fig. 5 and [0079]) causes distal translation of a shaft (20) using a rack (64c/66c) and pinion (68c) control mechanism (see Fig. 5 and [0079]). Thus, Hundertmark discloses the particular construction of how a rotational flip handle can cause distal movement of a shaft connected to the handle via a known rack and pinion mechanism, and Fortson does not specify any particular mechanism for connecting the flip handles 122/123 to their respective delivery tube or push rod holders. Therefore, 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 combination's device with the rack and pinion mechanism taught by Hundertmark, as a matter of combining prior art elements according to known methods to yield predictable results (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a suitable known mechanism for tying a flip handle to cause distal translation). Regarding claim 14, the combination of Fortson/McCrea and Hundertmark discloses the invention substantially as claimed as discussed above. Hundertmark further discloses a resilient member (spring 78a, which corresponds under 112f to the resilient member as set forth above) configured to stop distal movement of the delivery tube holder when in a fully compressed state (see [0082]) for the purpose of providing a stop which then will facilitate and/or automatically retract the shaft during a procedure (see [0082]). Thus, it would have further been obvious to modify Fortson/McCrea/Hundertmark as discussed above with the spring of Hundertmark in order to provide a stop which then will facilitate and/or automatically retract the shaft during a procedure. Regarding claim 15, the combination of Fortson/McCrea and Hundertmark discloses the invention substantially as claimed as discussed above, and further, Fortson would disclose wherein distal movement of the push rod holder upon stopping of distal movement of the delivery tube holder causes, via the push rod, deployment of the suture anchor within the target tissue (see Figs. 3A-3B; 6C-6D; and [0043]-[0047]). Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fortson in view of Hundertmark. Regarding claim 19, Fortson discloses (see abstract; Figs. 1-7B; and [0027]-[0050]) a delivery device (100) for suture deployment (see at least [0027]-[0031]), the delivery device comprising: an outer tube (108/110) disposed concentrically around a guidewire lumen (see [0043]) to form a blood return channel (136/138) outside the guidewire lumen (see Fig. 1 and [0043]); a passageway (within 102) defined by the delivery device (see Fig. 1), the passageway configured to house the outer tube and a plurality of delivery tubes (112a/b); the plurality of delivery tubes extending distally from a delivery tube holder (see Fig. 3A and [0034]/[0036]/[0044]), each of the plurality of delivery tubes comprising: a suture anchor (125a/b) stored within a distal portion of that delivery tube (see [0034]/[0037]), and a push rod (116a/b) extending from a push rod holder and configured to push the suture anchor distally out of the distal portion of that delivery tube for deployment of the suture anchor within a target tissue (see [0037], [0044]-[0046], and Figs. 3B and 6C-E), wherein distal movement of the push rod holder causes, via the push rod, deployment of the suture anchor within the target tissue (see [0037], [0044]-[0046], and Figs. 3B and 6C-E). Fortson further discloses (claim 20) a control mechanism (122/123, which are actuation levers and thus correspond under 112f to the control elements as discussed above) configured to cause distal advancement of the delivery tube holder and the push rod holder (see Fig. 1 and [0044]-[0045] & [0055]). Fortson fails to specifically disclose, with respect to claim 19, a resilient member configured to stop distal movement of the delivery tube holder when in a fully compressed state, wherein deployment of the suture anchor within the target tissue based on distal movement of the push rod holder is based upon stopping of distal movement of the delivery tube holder. Hundertmark discloses, in the same field of endeavor of vascular puncture sealing devices (see abstract), the known use of a flip handle (62c, Fig. 5) such that rotational motion of the flip handle (see Fig. 5 and [0079]) causes distal translation of a shaft (20) using a rack (64c/66c) and pinion (68c) control mechanism (see Fig. 5 and [0079]), and further discloses a resilient member (spring 78a, which corresponds under 112f to the resilient member as set forth above) configured to stop distal movement of the delivery tube holder when in a fully compressed state (see [0082]) for the purpose of providing a stop which then will facilitate and/or automatically retract the shaft during a procedure (see [0082]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fortson with the spring of Hundertmark in order to provide a stop which then will facilitate and/or automatically retract the shaft during a procedure. In making the proposed combination, the result would be that distal movement of the push rod holder (Fig. 3B) upon stopping of distal movement of the delivery tube holder (Fig. 3A) would causes, via the push rod, deployment of suture anchor within the target tissue (see [0037], [0044]-[0046], and Figs. 3B and 6C-E). Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-21 of copending Application No. 18/662,909 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are broader than, and thus are “anticipated” by, the claims of the ’909 copending application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Arguments Applicant’s arguments with respect to claim(s) 1-18 and 21 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. Applicant's arguments filed 01/15/2026 with respect to claims 19-20 and the double patenting rejection have been fully considered but they are not persuasive. With respect to the double patenting rejection, the mere fact that a terminal disclaimer was filed in the copending application to disclaim over the current application does not overcome a double patenting rejection in the current application over the copending application – see MPEP 804. Accordingly, the provisional double patenting rejection is maintained. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “to form a blood return channel outside the guidewire lumen” means “the blood return channel 104 may be a passageway that is concentrically provided around at least a portion of the guidewire lumen such that blood flows in a space outside the guidewire lumen wall and inside an outer tube 105 disposed concentrically around the guidewire lumen” as per [0057] of the spec. as filed) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim merely requires an outer tube disposed concentrically around a guidewire lumen (Fortson’s outer tube 108 is shown in Fig. 6A disposed concentrically around a lumen accommodating guidewire 128), and the blood return channel is formed outside the guidewire lumen (here, BRI of outside includes where “outside” means “separate”, “away from”, or “external to” the guidewire lumen). The blood return channel is formed external to, away from, and separate from the guidewire lumen as the guidewire lumen and blood return channel are not the same passageway nor are they of the same length. Accordingly, Applicant’s arguments are not persuasive. 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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM. 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 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, Darwin Erezo can be reached at 571-272-4695. 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. /SHAUN L DAVID/Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Nov 13, 2023
Application Filed
Feb 09, 2024
Response after Non-Final Action
Sep 19, 2025
Non-Final Rejection — §103, §DP
Jan 15, 2026
Response Filed
Apr 08, 2026
Final Rejection — §103, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
73%
Grant Probability
92%
With Interview (+19.4%)
3y 8m
Median Time to Grant
Moderate
PTA Risk
Based on 557 resolved cases by this examiner. Grant probability derived from career allow rate.

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