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 for controlling one or more components of the delivery device in claim 1, corresponding to actuation levers/buttons at [0055] of the spec. as filed; and resilient member configured to stop distal movement in claim 16, 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 Objections
The objection to claim(s) 1 and 19 in the previous Office Action for informalities is hereby withdrawn in view of Applicant’s Amendment.
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) 1-8, 10-14, and 18-21 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 for post-procedure closure of an access site (see at least [0027]-[0031] and [0006]), the delivery device comprising: a distal assembly (108 + 110) comprising an elongate member (110) and 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) 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) around the access site after removal of an interventional device from the access site (see [0001]-[0013]).
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) wherein a length of the dilator is configured to plug the access site to prevent leakage of blood from the access site such that presence of blood in the proximal port provides the indication of proper positioning of the distal assembly within the target tissue (see Figs. 6A-6B and [0043]); (claim 8) wherein the stabilizer is disposed between the dilator and the elongate member and has a diameter that is substantially similar to that of the dilator in an undeployed state (see Figs. 6A-B); (claim 10) further comprising a removable sheath mounted over at least a distal portion of the elongate member (see [0033]); (claim 11) 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 12) 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 13) 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 14) 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 18) 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 19a) 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 wherein the dilator has a diameter of about 10-20 French, a stabilizer, wherein the stabilizer is disposed between the dilator and the elongate member. Fortson further fails to specifically disclose, with respect to claim 6, wherein the length of the dilator is about 1 – 5 inches, with respect to claim 7 the stabilizer having a total wing span of about 2 mm to about 6 mm in an expanded state, and with respect to claim 21, although Fortson discloses wherein each of the plurality of delivery tubes comprises a distal portion that flares outwardly with respect to the proximal portion of that delivery tube such that the sutures are deployed (see Figs. 3A/3B/5B/6C/6D), Fortson fails to disclose wherein sutures are deployed to form an area having a rectangular cross section of about 3 mm X 8 mm.
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 6A) 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.
Fortson's dilator has an unspecified diameter and length, McCrea's stabilizer has an unspecified wing span, and Forston's device applies the sutures to an unspecified dimension of the arteriotomy. Applicant's specification states that the claimed dilator diameter allows for plugging of the access site with the dilator in order to prevent blood loss through the access site upon removal of the interventional device (spec. as filed at [0102]) - Fortson's dilator 108 likewise plugs the access site with the dilator in order to prevent blood loss through the access site upon removal of the interventional device (see Fig. 6A-->6B, showing the access site completely blocked by the dilator as it is inserted). Applicant's specification states that the claimed dilator length allows for stopping leakage of blood completely from the access site upon insertion of a suitable length of the dilator within the access site before the distal blood return port is positioned within the vessel (spec. as filed at [0103]) - Fortson's dilator 108 likewise has a suitable length which, as one goes from Fig. 6A --> Fig. 6B, blood leakage will be prevented as the dilator is inserted before the distal blood return port (136) is positioned within the vessel. Applicant's specification states that the claimed stabilizer wing span to ensure accurate referencing of the anterior vessel wall with respect to the access site so as to provide adequate anchorage (spec. as filed at [0104]) - McCrea's stabilizer portion 14 likewise has a size which ensures accurate referencing of the anterior vessel wall with respect to the access site so as to provide adequate anchorage (see Fig. 7A/C). Applicant's specification states that the rectangular cross section size to which the sutures are deployed are determined based on the size of the access site to be closed (spec. as filed at [0105]). Accordingly, Fortson's device comprises the same structures which perform the same functions, but does not specify the specific diameters. However, 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 (as modified by McCrea above) to have the claimed dimensions, since Fortson's modified device comprises the same structures which perform the same functions, 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 relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Regarding claim 20, Fortson as modifed by McCrea 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 into a previously enlarged access site until the access site is plugged to prevent leakage of blood from the access site (see Figs. 6A-6B and [0043]; see also [0001]-[0013]); 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]).
Claim(s) 9 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 9, 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) 15-17 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 2013/0253579 A1 to Hundertmark et al. (hereinafter “Hundertmark”) (previously of record).
Regarding claim 15, 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 16, the combination of Fortson/McCrea and Hundertmark discloses the invention substantially as claimed as discussed above. Hundertmark further discloses a resilient member (spring 78a) 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 17, the combination of Fortson/McCrea and Hundertmark discloses the invention substantially as claimed as discussed above, and further, Forston 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]).
Terminal Disclaimer
The terminal disclaimer filed on 01/15/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of application 18/508,193 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-21 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.
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.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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