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 .
Examiner’s Note
The Examiner contacted Applicant’s representative for the purpose of proposing an Examiner’s amendment to the independent claims in order to put the Application in condition for allowance; the Examiner suggested defining the film being attached to the anastomosis device via an adhesive (as disclosed in the Instant Disclosure) and including the second constraining mechanism releasably securing the intermediate portion in a intermediate state with an intermediate diameter greater than the delivery diameter, and the second constraining mechanism releasing the intermediate portion to the fully deployed diameter that is greater than the intermediate diameter. However, no agreement could be reached, and Applicant’s representative opted for the rejection to be sent out.
Response to Amendment
This Office action is in response to the applicant’s communication filed 10/27/2025.
Status of the claims:
Claims 1 – 4 and 6 – 11 are pending in the application.
Claims 1 and 11 are amended.
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:
the generic placeholders are “a constraining mechanism”, “a first constraining mechanism” in claims 1 and/or 11, which are coupled to the functional language “configured to constrain at least a portion of the expandable anastomosis device”, and “a second constraining mechanism” in claim 8, which is coupled to the functional language “constrains the intermediate portion [of the expandable anastomosis device] in an intermediate configuration. Furthermore, there are no structural modifiers following the generic placeholders. For the purpose of examination, the first and second constraining mechanisms will be read in light of Applicant’s disclosure as being a tubular member that constrains the anastomosis device longitudinally and/or equivalents thereof (first constraining mechanism is shown in Figs. 2 – 4 as an outer sheath / capsule) and a thread / wire / suture and/or equivalents thereof (second constraining mechanism is shown in Figs 5 – 6B as a wire / thread / suture), respectively.
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.
Terminal Disclaimer
The terminal disclaimer filed on 02/10/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,724,075 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 1 – 4 and 6 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen et al (US 2010/0114290 A1) (previously cited), and in view of Fleury (US 2015/0265437 A1) (cited in IDS), Irwin et al (US 2015/0250630 A1) (cited in IDS), Stenzel et al (US 6,830,575 B2) (previously cited), and Merk et al (US 2018/0008444 A1).
Regarding claims 1 and 10, Rasmussen discloses a delivery system for an expandable medical device (stent graft introducer assembly for a stent graft 18) (abstract, paragraphs [0058], [0061], and Figs. 6 – 8) (Examiner’s note: it should be understood that the Examiner is relying upon the stent graft 18 with the delivery catheter system of Fig. 6, which is the same as the delivery system of Figs. 1 and 2 except with the addition of the trigger wires 42’ as stated in paragraph [0057]), comprising:
a catheter body (inner catheter 24) (paragraph [0057] and Figs. 6 – 7);
an expandable anastomosis device1 (stent graft 18) arranged on the catheter body (paragraph [0057] and Fig. 7), the expandable anastomosis device (stent graft 18) including a first end portion (see annotated Fig. 7), a second end portion (see annotated Fig. 7), and an intermediate portion (stent 4’ and designated in annotated Fig. 7) therebetween, the first end portion transitioning to the intermediate portion at a first inflection area and the second end portion transitioning to the intermediate portion at a second inflection area (see annotated Fig. 7) when the anastomosis device is released from a constraining mechanism and is in a fully deployed configuration (Examiner’s note: as shown in Fig. 7 the proximal and distal portions of the stent graft 18 are in the fully deployed configuration as the portions are fully expanded within the vessel; additionally, as shown in Fig. 8 and discussed in paragraph [0061], when the entire stent graft 18 is fully expanded (i.e., fully deployed) the first and second inflection areas are still present as the stent portion 4’ does not expand to the same diameter of the proximal and distal portions);
a first constraining mechanism (sheath 32) (Examiner’s note: as stated above, the first constraining mechanism is being interpreted under 112(f) as a tubular member that constrains the of a stent graft or equivalent thereof as defined by Applicant’s disclosure in Figs 2 – 4; and sheath 32 is a tubular member that constrains the stent graft (paragraph [0057]) and is thus considered to be equivalent to Applicant’s first constraining mechanism) configured to constrain at least a portion of the expandable anastomosis device in a delivery configuration (configuration when the stent graft 18 is fully compressed against the inner catheter 24) (Examiner’s note: as stated in paragraph [0057] the sheath 32 compresses / constrains the stent graft into the delivery configuration);
a second constraining mechanism (release wires 42; designated in annotated Fig. 7) (Examiner’s note: as stated above, the second constraining mechanism is being interpreted under 112(f) as a mechanism that constrains the medical device circumferentially and linked to the structure disclosed in Applicant’s Figs. 5 – 6 which is interpreted as a wire, suture, thread, or equivalent thereof; and release wires 42 are equivalent in structure and thus encompass a second constraining mechanism as defined by Applicant),
wherein the second constraining mechanism (release wires 42) is positioned about the intermediate portion (stent 4’ and designated in annotated Fig. 7 – Rasmussen) of the expandable anastomosis device (Examiner’s note: as shown in the annotated Fig. 7, Fig. 7, and discussed in paragraph [0058] of Rasmussen the release wires 42 (i.e., the second constraining mechanisms) are positioned about the intermediate portion).
However, Rasmussen is silent regarding [claims 1 and 10] (i) wherein intermediate portion of the expandable anastomosis device exerts a radially expansive force that is greater than a radially expansive force of the first and second end portions of the expandable anastomosis device, [claim 1] (ii) a deployment line coupled to the first constraining mechanism, the deployment line being operable to release the first constraining mechanism in response to tension applied to the deployment line, (iii) a skirt couple to a distal side of the first constraining mechanism so as to cover a part of the first constraining mechanism, and (iv) wherein the second constraining mechanism is a film. With respect to (ii) and to further the Examiner’s position below, Rasmussen further discloses, in paragraph [0058], wherein the sheath 32 (first constraining mechanism) is pulled back / withdrawn to expose the stent graft 18; thus, Rasmussen discloses withdrawing / releasing the first constraining mechanism in response to some form of tension.
As to (i), Fleury teaches, in the same field of endeavor, a stent (stent 10) used for a plurality of operations such as the coronary vessels (paragraphs [0003 – 0006]) (which are similar uses of the stent graft 18 listed in the disclosure of Rasmussen paragraph [0009]); wherein the stent (stent 10; which is equated to the stent graft 18 of Rasmussen) has an intermediate portion (center region; which equates to the intermediate portion of the stent graft 18 of Rasmussen) and two end portions (end regions; which equate to the first and second end portions of the stent graft 18 of Rasmussen), wherein the intermediate portion (center region) exerts a radially expansive force that is greater than a radially expansive force of the first and second end portions (Examiner’s note: as stated in paragraphs [0043 – 0045], the radial force / outward radial force applied by the stent against the vessel wall is greater in the center region than the radial force of the ends of the stents), for the purpose of minimizing or eliminating swelling and granulation of tissue when the stent is implanted in the body lumen (paragraph [0043]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the stent of Rasmussen to have the center region / intermediate portion of the stent exert a greater radial force compared to the end portions, as taught by Fleury, for the purpose of minimizing or eliminating swelling and granulation of tissue when the stent is implanted in the body lumen (paragraph [0043] – Fleury).
It should be understood that the modification made above is such that the stent graft 18, of Rasmussen, is modified to include the strut arrangement of the stent of Fleury, such that the intermediate portion exerts the radially expansive force on the vessel wall that is greater than the radially expansive force of the first and second end portions.
As to (ii), Irwin teaches, in the same field of endeavor, a stent delivery system comprising an expandable medical device (implantable device 20) and a first constraining member (sheath element 26; which equates to the sheath 32 of Rasmussen) (paragraphs [0031 – 0032], [0034], and [0050 – 0051] and Fig. 8); Irwin further teaches a deployment line (deployment line 34) (paragraphs [0034] and [0050 – 0051] and Fig. 8), operatively coupled to the first constraining member (sheath element 26) (paragraph [0034]) for the purpose of being able to effectively retract the constraining mechanism and ultimately control the deployment of the expandable medical device.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Rasmussen to include the deployment line of Irwin for the purpose of being able to effectively retract the constraining mechanism and being able to control the deployment of the expandable medical device at the desired location.
As to (iii), Stenzel teaches, in the same field of endeavor, a delivery system (catheter 10) for an expandable medical device (stent 24; which equate to the stent graft 18 of Rasmussen) (abstract, column 8 lines 1 – 15, and Figs, 16 – 17) comprising a catheter body (catheter 10), an expandable medical device (stent 24), a first constraining mechanism (retractable sleeve 60; which equates to sheath 32 of Rasmussen) configured to restrain the expandable medical device in a delivery configuration (shown in Fig. 16), and a skirt (winged sleeve 50) arranged about the first constraining mechanism (Examiner’s note: as shown in Fig. 16 and discussed in column 8 lines 1 – 15 the winged sleeve 50 overlaps the distal end of the retractable sleeve), for the purpose of preventing unintended or premature retraction of the sleeve 60 (column 8 line 1 – 15).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the delivery system of Rasmussen in view of Irwin to incorporate the winged sleeve 50, as taught by Stenzel, for the purpose of preventing unintended or premature retraction of the sleeve 60 (column 8 line 1 – 15 – Stenzel).
It should be understood that prior art makes it obvious or suggests that the modification would encompass the winged sleeve 50, of Stenzel, being attached to the proximal end of the dilator tip 20, of Rasmussen, and stretching proximally over the distal end of the sheath 32 of Rasmussen, as this is the same position and orientation of the winged sleeve 50 over the distal end of the retractable sleeve of Stenzel (which equates to the sheath 32 of Rasmussen). Furthermore, because modified device encompasses the winged sleeve over the distal end of the sheath 32 (i.e., the first constraining mechanism) of Rasmussen, the modified device would also encompass the winged sleeve being coupled to the distal side. Therefore, the combination encompasses the limitations above.
As to (iv), Merk teaches a multi-stage balloon catheter comprising a constraining mechanism (breakable film hoops 84; which equate to the release wires 42 of Rasmussen as they are releasable constraints intended to release a portion of an implantable device when desired), wherein the constraining mechanism (breakable film hoops 84) includes a film (abstract, paragraphs [0024], [0040 – 0041], and Fig. 21).
It should be understood that Rasmussen and Merk are known references in the art that teach an implant delivery system comprising multi-stage expansion via constraining mechanisms (abstract, paragraphs [0058], [0061], and Figs. 6 – 8 – Rasmussen ; abstract, paragraphs [0024], [0040 – 0041], and Fig. 21 – Merk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one type of constraining mechanism for another (i.e., modifying the releasable sutures of Rasmussen to be breakable film loops), and the results of the substitution would have been predictable and resulted in the modified constraining mechanism of Rasmussen being able to function as intended to properly constrain and release the stent segment of the stent of Rasmussen. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Annotated Figure 7 of Rasmussen
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Regarding claim 2, as discussed above, it would be obvious to modify the delivery system of Rasmussen in view of Fleury, Merk, and Irwin with the skirt of Stenzel. The combination further teaches the skirt (winged sleeve 50 – Stenzel) is operable to be positioned about the first constraining mechanism (sheath 32 – Rasmussen) when the delivery system is being advanced toward a target location within a patient (Examiner’s note: as stated in the rejection of claim 1 above, the modified device is configured such that the winged sleeve 50, of Stenzel, is arranged about the distal end of the sheath 32 during delivery of the medical device). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 3, as discussed above, it would be obvious to modify the delivery system of Rasmussen in view of Fleury, Merk, Irwin, and Stenzel. Additionally, Rasmussen further teaches comprising a distal tip (dilator tip 20 – Rasmussen) positioned at a distal end of the catheter body (inner catheter 24 – Rasmussen) (paragraph [0040] and Fig. 7 – Rasmussen).
Regarding claim 4, as discussed above, the delivery system of Rasmussen in view of Fleury, Merk, Irwin, and Stenzel teaches the device of claim 3.
However, the combination as currently set forth above is silent regarding wherein the first constraining mechanism is operable to evert from the distal tip toward a proximal end of the catheter body.
As to the above, Irwin further teaches, in the same field of endeavor, wherein the first constraining mechanism (sheath element 26; which equates to the sheath 32 of Rasmussen) is operable to evert in response to the deployment line (deployment line 34) (Examiner’s note: as discussed in paragraphs [0034], [0042], [0048], [0050 – 0051] and shown in Figs. 7 and 8, pulling the deployment line 34 everts the sheath element 26 in order to deploy the implantable device 20 into the body) for the purpose of reducing the amount of proximally directed frictional pull on the implantable medical device during deployment by the sheath element, thereby mitigating the amount unintended axial movement of the expandable deployment device away from the intended deployment location.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to further modify the delivery system of Rasmussen in view of Fleury, Irwin, and Stenzel to incorporate the everting first constraining mechanism of Irwin for the purpose of reducing the amount of proximally directed frictional pull on the implantable medical device during deployment by the sheath element, thereby mitigating the amount unintended axial movement of the expandable deployment device away from the intended deployment location.
It should be understood that the modification made here is such that the sheath 32, of Rasmussen, is replaced with the sheath element 26, of Irwin. Furthermore, the modified device encompasses the winged sleeve 50 of Stenzel now covering the distal end of the sheath element 26.
Annotated Figure 7 of Rasmussen
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Regarding claim 6, as discussed above, it would be obvious to modify the delivery system of Rasmussen in view of Fleury, Merk, Irwin, and Stenzel. The combination further teaches wherein the first constraining mechanism (sheath element 26 – Irwin) is positioned about the first end portion, the second end portion, and the intermediate portion of the expandable anastomosis device (Examiner’s note: as discussed in the rejection of claim 4, the device of Rasmussen is modified to replace the sheath 18 with the sheath element 26 of Irwin. Additionally, as shown in Fig. 2 and discussed in paragraph [0057] of Rasmussen, the sheath 32 covers stent graft 18; therefore the sheath element 26 of Irwin would also cover the entire length of the stent graft 18). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 7, as discussed above, it would be obvious to modify the delivery system of Rasmussen in view of Fleury, Mer, Irwin, and Stenzel. The combination further teaches wherein the first constraining mechanism (sheath element 26 – Irwin) is operable to release and deploy the first end portion and the second end portion of the expandable anastomosis device (stent graft 18 – Rasmussen) to a fully-deployed configuration (configuration shown in Fig. 7 – Rasmussen) in response to release thereof (Examiner’s note: as discussed in paragraph [0058] once the sheath (in this case sheath element 26 of Irwin – see modification made in the rejection of claim 4) is withdrawn the stent is allowed to expand; and as there are no other constraining mechanisms constraining the first end and second end portions then said portions will expand to their fully deployed configuration shown in Fig. 7 of Rasmussen). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 8, as discussed above, it would be obvious to modify the delivery system of Rasmussen in view of Fleury, Merk, Irwin, and Stenzel. Additionally, Rasmussen further teaches wherein the second constraining mechanism (release wires 42 – Rasmussen) constrains the intermediate portion (stent 4’ and designated in annotated Fig. 7 – Rasmussen) in an intermediate configuration (partial expansion configuration – Rasmussen) after release of the first constraining mechanism (sheath element 26 – Irwin) and the first and second end portions of the expandable anastomosis device (stent graft 18 – Rasmussen) is in the fully-deployed configuration (Examiner’s note: as stated in paragraph [0058] the intermediate portion, stent 4’, remains in a constrained state after the withdraw of the sheath 32 (in this case the sheath element 26 of Irwin) via the release wires 42; and as stated in paragraph [0058] the constrained stent 4’ expands partially prior to the release of the constraining mechanism (i.e. the release wires 42) in the constrained state; therefore the intermediate portion, stent 4’, will expand to an intermediate configuration after the withdraw of the sheath and the full deployment of the first and second end portions of the stent graft 18 – Rasmussen). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 9, as discussed above, it would be obvious to modify the delivery system of Rasmussen in view of Fleury, Merk, Irwin, and Stenzel. The combination teaches wherein the second constraining mechanism (release wires 42 – Rasmussen) is arranged between the first constraining mechanism (sheath element 26 – Irwin) and the expandable anastomosis device when in the delivery configuration (Examiner’s note: as stated above, the modification is such that the sheath element 26 of Irwin, covers the stent graft 18 of Rasmussen which is also constrained by the release wires 42 of Rasmussen, therefore the second constraining mechanism would be arranged between the sheath element 26 of Irwin and the stent graft 18 of Rasmussen). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen et al (US 2010/0114290 A1) (previously cited), and in view of Irwin et al (US 2015/0250630 A1) (cited in IDS), Stenzel et al (US 6,830,575 B2) (previously cited), and Merk et al (US 2018/0008444 A1).
Regarding claim 11, Rasmussen discloses a delivery system for an expandable medical device (stent graft introducer assembly for a stent graft 18) (abstract, paragraph [0061], and Figs. 6 – 8) (Examiner’s note: it should be understood that the Examiner is relying upon the stent graft 18 with the delivery catheter system of Fig. 6, which is the same as the delivery system of Figs. 1 and 2 except with the addition of the trigger wires 42’ as stated in paragraph [0057]), comprising:
a catheter body (inner catheter 24) (paragraph [0057] and Figs. 6 – 7);
an expandable anastomosis device2 (stent graft 18) arranged on the catheter body (paragraph [0057] and Fig. 7), the expandable anastomosis device (stent graft 18) including a first end portion (see annotated Fig. 7), a second end portion (see annotated Fig. 7), and an intermediate portion (stent 4’ and designated in annotated Fig. 7) therebetween, the first end portion transitioning to the intermediate portion at a first inflection area and the second end portion transitioning to the intermediate portion at a second inflection area (see annotated Fig. 7) when the anastomosis device is in the deployed configuration (Examiner’s note: as shown in Fig. 7 the stent graft 18 is in a deployed configuration as it is deployed within the vessel);
a first constraining mechanism (sheath 32) (Examiner’s note: as stated above, the first constraining mechanism is being interpreted under 112(f) as a tubular member that constrains the of a stent graft or equivalent thereof as defined by Applicant’s disclosure in Figs 2 – 4; and sheath 32 is a tubular member that constrains the stent graft (paragraph [0057]) and is thus considered to be equivalent to Applicant’s first constraining mechanism) configured to constrain at least a portion of the expandable anastomosis device in a delivery configuration (configuration when the stent graft 18 is fully compressed against the inner catheter 24) (paragraph [0057]) and configured to deploy the first end portion and the second end portion to a deployed configuration in response to release of the first constraining mechanism such that the expandable anastomosis device is released from the first constraining mechanism (paragraph [0061] and Figs. 7 – 8) (Examiner’s note: as shown in Fig. 7 the stent graft 18 (i.e., the expandable anastomosis device) is released from the sheath 32 (i.e., the first constraining mechanism));
a second constraining mechanism (release wires 42; designated in annotated Fig. 7) (Examiner’s note: as stated above, the second constraining mechanism is being interpreted under 112(f) as a mechanism that constrains the medical device circumferentially and linked to the structure disclosed in Applicant’s Figs. 5 – 6 which is interpreted as a wire, suture, thread, or equivalent thereof; and release wires 42 are equivalent in structure and thus encompass a second constraining mechanism as defined by Applicant),
wherein the second constraining mechanism (release wires 42) is positioned about the intermediate portion (stent 4’ and designated in annotated Fig. 7 – Rasmussen) of the expandable anastomosis device (Examiner’s note: as shown in the annotated Fig. 7, Fig. 7, and discussed in paragraph [0058] of Rasmussen the release wires 42 (i.e., the second constraining mechanisms) are positioned about the intermediate portion).
However, Rasmussen is silent regarding (i) a deployment line coupled to the first constraining mechanism, the deployment line being operable to release the first constraining mechanism in response to tension applied to the deployment line, (ii) a skirt arranged about the first constraining mechanism, and (iii) wherein the first constraining mechanism extends from a proximal end of the expandable ananastasias device to a distal end of the expandable anastomosis device and back toward the proximal end of the expandable anastomosis device, and (iv) wherein the second constraining mechanism is a film. With respect to (i) and to further the Examiner’s position below, Rasmussen further discloses, in paragraph [0058], wherein the sheath 32 (first constraining mechanism) is pulled back / withdrawn to expose the stent graft 18; thus, Rasmussen discloses withdrawing / releasing the first constraining mechanism in response to some form of tension.
As to (i) and (iii), Irwin teaches, in the same field of endeavor, a stent delivery system comprising an expandable medical device (implantable device 20) and a first constraining member (sheath element 26; which equates to the sheath 32 of Rasmussen) (paragraphs [0031 – 0032], [0034], and [0050 – 0051] and Fig. 8) and a deployment line (deployment line 34) (paragraphs [0034] and [0050 – 0051] and Fig. 8), operatively coupled to the first constraining member (sheath element 26) (paragraph [0034]) for the purpose of being able to effectively retract the constraining mechanism and ultimately control the deployment of the expandable medical device. Additionally, Irwin teaches wherein the first constraining mechanism (sheath element 26; which equates to the sheath 32 of Rasmussen) extends from a proximal end of the medical device to a distal end of the medical device and back toward a proximal end of the medical device (paragraphs [0034], [0042], [0048], [0050 – 0051] and shown in Figs. 1 and 7) for the purpose of allowing the sheath to evert which aids in reducing the amount of proximally directed frictional pull on the implantable medical device during deployment by the sheath element, thereby mitigating the amount unintended axial movement of the expandable deployment device away from the intended deployment location.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Rasmussen to include the deployment line of Irwin for the purpose of being able to effectively retract the constraining mechanism and being able to control the deployment of the expandable medical device at the desired location. Furthermore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Rasmussen to incorporate the first constraining mechanism of Irwin for the purpose of having a sheath that is capable of everting which aids in reducing the amount of proximally directed frictional pull on the implantable medical device during deployment by the sheath element, thereby mitigating the amount unintended axial movement of the expandable deployment device away from the intended deployment location.
As to (ii), Stenzel teaches, in the same field of endeavor, a delivery system (catheter 10) for an expandable medical device (stent 24; which equate to the stent graft 18 of Rasmussen) (abstract, column 8 lines 1 – 15, and Figs, 16 – 17) comprising a catheter body (catheter 10), an expandable medical device (stent 24), a first constraining mechanism (retractable sleeve 60; which equates to sheath 32 of Rasmussen) configured to restrain the expandable medical device in a delivery configuration (shown in Fig. 16), and a skirt (winged sleeve 50) arranged about the first constraining mechanism (Examiner’s note: as shown in Fig. 16 and discussed in column 8 lines 1 – 15 the winged sleeve 50 overlaps the distal end of the retractable sleeve), for the purpose of preventing unintended or premature retraction of the sleeve 60 (column 8 line 1 – 15).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the delivery system of Rasmussen in view of Irwin to incorporate the winged sleeve 50, as taught by Stenzel, for the purpose of preventing unintended or premature retraction of the sleeve 60 (column 8 line 1 – 15 – Stenzel).
It should be understood that prior art makes it obvious or suggests that the modification would encompass the winged sleeve 50, of Stenzel, being attached to the proximal end of the dilator tip 20, of Rasmussen, and stretching proximally over and coupled to the distal side of the sheath element 26 of Irwin, as this is the same position and orientation of the winged sleeve 50 over the distal end of the retractable sleeve of Stenzel (which equates to the sheath element 26 of Irwin). Therefore, the combination encompasses the skirt (sleeve 50 – Stenzel) arranged about the first constraining mechanism (sheath element 26 – Irwin).
As to (iv), Merk teaches a multi-stage balloon catheter comprising a constraining mechanism (breakable film hoops 84; which equate to the release wires 42 of Rasmussen as they are releasable constraints intended to release a portion of an implantable device when desired), wherein the constraining mechanism (breakable film hoops 84) includes a film (abstract, paragraphs [0024], [0040 – 0041], and Fig. 21).
It should be understood that Rasmussen and Merk are known references in the art that teach an implant delivery system comprising multi-stage expansion via constraining mechanisms (abstract, paragraphs [0058], [0061], and Figs. 6 – 8 – Rasmussen ; abstract, paragraphs [0024], [0040 – 0041], and Fig. 21 – Merk); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one type of constraining mechanism for another (i.e., modifying the releasable sutures of Rasmussen to be breakable film loops), and the results of the substitution would have been predictable and resulted in the modified constraining mechanism of Rasmussen being able to function as intended to properly constrain and release the stent segment of the stent of Rasmussen. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Annotated Figure 7 of Rasmussen
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Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive. Applicant’s arguments are directed to newly added limitations which have been addressed in the rejection above.
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.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
1 The limitation only requires the prior art to be capable of being used as an anastomosis device; and because the stent graft 18 of Rasmussen is an elongated hollow tubular member, then the stent graft 18 is capable of being used as an anastomosis device. Therefore, the limitation is encompassed in view of Rasmussen.
2 The limitation only requires the prior art to be capable of being used as an anastomosis device; and because the stent graft 18 of Rasmussen is an elongated hollow tubular member, then the stent graft 18 is capable of being used as an anastomosis device. Therefore, the limitation is encompassed in view of Rasmussen.
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