DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 8 July 2026.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 8 July 2026, Applicant argues Huebsch’422 fail to teach “the tubular body includes attached fibers positioned at an end of the tubular body that promote clotting”, as required by claims 1, 8 and 13. Applicant argues that Huebsch’422’s teaching that the entire device can be covered with or coated in a fabric that promotes tissue ingrowth or block blood shunting (column 7, lines 44-48) is not the same as a fiber that promotes clotting.
The Office disagrees. The specification provides no guidance or explanation of what characteristics the attached fibers must have to promote clotting. Paragraph [0017] of the specification, as filed, on discloses: “Clotting is further improved, in some embodiments, by attaching fibers 120 as shown in FIG. 1C”.
Therefore, under broadest reasonable interpretation, the claim is anticipated by any fiber positioned at the end of the tubular body. In this case, Huebsch’422 discloses fibers attached at an end of the tubular body. Further, Huebsch’422’s disclosure that the fiber may promote tissue ingrowth is evidence that it will not resist or repel blood/tissue.
Applicant argues that it would not be obvious to modify Huebsch’422 with fibers that promote clotting. However, the rejection does not suggest modifying Huebsch’422 in this way – Huebsch’422 discloses fibers and is not being modified to have fibers which promote clotting. Based on the lack of detail provided by Applicant, any fiber that isn’t coated with an anti-thrombotic coating, would anticipate or render obvious the limitation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 24-26 each recite “wherein the attached fibers are positioned only at the end of the tubular body”. MPEP 2173.05(i) states ” Any negative limitation or exclusionary proviso must have basis in the original disclosure.” However, the original disclosure does not exclude fibers placed elsewhere. Paragraph [0006] of the specification, as filed, states: “the tubular body includes a plurality of fibers attached thereto. The fibers, in turn, are optionally attached to an end of the tubular body.“ Paragraph [0017] of the specification states: “Clotting is further improved, in some embodiments, by attaching fibers 120 as shown in FIG. 1C”. The specification does not disclose the fibers are only attached to the end of the tubular body.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huebsch et al. (US Patent 5,853,422).
Claim 1: Huebsch’422 discloses a system configured to occlude an artery or vein of a patient (column 2, lines 33-36), the system comprising:
a tubular body (10; Figure 2), the tubular body having a sidewall (12), the sidewall including a plurality of cuts (12, 12) extending partially about a circumference of the sidewall and extending longitudinally along a portion of a length of the sidewall (Figure 2),
the tubular body further comprising at least two circumferential regions (A, B, as identified in the annotated copy of Figures 2, 3 below) defined by termini of the plurality of cuts (Figure 3-5; column 4, lines 23-26),
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wherein the tubular body is configured to move between an elongated configuration characterized by a first distance between the circumferential regions (Figure 2) and a shortened configuration in which the circumferential regions are separated by a second distance less than the first distance (Figure 4) such that a plurality of portions of the sidewall between the plurality of cuts of a first of the at least two circumferential regions are displaced radially outward to define a first plurality of leaves (22) and a plurality of portions of the sidewall radially between the plurality of cuts of a second of the at least two circumferential regions are displaced radially outward to define a second plurality of leaves (22).
In the shortened configuration (Figures 3, 4) the distal most leaves of the first and second plurality of leaves are configured to secure the tubular body within the artery or vein (Figures 4 show the expansion of the leaves, this serves to anchor the expanded leaves).
Huebsch’422 discloses the entire device can be covered with or coated in fabric to promote tissue ingrowth or block blood shunting (column 7, lines 44-48). Since the entire device can be covered with fabric, the end of the tubular body also includes fibers.
Claim 2: Huebsch’422 discloses the sidewall includes a shape memory material (column 3, lines 64-67).
Claim 3: Huebsch’422 discloses the tubular body assumes the elongate configuration with when radially constrained within a catheter (Figure 5a shows the elongate configuration of 10’ in catheter 40’) and assumes the deployed configuration when unconstrained (Figure 5a shows the deployed configuration of 10 outside of catheter 40).
Claim 24: Huebsch’422 discloses the attached fibers are positioned only at the end of the tubular body (column 7, lines 44-48 states: “the entire closure device or the portion thereof exposed to the heart chambers may be covered or coated with a fabric…”).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8, 10, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Huebsch’422 in view of Beer et al. (US Patent Publication 2003/0139819).
Claim 8, 10: Huebsch’422 teaches the tubular body with a plurality of cuts and attached fiber which promotes clotting, as described in the rejection to claim 1 above. See the rejection to claim 1 above for more details.
Huebsch’422 further discloses a microcatheter (40) that has an inner diameter greater than the outer diameter of the tubular body in the elongated configuration (Figure 5a) and less than the outer diameter of the tubular body in the expanded configuration (Figures 5a).
Huebsch’422 fails to disclose a guide wire.
However, the use of a guide wire to advance a delivery catheter through the body to a desired location are well known and established in the prior art. In particular, Beer’819 teaches a septal defect closure device (paragraph [0053], Figure 4, 5) that is similar to Huebsch’422. Beer’819 teaches delivering the closure device through a catheter (101) which is guided to the heart via guidewire (143). Guidewires are well known to aid in guiding a catheter to a target location while minimizing trauma. Beer’819’s guidewire has an outer diameter which is less than the inner diameter of the tubular body in the elongated configuration (Figures 26-29 show the guidewire passing through the inner lumen of the tubular body).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Huebsch’422 with a guidewire, as taught by Beer’819, in order to aid in the process of delivery.
Claim 25: Huebsch’422 teaches the attached fibers are positioned only at the end of the tubular body (column 7, lines 44-48 states: “the entire closure device or the portion thereof exposed to the heart chambers may be covered or coated with a fabric…”).
Claims 11, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Huebsch’422 in view of Beer’819, as applied to claim 8, further in view of Callaghan et al. (US Patent Application 2006/0122647).
Claim 11, 12: Huebsch’422 does not teach a pushrod.
Like Huebsch’422, Callaghan’647 teaches a PFO closure device (Figures 2a-2d) in the form of a tubular element with two sets of cuts which expand to have a pair of leaves on for placement on both sides of the septum (see Figures 2a-2d and Figure 4d).
Callaghan’647 further discloses passing the tubular body through a microcatheter (356, Fig. 21) and advancing the tubular member with a pushrod (348) that pushes the tubular member out of the microcatheter (paragraph [0104]). The pushrod has an outer diameter greater than the inner diameter of the tubular body of the PFO closure device (Figure 22). Callaghan'647 teaches the pushrod (348) has a structure (346) that interlocks with structure (314) on the tubular body in order to provide accurate delivery of the occluder to the desired delivery location and allow for controlled deployment so the position of the device can be changed during deployment (paragraph [0103]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Huebsch’422, with a pushrod that interlocks with the tubular body, as taught by Callaghan'647, in order to provide the stated advantages.
Claims 13, 14, 15, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Huebsch’422 in view of Coleman et al. (US Patent Application 2007/0185529) as evidenced by Yencho et al. (US Patent Application 2004/0243155).
Claim 13, 14: Huebsch’422 teaches a method of occluding blood flow through an artery or vein of a patient (column 2, lines 33-36), comprising:
inserting a system into the artery or vein of the patient (Figure 5a and column 2, lines 33-36), the system comprising:
a tubular body (10), the tubular body having a sidewall, the sidewall including a plurality of cuts extending partially about a circumference of the sidewall and extending longitudinally along a portion of a length of the sidewall, the tubular body further comprising at least two circumferential regions defined by termini of the plurality of cuts (Figures 2-4; see the rejection to claim 1 above for more details), and
deploying the tubular body within the artery or vein by moving the tubular body between an elongated configuration characterized by a first distance between the circumferential regions (Figure 2) and a shortened configuration in which the circumferential regions are separated by a second distance less than the first distance (Figure 4), such that a plurality of portions of the sidewall between the plurality of cuts of a first of the at least two circumferential regions are displaced radially outward to define a first plurality of leaves (22) and a plurality of portions of the sidewall between the plurality of cuts of a second of the at least two circumferential regions are displaced radially outward to define a second plurality of leaves (22) (Figure 4, 5a-5b), wherein the tubular body includes attached fibers to promote tissue ingrowth or block blood shunting (column 7, lines 44-48 states the entire device can be covered with or coated in fabric to promote tissue ingrowth or block blood shunting; since the entire device is covered with fabric, the end of the tubular body also includes fibers.)
Huebsch’422 teaches the cuts can be helical (column 4, lines 25), but does not teach the pairs of leaflets twist in opposite directions.
Like Huebsch’422, Coleman’529 is directed towards an expandable closure device including a tubular body (12) including a first and second plurality of cuts (14a, 14b) that extend longitudinally and radially along a portion of the length of the sidewall such that the tubular body is configured to move between an elongated configuration (Figure 1a) and a deployed configuration (Figure 1c, 1d) in which the cuts define a first and second plurality of leaves (16a, 16b). Coleman’529 teaches the cuts may extend in different directions, which results in the first leaves twisting in a first orientation that is opposite to the direction of the second leaves (paragraph [0043]) in order to maximize the contact area between the leaves and the opening the device is intended to close (paragraph [0044]) and to allow for controlled expansion of each set of leaves (paragraph [0043]). It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to arrange the cuts so they extend in different directions, as taught by Coleman’529, in order to provide the stated advantages.
While it is implicitly understood that Coleman’529 teaches a degree of twist in opposite directions, Coleman’529 does not explicitly show that the cuts which extend in opposite radial directions would result in leaves having a degree of twist in opposite directions.
Yencho’155 is directed towards a closure device having a similar structure to that of Huebsch’422 and Coleman’529 because it is a tubular member (110) having a plurality of cutouts which are rotated in order to collapse the remaining flanges in order to create leaves (121) (paragraph [0066]. Yencho’155 shows that the cutouts extending longitudinally and radially along the tube, as in Coleman’529, and shows that in the collapsed configuration, which the leaves are formed, the leaves have a degree of twist (see Figure 16). This teaching by Yencho’155 shows the leaves in the device of Huebsch’422 in view of Coleman’529 have a degree of twist in the deployed configuration that is opposite from one another.
In the resulting device of Huebsch’422 in view of Coleman’529 and evidenced by Yencho’155, turbulent flow through the tubular body will be increased upon deployment because the resulting structure is the same as the claimed structure and one of ordinary skill in the art both devices to perform similarly. See MPEP 2112.
Claim 15: Huebsch’422 teaches the: inserting the tubular body in the elongated configuration through a microcatheter (40) into a body lumen of a patient (Figure 5a, 5b); and
advancing the tubular body through a distal opening in the microcatheter so the tubular body assumes the deployed configuration when advanced outside of the microcatheter (column 4, lines 27-46 and Figures 5a, 5b).
Claim 26: Huebsch’422 teaches the attached fibers are positioned only at the end of the tubular body (column 7, lines 44-48 states: “the entire closure device or the portion thereof exposed to the heart chambers may be covered or coated with a fabric…”).
Claims 16, 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Huebsch’422 in view of Coleman’529 as evidenced by Yencho’155, as applied to claim 15, further in view of Beer’819.
Claim 16: Huebsch’422 fails to disclose a guide wire.
However, the use of a guide wire to advance a delivery catheter through the body to a desired location are well known and established in the prior art. IN particular, Beer’819 teaches a septal defect closure device (paragraph [0053], Figure 4, 5) that is similar to Huebsch’422. Beer’819 teaches delivering the closure device through a catheter (101) which is guided to the heart via guidewire (143). Guidewires are well known to aid in guiding a catheter to a target location while minimizing trauma. Beer’819’s tubular body is advanced over the guidewire and through the catheter (Figures 26-29 show the guidewire passing through the inner lumen of the tubular body).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Huebsch’422 with a guidewire, as taught by Beer’819, in order to aid in the process of delivery.
Huebsch’422 fails to disclose a pushrod.
Like Huebsch’422, Kladakis’180 teaches a PFO closure device (Figures 2e-2h) in the form of a tubular element with two sets of cuts which expand to have a pair of leaves on for placement on both sides of the septum (see Figures 2e-2h and Figure 8). Similarly, Kladakis’180 teaches delivering the closure device though a catheter (161; Figure 7a). There is a pushrod (169) inside the catheter (161) to aid in pushing the closure device (20) out of the catheter.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide Heubsch’422 with a pushrod, as taught by Kladakis’180, in order to aid in pushing the closure device out of the catheter at the target location.
Claim 19, 21: Huebsch’422 teaches a step of inserting an second implant in the body lumen adjacent to the tubular body (Huebsch’422 teaches inserting two occlusion devices; Figures 5a, 5b).
Claim 20: The second implant (40’) of Huebsch’422 is considered to be an embolic particle because it blocks flow (column 7, lines 44-48).
Claims 17, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Huebsch’422 in view of Coleman’529 as evidenced by Yencho’155 in view of Beer’819, as applied to claim 16, further in view of Callaghan’647.
Claims 17, 18: Huebsch’422, as modified, teaches the limitations of claims 17 and 18, but fails to detail how the tubular member exits the microcatheter (40).
Like Huebsch’422, Callaghan’647 teaches a PFO closure device (Figures 2a-2d) in the form of a tubular element with two sets of cuts which expand to have a pair of leaves on for placement on both sides of the septum (see Figures 2a-2d and Figure 4d).
Callaghan’647 further discloses passing the tubular member through a microcatheter (242) and using a pushrod (244, 256) to move the tubular member out of the microcatheter. In particular, Callaghan’647 teaches advancing the tubular member out of distal opening by retracting the microcatheter (“F3” in Figure 11, paragraph [0097]) and advancing the pushrod towards the distal opening ("F4"). Callaghan’647 teaches this method is advantageous because it holds the tubular member in a stationary position during delivery (paragraphs [0096], [0097]). It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Huebsch’422 by advancing the pushrod and withdrawing the microcatheter, as taught by Callaghan'647, in order to provide the stated advantages.
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 1-3, 6, 8 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10-20 of U.S. Patent No. 11,432,821. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘821 patent, as outlined in the chart below:
Claims of present application 17/885117
Anticipated by claims of 11,432,821
1
1
2
2
3
3
6
1
8
10
10
10
11
11
12
12
13
14
14
14
15
15
16
16
17
17
18
18
19
19
20
20
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 9 September 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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