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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/18/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 2/18/26. The claims 1-15 are pending. The claims 1 and 13 are amended. Claims 14 and 15 are withdrawn.
Response to Arguments
Applicant’s amendments, filed 2/18/26 have not overcome the double patenting rejection of claim 1 as being unpatentable over claim 1 of U.S. 11,129,622 in view of Center (US2016/0331382); and the double patenting rejection of claims 1 and 8 as being unpatentable over claims 1 and 13 of U.S. 11,826,052 in view of Center (US2016/0331382). The rejections have been maintained.
Applicant’s arguments, filed 2/18/26 with respect to the rejections of claims 1-3, 5-10 under 35 U.S.C. 102(a)(1) as being anticipated by Center (US2016/0331382) have been fully considered but they are not persuasive. Applicant argues, the amendment of claim 1 to recite “a first axis extending from a center of the center frame portion through the starting point is angularly displaced from a second axis extending from the center of the center frame portion through the end point” is not taught by Center. Examiner disagrees, as stated in the rejection below, Center discloses a first axis as shown in annotated Fig. 7-1, that extends from a center of the center frame portion through the starting point (where the starting point is the start of the elongate member 704 that is curved) is angularly displaced from a second axis as shown in annotated Fig. 7-2, that extends from the center of the center frame portion through the end point (end point is at the end of the elongate member 704). Where the first axis is angularly displaced from the second axis as shown in annotated Fig. 7-2, since the starting point is selected at a curved portion of the elongate member 704. Otherwise, the first axis is angularly displaced from the second axis when the elongate members are bent or flexed orthogonal to longitudinal axis as the device is manipulated to fill the space to be occluded. Therefore the rejection has been maintained.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11129622 in view of Center (US2016/0331382). Both claim 1 of the application and claim 1 of ‘622 recite a device for placement in vessels, appendages, and openings in a body, the device comprising:
a frame having a plurality of elongate members, the frame including:
a substantially uniform proximal end (face having pre-loaded flat configuration) of the frame having (i) a center frame portion (center frame hub) arranged at the proximal end and (ii) face portions of the plurality of elongate members extending from the center frame portion and including a curved pattern (plurality of arcs) arranged substantially within a first plane approximately perpendicular to a longitudinal axis of the frame; wherein the face portions of the plurality of elongate members each include a starting point at the center frame portion and an end point defining a perimeter of the proximal end (elongate members extend from center frame hub to the body portion that defines the perimeter), wherein a first axis extending from a center of the center frame portion through the starting point is angularly displaced from a second axis extending from the center of the center frame portion through the end point (the elongate members are configured to bend or flex orthogonal to longitudinal axis);
a body portion;
a membrane coupled to at least the substantially uniform proximal end of the frame.
‘622 does not claim a coating arranged on at least a portion of the membrane configured to minimize the thrombogenic response of blood contact with the membrane. Center, in the same field of endeavor, teaches an occlusion device with a frame covered by a membrane, a coating applied to membrane ([0101]). The coating arranged on at least a portion of the membrane configured to minimize the thrombogenic response of blood contact with the membrane ([0101]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the membrane of ‘622 to include a coating in order to provide resistance to thrombosis to the occlusive device ([0101]).
Claims 1 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 11826052 in view of Center (US2016/0331382). Both claim 1 of the application and claim 1 of ‘052 recite a device for placement in vessels, appendages, and openings in a body, the device comprising:
a frame having a plurality of elongate members, the frame including:
a substantially uniform proximal end (proximal face portion) of the frame having (i) a center frame portion (center frame hub) arranged at the proximal end and (ii) face portions of the plurality of elongate members (plurality of curved elongated members) extending from the center frame portion and including a curved pattern arranged substantially within a first plane approximately perpendicular to a longitudinal axis of the frame; wherein the face portions of the plurality of elongate members each include a starting point at the center frame portion and an end point defining a perimeter of the proximal end (elongate members extend from center frame hub to the body portion that defines the perimeter), wherein a first axis extending from a center of the center frame portion through the starting point is angularly displaced from a second axis extending from the center of the center frame portion through the end point (the elongate members are configured to bend or flex orthogonal to longitudinal axis);
a body portion;
a membrane coupled to at least the substantially uniform proximal end of the frame.
‘052 does not claim a coating arranged on at least a portion of the membrane configured to minimize the thrombogenic response of blood contact with the membrane. Center, in the same field of endeavor, teaches an occlusion device with a frame covered by a membrane, a coating applied to membrane ([0101]). The coating arranged on at least a portion of the membrane configured to minimize the thrombogenic response of blood contact with the membrane ([0101]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the membrane of ‘052 to include a coating in order to provide resistance to thrombosis to the occlusive device ([0101]).
Claim 8 of the application and claim 13 of ‘052 both recite wherein the face portions of the plurality of elongate members include a first curved section, a second curved section, and an inflection point between the first curved section and the second curved section within the proximal end of the frame.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Center (US2016/0331382)
Regarding claim 1, Center discloses a device (700) for placement in vessels, appendages, and openings in a body (see Abstract), the device comprising:
a frame (708) having a plurality of elongate members (704), the frame including:
a substantially uniform proximal end of the frame (the proximal end of the frame is interpreted as uniform by extending to a center 702 in a single plane, see Fig. 7, [0094]) having a center frame portion (702) arranged at the proximal end and face portions of the plurality of elongate members extending from the center frame portion (face portions are interpreted as the elongate members 704 that extend from 702, see Fig. 7) and including a curved pattern (curvature of elongate members 704, [0094], see Fig. 7) arranged substantially within a first plane approximately perpendicular to a longitudinal axis of the frame (see Fig. 7, [0094]), wherein the face portions of the plurality of elongate members each include a starting point at the center frame portion (see annotated Fig. 7-1, where the starting point of the elongate member 704 is selected at the initial curvature from the center frame portion) and an end point defining a perimeter of the proximal end (see annotated Fig. 7-1, where ends of the elongate members 704 extend radially outward and define a perimeter as shown in Fig. 7), wherein a first axis (see annotated Fig. 7-1) extending from a center of the center frame portion through the starting point (first axis shown in annotated Fig. 7-1 extends from the starting point) is angularly displaced from a second axis extending from the center of the center frame portion through the end point (first axis is angularly displaced from the second axis as shown in annotated Fig. 7-2 at least if the starting point is selected at a curved portion of the elongate member 704; otherwise, the first axis is angularly displaced from the second axis when the elongate members are bent or flexed orthogonal to longitudinal axis as the device is manipulated to fill the space to be occluded);
a body portion (706);
a membrane (membrane 710, [0100]) coupled to at least the substantially uniform proximal end of the frame (see Fig. 7); and
a coating (coating applied to membrane, [0101]) arranged on at least a portion of the membrane configured to minimize the thrombogenic response of blood contact with the membrane (membrane may be modified to be resistant to thrombosis, [0101]).
PNG
media_image1.png
552
692
media_image1.png
Greyscale
PNG
media_image2.png
552
692
media_image2.png
Greyscale
Regarding claim 2, Center discloses the device of claim 1, wherein the coating comprises heparin configured to lessen blood coagulation along the membrane coupled to at least the substantially uniform proximal end of the frame ([0101]).
Regarding claim 3, Center discloses the device of claim 1, wherein the coating is configured to decrease platelet adhesion to an exterior surface of the membrane coupled to at least the substantially uniform proximal end of the frame (membrane is resistant to thrombosis, and therefore would prevent platelet adhesion, [0101]).
Regarding claim 5, Center discloses the device of claim 1, wherein the plurality of elongate members are configured to angularly displace the center frame portion by between about 30 degrees and about 45 degrees in response to a compressive force applied to the body portion of the frame (the elongate members 704 are configured to flex or bend and are therefore capable of displacing the center frame by between 30 degrees to about 45 degrees in response to a compressive force, [0098]).
Regarding claim 6, Center discloses the device of claim 1, wherein the plurality of elongate members are configured to angularly displace the center frame portion by between about 30 degrees and about 45 degrees in response to the compressive force reducing the circumference of the body portion of the frame by between about 20% and about 50% (the elongate members 704 are configured to flex or bend and are therefore capable of displacing the center frame by between 30 degrees to about 45 degrees in response to a compressive force that reduces the circumference of the body portion by about 20% to about 50%, [0098]).
Regarding claim 7, Center discloses the device of claim 6, wherein the plurality of elongate members are configured to angularly displace the center frame portion and maintain the center frame portion approximately aligned with a longitudinal axis of the frame in response to the compressive force (the elongate members 704 are maintained in the common plane when flexed, [0098]).
Regarding claim 8, Center discloses the device of claim 1, wherein the face portions of the plurality of elongate members include a first curved section, a second curved section, and an inflection point between the first curved section and the second curved section within the proximal end of the frame (see annotated Fig. 7).
PNG
media_image3.png
465
519
media_image3.png
Greyscale
Regarding claim 9, Center discloses the device of claim 1, wherein the body portion of the frame includes a shoulder portion including first curved portions of the plurality of elongate members transitioning from the first plane to align approximately parallel with the longitudinal axis of the frame (see annotated Fig. 7-3, where the first curved portions are at the transition to the body portion extends along the parallel to the longitudinal axis of the frame), and a first body portion (see annotated Fig. 7-3) including a first plurality of cells (the remainder of the cells within the row as shown in annotated Fig. 7-3) arranged circumferentially about the frame formed by first body portions of the plurality of elongate members (see annotated Fig. 7-3), a hip portion including second curved portions of the plurality of elongate members transitioning the frame inwardly toward the longitudinal axis of the frame (see annotated Fig. 7-3), and a second body portion including a second plurality of cells arranged circumferentially about the frame.
PNG
media_image4.png
485
624
media_image4.png
Greyscale
Regarding claim 10, Center discloses the device of claim 9, wherein the membrane includes a plurality of openings arranged circumferentially about the frame (membrane 710 can include openings, [0104]).
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Center (US2016/0331382) as applied to claim 1 above, and further in view of Boekstegers (US2002/0032478).
Regarding 4, Center discloses the device of claim 1; yet, does not explicitly disclose wherein the coating is a carmeda heparin coating. Boekstegers teaches stent implants that may be coated to minimize a biological reaction (see Abstract). Where the coating may include heparin such as Carmeda heparin ([0029]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the coating be a carmeda heparin coating as taught by Boekstegers in order to provide a heparin based coating that is able to withstand aggressive blood flow and flexure ([0029]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Center (US2016/0331382).
Regarding claim 11, Center discloses the device of claim 10; yet, does not explicitly disclose wherein the frame includes a plurality of anchors arranged at the hip portion configured to rotate relative to and toward the longitudinal axis and pass through the plurality of openings. Center according to the embodiment of Figs. 5A-5B teaches an occlusive device with frame 500, similar to the frame 708, but includes anchors 524 ([0086]) and also can include a membrane ([0086]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the frame 708 to include anchors as taught by the embodiment of Figs. 5A-5B in order to contact a vessel or appendage and hold the occlusive device in place ([0084]). Where one having ordinary skill in the art would understand that the anchors need to pass through the membrane in order to function as intended, where the membrane does include openings and the anchors could pass through the openings to contact tissue by rotating the anchors relative to and toward the longitudinal axis.
Regarding claim 12, Center makes obvious the device of claim 11, wherein the plurality of anchors are configured to rotate and pass through the plurality of openings in response to constriction of the substantially uniform proximal end of the frame (the anchors of the modified invention are capable of passing through the openings in response to a constriction of the proximal end of the frame).
Regarding claim 13, Center makes obvious the device of claim 12, wherein the plurality of anchors are configured to rotate and pass through the plurality of openings in in response to the frame being arranged in a delivery configuration to avoid contact between an anchor tip and a delivery sheath (the anchors of the modified invention are capable of passing through some openings in response to the frame being arranged in a delivery configuration).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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, Thomas Barrett can be reached on (571)272-4746. 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.
/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights