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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/17/2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 06/09/2026. As directed by the amendment: claim 1 has been amended, no additional claims have been cancelled and no new claims have been added. Thus, claims 1-15, and 19-21 are presently pending in this application, and currently examined in the Office Action.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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, 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.
Claims 1-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Callaghan (US PG Pub. 2007/0244518), as previously disclosed, in view of Center et al. (US PG Pub. 2015/0005810), as previously disclosed, hereinafter Center.
Regarding claims 1-5, 7, 8, 12 and 13, Callaghan discloses an apparatus (20/1170), illustrated in Figures 2A-2H and 14A-14D, for implantation in an opening of a tissue ([0047], Lines 1-4) comprising a support structure including/defined by a plurality of filaments (32/42/232/242/1161), wherein the plurality of filaments are bio-absorbable an configured to degrade within a time period, the support structure including a proximal disk (40/1142), a distal disk (30/1132), and a waist (22/1122), wherein the plurality of filaments define a hub, specifically a proximal hub (44/1144) arranged at a proximal end of the plurality of filaments, a distal hub (39/1139) arranged at a distal end of the plurality of filaments, and a central ring hub (22/1122) positioned about the waist (22/1122), illustrated in Figures 2A-2H and 14A-14D, wherein the waist (22/1122) is operable to be positioned through the opening of the tissue ([0053]; [0055]; [0087], Line 5; [0102]; [0104] & [0105]); and a membrane/tissue scaffold including a first layer (on the outside face) and a second layer (on the inside face) arranged about the plurality of filaments such that the first and second layers sandwich the plurality of filaments, the membrane/tissue scaffold being configured to promote tissue ingrowth into the membrane/tissue scaffold and tissue encapsulation of at least a portion of the membrane, wherein the membrane/tissue scaffold includes a surface structure configured to stabilize the support structure that fragments of the support structure are restricted from movement from a treatment site, wherein the membrane/tissue scaffold is configured to promote healthy tissue growth or partial tissue encapsulation, remaining with the tissue after degradation of the absorbable filaments, and to contain the support structure of the apparatus in response to the degradation of the plurality of filaments, and wherein the plurality of filaments are configured to apply appositional forces against a septum (14/16) such that the membrane facilitates tissue ingrowth close to the opening (18), and the waist (22) is configured to hold open, and structurally enhance, the space/opening, into which the apparatus is implanted, illustrated, for example, in Figures 9H and 10A ([0055]; [0087]; [0094] & [0100]); but does not specifically teach that the plurality of filaments are helically wound together in a plurality of directions.
However, Center teaches an apparatus for impanation in an opening of a tissue, in the same field of endeavor, comprising a disc-shaped member (710) including/defined by a plurality of filaments (713,715) which are helically wound together in a plurality of directions, illustrated in Figure 11; the filaments being helically wound together in a plurality of directions allows for expansion of the apparatus/disc-shaped member in a balanced manner, reducing or eliminating frame malformations ([0145], Lines 1-6; [0146], Lines 1-3 & [0147], Last 8 Lines).
In view of the teachings of Center, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the plurality of filaments, of the support structure of the apparatus of Callaghan, to be helically wound together in a plurality of directions, in order to allow the support structure/apparatus to expand in a balanced manner, reducing or eliminating frame/structure malformations, as taught by Center.
Regarding claim 6, Callaghan in view of Center disclose the apparatus of claim 5, wherein Callaghan further teaches an elastic tensile member/string (137) coupled to the proximal hub (44) and the distal hub (39) and within the waist (22), illustrated in Figures 6A-6C, the elastic tensile member/string (137) being configured to bring the proximal disk (40) into apposition with a first side of a tissue wall (14/16) and the distal disk (30) into apposition with the second side of the tissue wall (14/16), illustrated in Figures 9H and 10A (Callaghan: [0091]; [0100]; [0101] & [0103], Last 5 Lines).
Regarding claim 9, Callaghan in view of Center disclose the apparatus of claim 7, wherein Center teaches a central hub (406) comprising winding filaments, illustrated in Figures 22A-23, the winding filaments allow the central hub to be flexible and permit rotation between the distal and proximal disks (Center:[0166]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the central hub, of the apparatus of Callaghan in view of Center, to comprise winding of filaments, in order to allow the central hub to be flexible and permit rotation between the distal and proximal disks, as taught by Center.
Regarding claim 10, Callaghan in view of Center disclose the apparatus of claim 7, wherein Callaghan further teaches the central hub (22) is a band of material operable to maintain a diameter of the waist during stretching of the apparatus, illustrated in Figures 2A-2H and 14A-14D (Callaghan: [0052]).
Regarding claim 11, Callaghan in view of Center disclose the apparatus of claim 1, wherein Callaghan further teaches the waist (22) is defined by central portions of the plurality of absorbable filaments (32/42/232/242), illustrated in Figures 2A-2H and 14A-14D (Callaghan: [0052] & [0102]).
Regarding claim 15, Callaghan in view of Center disclose the apparatus of claim 1, wherein Callaghan further teaches end portions of the plurality of filaments (1161) are bonded/formed together to define the hub (1144/1139/1122), illustrated in Figures 14A-14D (Callaghan: [0102], Lines 14-18).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Callaghan in view of Center as applied to claim 1 above, and further in view of Mazzocchi et al. (US PG Pub. 2005/0119690), as previously disclosed, hereinafter Mazzocchi.
Regarding claim 14, Callaghan in view of Center disclose the apparatus of claim 1, wherein Callaghan further teaches the hub comprising first ends (1144/1139) of the plurality of filaments (1161), illustrated in Figures 14A-14D; but does not specifically disclose the hub including a band of material arranged about the first ends.
However, Mazzocchi teaches an apparatus, in the same field of endeavor, comprising a hub including a band of material (272/274) arranged about the ends, illustrated in Figure 11 ([0120]); the band of material can comprise a radiopaque material in order to increase visibility for fluoroscopic observation ([0119]).
In view of the teachings of Mazzocchi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the hub(s) at the first ends of the plurality of filaments, of the apparatus of Callaghan in view of Center, to include a band of material comprising radiopaque material in order to increase visibility for fluoroscopic observation to aid in delivery and placement, as taught by Mazzocchi.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Callaghan in view of Center as applied to claim 1 above, and further in view of Cahill (US PG Pub. 2016/0249899), as previously disclosed, hereinafter Cahill’899.
Regarding claim 19, Callaghan in view of Center disclose the apparatus of claim 1, wherein Callaghan further teaches a catch member (131), including an absorbable material (Callaghan: [0090], Lines 20-23); but does not specifically disclose the catch member includes a threaded end configured to thread with a corresponding threaded member on a delivery system.
However, Cahill’899 teaches an apparatus (70), in the same field of endeavor, comprising a catch member (100) including a threaded end (130) configured to thread with a corresponding threaded member on a delivery system (200), illustrated in Figures 9-12 ([0059]).
In view of the teachings of Cahill’899, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the catch member, of the apparatus of Callaghan in view of Center, to have a threaded end configured to thread with a corresponding threaded member on a delivery system, since this is a well-known, art equivalent, mechanism to deliver, expand and lock the apparatus in an appropriate location, as taught by Cahill.
Regarding claim 20, Callaghan in view of Center and Cahill’899 disclose the apparatus of claim 19, wherein Callaghan further teaches the catch member (131) is flexible in a mid- body portion to allow conformability of the disks (Callaghan: [0091] – to clarify, the catch member comprises delivery string 137 which is flexible).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Callaghan in view of Center and Cahill’899 as applied to claim 19 above, and further in view of Cahill et al. (US PG Pub. 2007/0250081), as previously disclosed, hereinafter Cahill’081.
Regarding claim 21, Callaghan in view of Center and Cahill’899 disclose the apparatus of claim 19, but do not specifically disclose the catch member is spring loaded to maintain apposition of the disks; though Callaghan does state that catch member (131) “may take a variety of forms” (Callaghan: [0091], Lines 1-2).
However, Cahill’081 teaches an apparatus, in the same field of endeavor, wherein it comprises a catch member (50) is spring loaded to maintain apposition of the disks, illustrated in Figures 9A-14 ([0019]; [0085]; [0088] & [0089]).
In view of the teachings of Cahill’081, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the catch member, of the apparatus of Callaghan in view of Center and Cahill’899, to be spring loaded to maintain apposition of the disks, since this is a known form of a catch member to deliver and expand the device/maintain apposition of the disks, as taught by Cahill’081.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-12 and 28 of U.S. Patent No. 11,911,272, hereinafter ‘272, in view of Center. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose an occluding apparatus, for implantation in an opening, comprising a support structure including a plurality of filaments configured to degrade within a time period, the support structure including a proximal disk, a distal disk, and a waist, wherein the waist is operable to be positioned through the opening; and a membrane including first and second layers arranged about the plurality of filaments such that the first and second layers sandwich the plurality of filaments, the membrane being configured to promote tissue ingrowth into the membrane/tissue encapsulation of at least a portion of the membrane to maintain the support structure in response to the degradation of the filaments, and wherein the plurality of filaments define a hub; but the claims of '272 do not disclose the plurality of filaments are helically wound together in a plurality of directions. However, Center teaches an apparatus for impanation in an opening of a tissue, in the same field of endeavor, comprising a disc-shaped member (710) including/defined by a plurality of filaments (713,715) which are helically wound together in a plurality of directions, illustrated in Figure 11; the filaments being helically wound together in a plurality of directions allows for expansion of the apparatus/disc-shaped member in a balanced manner, reducing or eliminating frame malformations (Center: [0145], Lines 1-6; [0146], Lines 1-3 & [0147], Last 8 Lines). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the plurality of filaments, of the occluding apparatus of the claims of '272, to be helically wound together in a plurality of directions, in order to allow the support structure/apparatus to expand in a balanced manner, reducing or eliminating frame/structure malformations, as taught by Center.
Response to Arguments
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive. Applicant arguses the rejection of independent claim 1 stating the newly added parameter of “the membrane includes a first layer and a second layer arranged about the plurality of filaments such that the first and second layers sandwich the plurality of filaments” is not show or described by Callaghan or Center. Examiner respectfully disagrees with Applicant’s assertion. Callaghan teaches that the membrane/tissue scaffold can be located on the outside face and inside face of the filaments of the discs of the distal and proximal sides (Callaghan: [0094], Lines 19-23); thus, clearly teaching the newly added parameter mentioned above. Hence, the rejection of independent claim 1 as being unpatentable over Callaghan in view of Center is deemed to be proper since all the structural limitations set forth in the claim are taught; therefore, the rejection stands.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 08/03/2026
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