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 .
Election/Restrictions
Applicant’s election without traverse of Invention I and Species B in the reply filed on 02/09/2026 is acknowledged.
Claims 6-7, 9 and 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/09/2026.
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: “sealing member” in claim 1.
Para. [0076] of the instant spec. describes the “sealing member” as fabric. “Sealing member” uses the generic placeholder “member” coupled with the term “sealing”, which is functional in that the limitation alternatively recites a member for sealing, and the term “member” is not preceded by a structural modifier since the term “sealing” does not imply any structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5, 8 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan (US 2006/0281965 A1).
Regarding claim 1, Khairkhahan discloses (see abstract; paras. [0040]-[0063]; figs. 1-18) an occlusive implant (10, fig. 1), comprising:
an expandable framework (13, para. [0040]; fig. 1) configured to shift between a collapsed configuration and an expanded configuration (para. [0040]; figs. 11a-e), the expandable framework includes a plurality of anchor members (27, para. [0045]; figs. 2 and 7) extending radially outward from the expandable framework (figs. 2-3);
an occlusive member (inner layer of membrane 11, para. [0041]; figs. 7 and 18) disposed along at least a portion of the expandable framework (figs. 1-2 and 17); and
a sealing member (outer layer of membrane 11) disposed along the occlusive member (figs. 7 and 17-18),
wherein at least a portion of the plurality of anchor members extend through an aperture formed in the occlusive member (aperture depicted in fig. 7, see also strand 19 sealing periphery of membrane, paras. [0041] and [0045]; figs. 2-3 and 7).
Regarding claim 2, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member extends radially outward from the occlusive member (figs. 7 and 18).
Regarding claim 3, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric (para. [0015]).
Regarding claim 4, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member extends around only a portion of the outer surface of the occlusive member (considered to extend only around portions of inner layer of membrane 11 due to presence of ribs 14 and swellable bodies 70 located in between layers, figs. 2-3, 7 and 18).
Regarding claim 5, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member extends circumferentially around the outer surface of the occlusive member (figs. 1-3).
Regarding claim 8, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the sealing member includes an expandable element (70, para. [0060]; figs. 17-18) disposed along a portion of the sealing member (fig. 18).
Regarding claim 10, Khairkhahan discloses the occlusive implant of claim 1. Khairkhahan further discloses wherein the expandable framework and the plurality of anchor members are formed from a unitary tubular member (considered to be consisting of a single base unit/element formed in a tubular shape similar to figs. 5-6 of the instant spec., note the limitation “formed from a unitary tubular member” is treated as a product by process limitation, in which determination of patentability is based on the product itself; since Khairkhahan discloses frame 13 and ribs 14 formed of a unitary structure, the limitation is considered to be met, see MPEP 2113).
Regarding claim 11, Khairkhahan discloses (see abstract; paras. [0040]-[0063]; figs. 1-18) a medical implant (10, fig. 1) for occluding a left atrial appendage (considered to be capable of occluding a left atrial appendage, since the device of Khairkhahan divides portions of the heart, para. [0054]), comprising:
an expandable framework (13, para. [0040]; fig. 1) configured to shift between a collapsed configuration and an expanded configuration (para. [0040]; figs. 11a-e);
a plurality of anchor members (27, para. [0045]; figs. 2 and 7) disposed along the expandable framework (figs. 2-3);
a covering (inner layer of membrane 11, para. [0041]; figs. 7 and 18) disposed along an outer surface of the expandable framework (figs. 1-2 and 17); and
a protrusion portion (outer layer of membrane 11) extending outward from the covering (figs. 7 and 17-18).
Regarding claim 12, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the covering is formed from a fabric (para. [0015]).
Regarding claim 13, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the covering extends along only a portion of the expandable framework (see figs. 5 and 7 depicting proximal and distal ends of ribs 14 not covered by membrane).
Regarding claim 14, Khairkhahan discloses the medical implant of claim 11. Khairkhahan further discloses wherein the protrusion portion extends circumferentially around an outer surface of the covering (figs. 1-3).
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 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 12,082,794 B2 to Onushko. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 11-13 would anticipate current claims 11-14.
18,829,096 claims
Corresponding U.S. 12,082,764 B2 claims
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11
12
12
13
11
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13
Claims 1-5, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 of U.S. Patent No. 12,082,794 B2 to Onushko in view of Khairkhahan.
Regarding claim 1, Onushko claims the implant of claim 1 (claim 8), but fails to claim wherein at least a portion of the plurality of anchor members extend through an aperture formed in the occlusive member.
Khairkhahan teaches wherein at least a portion of the plurality of anchor members (27) extend through an aperture formed in the occlusive member (aperture depicted in fig. 7, see also strand 19 sealing periphery of membrane, paras. [0041] and [0045]; figs. 2-3 and 7), for the purpose of engaging tissue to hold the device in a deployed position (paras. [0045] and [0050]-[0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein at least a portion of the plurality of anchor members extend through an aperture formed in the occlusive member, in order to engage tissue to hold the device in a deployed position, based on the teachings of Khairkhahan (paras. [0045] and [0050]-[0051]).
Regarding claim 2, Onushko (as modified) claims the implant of claim 2 (claim 8).
Regarding claim 3, Onushko (as modified) claims the implant of claim 3 (claim 8), but fails to claim wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric.
Khairkhahan teaches wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric (para. [0015]), for the purpose of forming the membrane of an appropriate flexible material (para. [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the occlusive member, the sealing member or both the occlusive member and the sealing member are formed from a fabric, in order to form the membrane of an appropriate flexible material, based on the teachings of Khairkhahan (para. [0015]).
Regarding claim 4, Onushko (as modified) claims the implant of claim 4 (claim 8), but fails to claim wherein the sealing member extends around only a portion of the outer surface of the occlusive member.
Khairkhahan teaches wherein the sealing member extends around only a portion of the outer surface of the occlusive member (considered to extend only around portions of inner layer of membrane 11 due to presence of ribs 14 and swellable bodies 70 located in between layers, figs. 2-3, 7 and 18), for the purpose of providing swellable bodies to seal the peripheral portion of the membrane against the patient’s heart wall (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member extends around only a portion of the outer surface of the occlusive member, in order to provide swellable bodies to seal the peripheral portion of the membrane against the patient’s heart wall, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 5, Onushko (as modified) claims the implant of claim 5 (claim 8), but fails to claim wherein the sealing member extends circumferentially around the outer surface of the occlusive member.
Khairkhahan teaches wherein the sealing member extends circumferentially around the outer surface of the occlusive member (figs. 1-3), for the purpose of sealing the peripheral portion of the membrane against a patient’s heart circumferentially around the implant (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member extends circumferentially around the outer surface of the occlusive member, in order to seal the peripheral portion of the membrane against a patient’s heart circumferentially around the implant, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 8, Onushko (as modified) claims the implant of claim 8 (claim 8), but fails to claim wherein the sealing member includes an expandable element disposed along a portion of the sealing member.
Khairkhahan teaches wherein the sealing member includes an expandable element (70, para. [0060]; figs. 17-18) disposed along a portion of the sealing member (fig. 18), for the purpose of sealing the peripheral portion of the membrane against a patient’s heart circumferentially around the implant (para. [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the sealing member includes an expandable element disposed along a portion of the sealing member, in order to seal the peripheral portion of the membrane against a patient’s heart circumferentially around the implant, based on the teachings of Khairkhahan (para. [0060]).
Regarding claim 10, Onushko (as modified) claims the implant of claim 10 (claim 9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 7780725 B2 to Haug, disclosing an everting heart valve including sacs filled with a hydrogel.
US 2014/0114402 A1 to Ahlberg, disclosing a valve prosthesis including a sealing element.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771