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 .
Petition for Revival Granted
A petition under the unintentional provisions of 37 CFR 1.137(a) was filed on 16 August 2025 to revive the application. The Petition was GRANTED on 10 September 2025.
Formal Matters
Applicant’s response filed 11 August 2025 is acknowledged. Claims 16-22 are cancelled. Claims 1, 3, and 6-9 are amended. Claims 1-15 are under examination.
Objections/Rejections Withdrawn
The objections to the disclosure because of the following informalities: the specification contains 106 instances of the word “petal”, but also contains 2 instances of the word “pedal” (at ¶¶15 and 36), is withdrawn in light of Applicant’s amendments.
The objection to the drawings are withdrawn in light of Applicant’s Replacement Sheets filed on 8/11/2025.
The objections over claims 1, 3, 6-9 because of the following informalities: the claims recite the word “pedal” instead of “petal”, is withdrawn light of Applicant’s amendments to the claims.
The rejection of claims 1-5 and 10-15 under 35 U.S.C. 102(a)(1) as being anticipated by Olsen et al, US 20110022080 (27 January 2011) is withdrawn in light of Applicant’s amendments. However, modified rejections, necessitated by Amendment are set forth below.
Response to Declaration under 37 CFR 1.131(a)
The Declaration filed under 37 CFR 1.131(a) as a Statement of Common Ownership with US Patent Application Publication 20120283585A1 (13/368685) as being commonly owned by Ventrimend, Inc., along with a document for recordation of the assignment, has been fully considered, but is ineffective to overcome the Werneth et al., US 2012028385 (8 November 2012) reference. The Werneth ‘585 reference was published and publicly available 9 years prior to the earliest benefit date of the instant application of 22 June 2021. The Werneth reference was cited as a publication under 35 USC 102(a)(1). The Common Ownership exception [102(b)(2)(C)] only applies to prior art cited under 35 USC 102(a)(2) and does not apply to public disclosures under 35 USC 102(a)(1). See MPEP 717.02(b)(II).
The exceptions for prior art cited under 102(a)(1) are determined under 102(b)(1)(A) or 102(b)(1)(B) where the subject matter disclosure exception has a one-year grace period limitation. The Werneth reference was publicly available 9 years prior to the earliest effective filing date of the current application. Accordingly, the Declaration filed is not effective to disqualify the Werneth et al., US 2012028385 (8 November 2012) reference.
Applicant can find additional guidance as to the prior art common ownership exceptions at MPEP 717.01(a)(1)(A)(1), MPEP 717.02(b)(II), and https://www.uspto.gov/patents/first-inventor-to-file-fitf-resources then the link at “Comprehensive Training Slides (Summer 2013) [PDF]” at slide 63.
Response to Arguments
Applicant argues the claim interpretation used during examination stating that a review of the disclosure provides examines of asymmetrical petal anchors at ¶31 and ¶47 (Remarks, numbered p. 9). Applicant argues that the claimed petals are the individual petals shown in FIGs 6A-C and that there is no disclosure of “asymmetrical petals” associated with other figures (Remarks, numbered p. 9). Applicant’s arguments have been fully considered, but the broadest reasonable interpretation of “the anchor comprising asymmetrical petals” as recited in the Office Action mailed 1/16/2025 is maintained. Applicant’s response is noted and is included in the examiner’s interpretation under numbered paragraph 12, subparts (b) and (c). However, the examiner’s interpretive phrase included more than just the “asymmetrical petals”. It also included the anchor associated with them. Accordingly, the examiner still finds Applicant’s clarification helpful and notes that the examples in FIGs 6A, 6B, and 6C were included in the examiner’s broadest reasonable interpretation definition of “the anchor comprising asymmetrical petals”. The point of differentiation being that the phrase in the claims encompasses the open language “comprising”, indicating that the anchors may comprise more than the asymmetrical petals. The claim scope of the anchor is not limited to only the subject matter of the asymmetrical petals of FIGs 6A, 6B, and 6C. By way of example, the subject matter of claim 15, for example, which is ultimately dependent on claim 1, encompasses subject matter from FIGs 8 and 9. Accordingly the examiner must view the entirety of the composition of the anchors in its full scope, as written in the claim limitation.
Regarding Applicant’s arguments to the rejections under 35 USC 102(a)(1), Applicant argues that Olson does not include any mention of two or more sizes of petals (Remarks, numbered p. 12). Applicant argues that Olson does not describe what a flattened “flower petal” is. Applicant argues that there is no disclosure of two sizes of woven anchor. Applicant argues that the claim interpretation was incorrectly applied and that asymmetrical petals are disclosed in FIGs 6A-6C (Remarks, numbered p. 12). Applicant also argues that the amendments to claim 1 are not taught by Olson. Applicant’s arguments have been fully considered, but they are not entirely persuasive. However, in light of Applicant’s amendments, modified rejections are set forth below.
Regarding the rejections under 35 USC 103, Applicant argues that the claims are patentable over Olsen and that the Werneth reference is commonly owned and does not qualify as prior art. Applicant points to the attached Statement of Common Ownership. Applicant’s arguments have been fully considered, but they are not persuasive.
As stated above, the Statement of Common Ownership is ineffective against references cited in rejections under 35 USC 103 using 102(a)(1) dates. As explained above, the Werneth reference was published 9 years prior to the earliest effective filing date of the current application and was applied in the rejection under 35 USC 103 using a 102(a)(1) date as a publication more than one year before the earliest effective filing date of the current application.Applicant also does not argue the combination of the references. Accordingly, the arguments are not persuasive. However, in light of Applicant’s amendments, modified rejections are set forth below.
Claim Objections
Claim 15 is objected to because of the following informalities: line 2 contains a minor typographical error. Line 2 recites “shaft include or more”. It is believed that this should read “shaft includes one or more”, given the “the one or more engagement” language following the comma in line 2. Appropriate correction is required.
Objections/Rejections Maintained
Specification - Objection
The abstract of the disclosure remains objected to because the abstract exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Applicant’s response filed 8/11/2025 indicates that a replacement Abstract has been attached (Remarks, p. 3), but the page is blank and there is no other reference to an amended abstract elsewhere in the response. Accordingly, the objection is maintained for the reasons of record.
Claim Rejections Maintained and Modified – Necessitated by Amendment
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al, US 20110022080 (27 January 2011) in view of Werneth et al., US 20120283585 (8 November 2012) (both previously cited of record).
Regarding claim 1, Olsen teaches an implant for sealing a patent foramen ovale (FIG 6, closure device 600; ¶41), comprising:
a body (FIG 6, flexible closure line 625) having a proximal end and a distal end (¶42);
a disk (621) coupled near the proximal end of the body (¶42), the disk configured to seal the patent foramen ovale in the right atrium (FIG 6); and
an expandable anchor (620) coupled near the proximal end of the body (FIG 6; ¶42) configured to engage the septum proximate patent foramen ovale (PFO) in the left atrium (¶42).
Olsen does not teach the anchor comprising asymmetrical expandable petal anchors having multiple petal groups with asymmetrical petals of two or more sizes having a rearward curvature configured to engage the septum proximate patent foramen ovale in the left atrium.
Werneth teaches an implant (FIGs 16A-C, implant 270, ¶93) for sealing a patent foramen ovale (¶68) and a body having a proximal end (278, ¶93) and a distal end (280, ¶93). Werneth teaches the anchor (FIGs 16A-C, anchor 276) comprising asymmetrical (leaflets 272, 274, 276) expandable (¶88) petal anchors (leaflets 272, 274, 276, ¶93) having multiple petal groups (leaflets 272, 274, 276) with asymmetrical petals of two or more sizes (FIGs 16A-C, larger blades 272, smaller blades 274, more narrow blades 276) having a rearward curvature (FIG 16B) configured to engage the septum proximate patent foramen ovale in the left atrium (¶¶68, 93).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Olsen and Werneth, given that the prior art included each element claimed, although not necessarily in a single reference. Olsen and Werneth teach in the same field of endeavor, occlusion devices for undesirable orifices in the heart, including patent foramen ovale.
Although, Olsen discloses the claimed base implant (body, disk, flexible anchor comprising two expandable anchors), Olsen does not disclose the anchor comprising asymmetrical expandable petal anchors having multiple petal groups with asymmetrical petals of two or more sizes having a rearward curvature configured to engage the septum proximate patent foramen ovale in the left atrium.
Werneth specifically addresses the structure of the anchor (FIGs 16A-C, anchor 276) comprising asymmetrical (leaflets 272, 274, 276) expandable (¶88) petal anchors (leaflets 272, 274, 276, ¶93) having multiple petal groups (leaflets 272, 274, 276) with asymmetrical petals of two or more sizes (FIGs 16A-C, larger blades 272, smaller blades 274, more narrow blades 276) having a rearward curvature (FIG 16B) where the anchor is configured to engage the septum proximate patent foramen ovale in the left atrium (¶¶68, 93). Because Olsen’s base implant comprises expandable anchors and body, a person of ordinary skill in the art, seeking to better control the closure of the patent foramen ovale in Olsen’s architecture would reasonably consult Werneth’s multiple anchor solution. Werneth’s multianchor solution can be incorporated alongside or substituted for Olsen’s base flexible anchor solution (same general location, same purpose) using known assembly methods without redesigning Olsen’s core occlusion device.
Because the references address the same engineering problem (closing a septal defect in a heart using a comprising a body, a disk, and an anchor system configured to engage the septum proximate patent foramen ovale in the left atrium) and the proposed modifications involving different and improved anchoring mechanisms are mechanically compatible and implemented by routine engineering practices (adding a multi-leaf anchor adjacent to (combinatorial) or in place of (substitution) the existing anchor), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Werneth teaches wherein the asymmetrical petals are configured to accommodate the anatomy of the septum wall (FIGs 16A-C; ¶¶68, 93).
Regarding currently amended claim 3, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Werneth teaches wherein the asymmetrical petals are self-expanding (¶88).
Regarding claim 4, Olsen modified by Werneth teaches the implant of claim 3, as set forth above, for the reasons set forth above.
Werneth teaches wherein the asymmetrical petals are made from a shape memory material (nitinol, ¶88) that is pre-shaped in a desired rearward curvature shape (FIG 16B, ¶93).
Regarding claim 5. Olsen modified by Werneth teaches the implant of claim 3, as set forth above, for the reasons set forth above.
Werneth teaches wherein the asymmetrical petals are configured to be collapsed or compressed to a delivery shape for delivery and self-expand to the desired curvature shape at the delivery site (¶88).
Regarding currently amended claim 6, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Werneth teaches wherein the multiple petal groups are on opposite sides of the body (FIGs 16A-C).
Regarding currently amended claim 7, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Werneth teaches wherein the groups of asymmetrical pedals include two or more petals per group (FIGs 16A-C, ¶93).
Regarding currently amended claim 8, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Werneth teaches wherein the asymmetrical petals are adjustable in size (¶¶92, 93)
The phrase “adjustable in size” is read in its broadest reasonable interpretation in light of the specification. At ¶39, the specification discloses “[t]he adjustable petal wires for each petal allows adjustability of the petals to accommodate the anatomy or placement requirements of the implant. For example, the size of the petal may be changed to engage or avoid heart structures or defects in the septum wall.” Accordingly, the teachings at Werneth at ¶92 comport with the adjustability defined in the specification as being sized to accommodate anatomy.
Regarding currently amended claim 9, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Embodiment 270 (FIGs 16A-C) of Werneth does not expressly teach wherein the asymmetrical petals are adjustable either individually or in groups.
However, in embodiment 290 (FIGS 17A-B), Werneth teaches “by staggering the attachment points of the blades and hubs, the angle at which the blade extends from the hub can also be varied (¶94). Embodiment 310 (FIG 18; ¶95) of Werneth teaches that the leaflets can be overlapped in an appropriate pattern to create a varying structural stiffness or to create a more dense blood barrier” (¶95).
Werneth also uses several synonyms for “adjustability” including adapted, staggering, and varying (¶¶90, 91, and 94-98).
The phrase “adjustable” in claim 9 is read in its broadest reasonable interpretation in light of the specification. At ¶38, the specification discloses “[h]aving adjustable petal wires for each petal segment allows individual adjustability of the petal groups to accommodate the anatomy or placement requirements of the implant. For example, the implant may be torqued or rotated so the petals of the petal groups lie relatively flat around patent foramen ovale 60 or atrial septal defect 70 and avoid defects or structures around the patent foramen ovale 60 or atrial septal defect 70.” Accordingly, the teachings at Werneth at ¶93 comport with the adjustability defined in the specification to accommodate anatomy.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Olsen and the multiple embodiments taught in Werneth, given that the prior art included each element claimed, although not necessarily in a single reference. Olsen and Werneth teach in the same field of endeavor, occlusion devices for undesirable orifices in the heart, including patent foramen ovale.
Although, Olsen discloses the claimed base implant (body, disk, flexible anchor comprising two expandable anchors), Olsen does not disclose the anchor comprising asymmetrical expandable petal anchors having multiple petal groups with asymmetrical petals of two or more sizes having a rearward curvature configured to engage the septum proximate patent foramen ovale in the left atrium.
Werneth specifically addresses the structure of the anchor (FIGs 16A-C, anchor 276) comprising asymmetrical (leaflets 272, 274, 276) expandable (¶88) petal anchors (leaflets 272, 274, 276, ¶93) having multiple petal groups (leaflets 272, 274, 276) with asymmetrical petals of two or more sizes (FIGs 16A-C, larger blades 272, smaller blades 274, more narrow blades 276) having a rearward curvature (FIG 16B) where the anchor is configured to engage the septum proximate patent foramen ovale in the left atrium (¶¶68, 93), as set forth above in claim 1.
Werneth also specifically addresses the adjustment of the leaflets (petals) including adaptations, staggering, and varying them to conform with anatomy or specific use cases, either individually or in groups, in the different embodiments of at least implants 290 and 310. Because Werneth’s base implant is made from shape memory materials, such as nitinol (¶88), comprises expandable (¶88) anchors, a body, asymmetric adjustable pedals, including two or more petals per group (FIGs 16A-C, ¶93) and wherein the asymmetrical petals are adjustable in size (¶¶92, 93), a person of ordinary skill in the art, seeking to better control how the implant fits into the defect of the patent foramen ovale would reasonably consult Werneth’s multiple embodiments which teach adjustability in terms of adaptations, staggering the leaflets, and varying the blades and hubs at different angles and in different patterns to create different structural stiffness according to anatomical requirements. Werneth’s adjustable variations of leaflets (petals) on an individual or group basis solution(s) can be incorporated alongside or substituted for Olsen’s based flexible implant and/or Werneth’s base implant embodiment 270 as flexible anchor solutions (same general location, same purpose) permitting a wide range of adaptability and variations on an individual leaflet (petal) or group basis, using known assembly methods without redesigning Olsen’s or Werneth’s core occlusion device.
Because the references address the same engineering problem (closing a septal defect in a heart using a comprising a body, a disk, and an anchor system configured to engage the septum proximate patent foramen ovale in the left atrium) and the proposed modifications involving different, improved, and individually adjustable anchoring mechanisms are mechanically compatible and implemented by routine engineering practices (adding a multi-leaf anchor adjacent to (combinatorial) or in place of (substitution) the existing anchor), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 10, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, as set forth above, for the reasons set forth above.
Olsen teaches wherein the disk is self-expanding (¶65).
Regarding claim 11, Olsen modified by Werneth teaches the implant of claim 10, as set forth above, for the reasons set forth above.
Olsen teaches wherein the expandable disk is a mesh structure made from a shape memory material that is pre-shaped in a desired disk shape (FIG 6; ¶57, nitinol).
Regarding claim 12, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Olsen teaches wherein the disk is covered with a covering material (FIGs 11-13, positional retention mechanism 627).
Regarding claim 13, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Olsen teaches wherein the expandable disk is configured to be collapsed or compressed to a delivery shape for delivery and self-expand to the desired disk shape at the delivery site (FIGs 6; ¶¶41, 42).
Regarding claim 14, Olsen modified by Werneth teaches the implant of claim 1, as set forth above, for the reasons set forth above.
Werneth teaches wherein the proximal end of the body includes a coupler configured to releasably couple with a distal shaft of a delivery catheter (¶128, delivery element 602 is adapted to be releasably coupled to a delivery tool (not shown)).
Regarding claim 15, Olsen modified by Werneth teaches the implant of claim 14, as set forth above, for the reasons set forth above.
Olsen teaches wherein the coupler includes one or more slots and the distal shaft end of the shaft include or more engagement arms, the one or more engagement arms being configured to couple with one or more slots to allow the distal shaft of the delivery system to rotate or torque the implant during delivery (FIGs 7A, 7B; ¶45 locking mechanism 627, mechanical appendage or tang 628; ¶44-46).
Conclusion
Claims 1-15 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-6pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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