DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
This office action is responsive to the amendment filed on 09/06/2026. As directed by the amendment: claims 3 and 8 have been amended, no additional claims have been cancelled, and no new claims have been added. Thus, claims 3-13 are presently pending in this application, and currently examined in the Office Action.
Terminal Disclaimer
The terminal disclaimer filed on 09/06/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 9,474,599, 10,321,989, 11,504,230, and 12,127,937 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the arrangement comprising a loop-shaped support having a helical shape comprising a first loop and a second loop, wherein the first loop comprises a flange unit, a radially expandable prosthetic heart valve positioned through loop-shaped support, the loop-shaped support comprising an extension pointing in a direction towards the atrium and/or the ventricle, and the extension is configured for supporting the prosthetic valve inside the loop-shaped support (claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 3-11, 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Keränen (US PG Pub. 2010/0145440), as previously presented, in view of Rowe et al. (US PG Pub. 2009/0319037), as previously presented, hereinafter Rowe.
Regarding claims 3, 6, 7 and 9, Keränen discloses an arrangement (40), for replacement or repair of a native mitral valve, comprising a loop-shaped support (41), comprises three-dimensional curves, that, after delivery to a target site at the native mitral valve, has a helical shape comprising a first loop (42), having an open arcuate shape, to be positioned on an atrial side of the native mitral valve (18) and a second loop (44) to be positioned on a ventricular side of the native mitral valve, illustrated in Figures 2-6 and 10 ([0090]; [0091]; [0095] & [0121]), wherein the first loop comprises a flange unit made (50) of a tube-shaped (52) flexible material, illustrated in Figures 4-8 ([0026] & [0109]), and a prosthetic heart valve (64), which after delivery to the target site, is positioned through loop-shaped support (41), wherein an outer surface of the prosthetic heart valve is tightly position towards the flange unit (50) so that the flange unit (50) conforms to the prosthetic heart valve, whereby the area between the prosthetic heart valve and the loop-shaped support is sealed, illustrated in Figures 14a and 14b ([0026]; [0048] & [0129]); but does not specifically disclose the prosthetic heart valve is radially expandable, comprising a stent frame that is balloon expandable to have a cylindrical expanded shape.
However, Rowe teaches an arrangement, in the same field of endeavor, comprising a support (310) and a prosthetic heart valve (340), which after delivery to a target site, is positioned through the support (310), wherein the prosthetic heart valve (340) is radially expandable comprising a stent frame that is balloon expandable to have a cylindrical expanded shape, illustrated in Figure 18 ([0090]).
In view of the teachings of Rowe, it would have been obvious to one having ordinary skill in the art at the time of the invention for the prosthetic heart valve, of the arrangement of Keränen, to be radially expandable such that it comprises a stent frame that is balloon expandable to have a cylindrical expanded shape, in order to facilitate minimally invasive implantation of the arrangement/valve, thereby reducing complications, recovery time, and infection risks.
Regarding claim 4, Keränen in view of Rowe disclose the arrangement of claim 3, wherein Keränen further teaches the arrangement is configured to pinch native heart tissue between the second loop and the prosthetic heart valve, illustrated in Figures 14a and 14b.
Regarding claim 5, Keränen in view of Rowe disclose the arrangement of claim 3, wherein Keränen further teaches the flange unit is configured to take a first shape prior to implantation and a second shape upon implantation of the arrangement (Keränen: [0034]; [0035] & [0105], Last 3 Lines).
Regarding claim 8, Keränen in view of Rowe disclose the arrangement of claim 7, wherein Keränen further teaches the open arcuate shape, of the first loop (42), is C-shaped or U-shaped, illustrated in Figure 2 and modified figure 2, below.
PNG
media_image1.png
325
430
media_image1.png
Greyscale
Regarding claims 10 and 11, Keränen in view of Rowe disclose the arrangement of claim 3, wherein Keränen further teaches the loop-shaped support comprises an extension (500) pointing in a direction towards the atrium and/or the ventricle, in use, when the loop-shaped support has been placed at the native mitral valve and configured for supporting the prosthetic valve inside the loop-shaped support, illustrated in Figure 17 (Keränen: [0140] – to clarify, the extension 500 is configured for supporting the prosthetic valve inside the loop-shaped support by ensuring the loop-shaped support is firmly and properly attached/connected to the mitral valve, thereby allowing for a stable loop-shaped support for supporting the prosthetic valve; it is also to be noted that the claim(s) do not set forth any additional structural limitations the extension must have in order to meet the claimed intended use of supporting the prosthetic valve inside the loop-shaped support, thus extension 500 of Keränen reads on the claim).
Regarding claims 12 and 13, Keränen discloses a method of repairing or replacing a native mitral valve comprising delivering a loop-shaped support (41) to a target site at the native mitral valve (18) wherein, after delivery to the target site, the loop-shaped support has a helical shape comprising a first loop (42) and a second loop (44) each positioned in substantially different diametric planes, with the first loop (42) positioned on an atrial side of the native mitral valve (18) and the second loop (44) positioned on a ventricular side of the native mitral valve, illustrated in Figures 9a-10 ([0120] – [0122]); and further comprising a prosthetic heart valve (64) through said loop-shaped support (41), pinching the native heart tissue between the second loop and the prosthetic heart valve, wherein an outer surface of the prosthetic heart valve (64) is tightly position towards a flange unit made of a tube-shaped flexible material on the first loop and the second loop so that the flange unit conforms to the prosthetic heart valve, whereby the area between the prosthetic heart valve and the loop-shaped support is sealed, illustrated in Figures 14a and 14b ([0026]; [0048] & [0129]); but does not specifically disclose prosthetic heart valve is radially expandable, and the method of advancing the radially expandable prosthetic heart valve through said loop-shaped support wherein the prosthetic heart valve has a circumference smaller than a circumference of the first and second loops during advancing and expanding the prosthetic heart valve to tightly position it within the support, but Keränen does disclose that the method of inserting/positioning the prosthetic heart valve is the same as normally used to repair a native valve ([0130]).
However, Rowe teaches a method of repairing or replacing a native mitral valve ([0092], Lines 1-3), comprising advancing a radially expandable prosthetic heart valve (480) through a loop support (441), wherein the prosthetic heart valve (480) is in a compressed state such that it has a circumference smaller than a circumference of the loop support (441) during advancing, and expanding the prosthetic heart valve (480) to tightly position it within the loop support (441), such that the native valve leaflets are pinched between the loop support and the prosthetic heart valve, illustrated in Figures 25 and 26 ([0102] & [0103]).
In view of the teachings of Rowe, it would have been obvious to one having ordinary skill in the art at the time of the invention for the method of Keränen to comprise advancing a radially expandable prosthetic heart valve through the loop-shaped support, wherein the prosthetic heart valve has a circumference smaller than a circumference of the first and second loops during advancing, and expanding the prosthetic heart valve to tightly position it within the loop-shaped support, as taught by Rowe, since this is a well-known method of inserting and positioning a prosthetic heart valve to repair/replace a native mitral valve, and having a radially expandable prosthetic heart valve facilitates minimally invasive implantation, thereby reducing complications, recovery time, and infection risks.
Response to Arguments
Applicant's arguments filed 09/06/2026 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 3 as being unpatentable over the prior art of Keränen in view of Rowe, stating that the rejection, of modifying Keränen with Rowe, does not include “other adaptations to the Keränen arrangement/device…that may be necessary to accommodate the proposed modification to the prosthetic valve used by Keränen”, besides Examiner’s stated reason “to facilitate minimally invasive implantation of the arrangement/valve, thereby reducing complications, recovery time, and infection risks” (as set forth in the rejection); further stating “No evidence or reasoning is provided in support of the expected results of the proposed modification to Keränen, namely facilitating minimally invasive implantation”. Applicant goes on to state that the “combination would not have been obvious to a person of ordinary skill in the art for the following reasons”, including: “reading Keränen would have found multiple disclosures of minimally invasive delivery of Keränen's loop-shaped support and prosthetic valve by minimally invasive means (i.e. accessing the heart valve through blood vessels). For examples, see paragraphs [0042], [0060], [0121], [0130] and [0133]”; “Keränen discloses an arrangement of a loop-shaped support 41 and a prosthetic valve 40 with specified compatibility features, namely a locking mechanism of the loop-shaped support 41 which engages with a groove of the prosthetic valve 40, as seen in annotated Fig. 14A”; and in order to replace Keränen with Rowe “substantial modifications requiring considerable research and effort would have been required…Neither Rowe nor Keränen provide any guidance for how to adapt either Keränen's support or Rowe's deliver method to function together”. Examiner respectfully disagrees with Applicant’s assertions. Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference, nor is it that the claimed invention must be expressly suggested in any one or all of the references; rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art (see MPEP 2145(III)). Furthermore, it is to be noted that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art (See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)). Therefore, even though Rowe and/or Keränen do not specify/provide guidance for how to adapt/modify the prosthetic heart of Keränen with that of Rowe; it would still be obvious, to one having ordinary skill in the art, to modify the prosthetic heart of Keränen with that of Rowe in order to facilitate minimally invasive implantation of the arrangement/valve, thereby reducing complications, recovery time, and infection risks, which is based on knowledge generally available to one of ordinary skill in the art. Moreover, MPEP 2141.03(I) states that “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton”, and that “a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”.
Additionally, regarding Applicant’s arguments that the combination would not have been obvious to a person of ordinary skill in the art because Keränen discloses minimally invasive delivery of the loop-shaped support and prosthetic valve by minimally invasive means, and disclosing specified compatibility features/locking mechanism of the loop-shaped support which engages with a groove of the prosthetic valve; Examiner again, respectfully disagrees with these assertions. Specifically, paragraphs [0042], [0060], [0121], [0130] and [0133] of Keränen, which Applicant mentioned in the response regarding minimally invasive delivery, are all in reference to the loop-shaped support device (40); none of the above mentioned paragraphs, nor any other paragraph/part of the disclosure of Keränen, ever mentions or suggests that the prosthetic/artificial valve (64) is delivered by minimally invasive delivery, or that it can be radially compressed/expanded. Moreover, the prosthetic/artificial valve (64) as illustrated in Figures 14a and 14b of Keränen is a hinge/pivoting type heart valve which is traditionally known in the art/by one having ordinary skill in the art to not be minimally invasively delivered, i.e. does not have the ability to compress and expand for delivery. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify/replace the prosthetic/artificial valve of Keränen with one as taught by Rowe, which is radially expandable such that it comprises a stent frame that is balloon expandable to have a cylindrical expanded shape, in order to facilitate minimally invasive implantation, thereby reducing complications, recovery time, and infection risks. It is to be noted that the prosthetic/artificial valve of Keränen and that of Rowe are considered are equivalent devices, which perform the same function as one another; and there is nothing mentioned, or suggested, in either Keränen or Rowe which would not allow, or teach away from, such a modification/combination. This brings us to Applicant’s other assertion that combination would not have been obvious to a person of ordinary skill in the art due to Keränen disclosing compatibility features/locking mechanism of the loop-shaped support which engages with a groove of the prosthetic valve, as shown in annotated Figure 14a of the response. This assertion seems to be mere speculation by Applicant, and not based on facts as disclosed and/or illustrated by Keränen. Specifically, the entire disclosure of Keränen (including both the specification and figures) is completely silent regarding how the loop-shaped support device (40) and the prosthetic/artificial valve (64) are connected/associated with one another; furthermore, never once is there any mentioning of, and/or any illustration of, a compatibility feature and/or a locking mechanism in the disclosure of Keränen. Applicant’s annotated Figure 14a merely alleges that a portion of the flange unit (50) is “a locking element”, however there is nothing in the entire disclosure of Keränen to support such an allegation. Thus, for the reasons discussed above, the rejection of independent claim 3 as being unpatentable over the prior art of Keränen in view of Rowe is deemed to be proper, since all the structural limitations set forth in the claim are taught; hence, the rejection stands.
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 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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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, Jerrah Edwards can be reached at 408-918-7557. 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.
/DINAH BARIA/Primary Examiner, Art Unit 3774
