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
Newly submitted claims 21-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9, drawn to a prosthetic heart valve, classified in A61F 2/2418.
II. Claims 21-30, drawn to a method of capturing a leaflet and deploying an implant between the ascending aorta and a left ventricle of the heart, classified in A61B2017/00243.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different method such as being deployed the GI tract (i.e. as a pyloric valve) or other body locations requiring a one-way valve.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired separate status in the art in view of their different classification which in turn requires a different field of search for example searching different classes/subclasses and electronic resources or employing different search queries. Additionally the prior art applicable to one invention would not likely be applicable to another invention.
Since applicant has received detailed restriction requirement for originally presented invention and affirmatively elected to pursue Invention I, claims 1-9 drawn to a prosthetic heart valve in the response filed on February 11, 2026, this newly submitted invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 1-4 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al (US Pat. No. 9,532,870).
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Regarding claim 1, Cooper teaches a prosthetic heart valve comprising:
an annular frame that is expandable from a crimped state (Fig. 9) to a deployed state (Fig. 8); a first valvular structure formed by a leaflet assembly (See Col. 6, lines 22-24; Col. 9, lines 63-68), the leaflet assembly comprising a plurality of leaflets, the first valvular structure being disposed within and attached to the annular frame (See Figs. 2, 13, and 14; and Col. 6, lines 22-24; Col. 9, lines 63-68); and
a leaflet capture member (220 & 216) disposed along an exterior of the annular frame and coupled at opposite ends thereof to the annular frame, the leaflet capture member extending along an axial direction of the annular frame, the leaflet capture member comprising a distal portion (generally near 216), a proximal portion (generally near 214/220), and an intermediate portion between (entirety of connected portions therebetween) and coupled to the distal and proximal portions by respective connecting portions (See Fig. 9),
wherein the leaflet capture member is configured to change shape upon expansion of
the annular frame to the deployed state (note the change in shape from Fig 9 to Fig. 9A; See also Col. 13, line 62 through Col. 15, line 49) so as to capture a free end of a leaflet of an existing second valvular structure (native leaflets) between the intermediate portion and the distal portion (See Fig. 9A; Col 7, lines 22-46; Col. 15, lines 34-37).
Regarding claim 2, Cooper teaches the prosthetic valve required by claim 1 as set forth above and further teaches additional leaflet capture members disposed at different locations along a circumference of the annular frame. (See Figs. 7-10; Col. 13, line 63 through Col. 14, line 15).
Regarding claim 3, Cooper teaches the prosthetic valve required by claim 1 as set forth above and further teaches wherein each leaflet capture member comprises a substantially1 straight bar extending along the axial direction prior to expansion of the annular frame. (See Fig. 9, note the bars are substantially straight, aka, are not curved, in the axial direction)
Regarding claim 4, Cooper teaches the prosthetic valve required by claim 1 as set forth above and further teaches wherein at least the proximal portion of each leaflet capture member has an open cell structure (open loop near 214; See Figure 9) that allows blood to flow therethrough. (not there is no structure which would prevent blood from flowing through the open loop at the end of tine 220)
Regarding claim 8, Cooper teaches the prosthetic valve required by claim 1 as set forth above and further teaches the leaflet capture member is formed of metal (See Col. 9, lines 28-34).
Regarding claim 9, Cooper teaches the prosthetic valve required by claim 1 as set forth above and further teaches prior to expansion of the annular frame, a first connecting portion that couples the proximal portion to the intermediate portion is disposed proximal to a second connecting portion that couples the distal portion to the intermediate portion; and after expansion of the annular frame, the first connecting portion is disposed distal to the second connecting portion. (See annotated Fig. 9 above; note that “1st and 2nd connecting portions” are very broad terms. Since the anchor segments are all directly connected to each other, the arrangement as marked above is sufficient to meet the limitation as presently claimed).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al (US Pat. No. 9,532,870) in view of Orth et al (US Pat. No. 5,591,197).
Regarding claim 5, Cooper teaches the prosthetic valve required by claim 1 as set forth above but does not explicitly teach wherein at least one of the connecting portions comprises a weakened region. Cooper teaches the prosthetic valve frame and anchors may be made of shape memory material to allow for the desired deformation of the anchoring elements (See Col. 10, lines 39-54).
Orth teaches an analogous implantable medical device which uses weakened portions (21) in the connector members in order to have the connectors deform in the desired manner (See Col. 4, lines 32-44; Col. 6, lines 45-68) when the device is deployed.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the prosthetic valve as taught by Cooper to incorporate the weakened areas as taught by Orth to facilitate the desired bending/folding of the device when deployed. Additionally, doing so would merely be applying a known technique (weakened portions to facilitate bending in a specific location on a device as taught by Orth) to a known device (prosthetic valve as taught by Cooper) to yield predictable results (anchors which bend in the desired location upon deployment). (See MPEP §2143(D))
Regarding claim 6, Cooper teaches the prosthetic valve required by claim 1 as set forth above but does not explicitly teach at least one of the connecting portions comprises a region with a narrowed cross-section compared to the distal portion, the proximal portion, and/or the intermediate portion.
Cooper teaches the prosthetic valve frame and anchors may be made of shape memory material to allow for the desired deformation of the anchoring elements (See Col. 10, lines 39-54).
Orth teaches an analogous implantable medical device which uses a region with a narrowed cross section (21) in the connector members in order to have the connectors deform in the desired manner (See Col. 4, lines 32-44; Col. 6, lines 45-68) when the device is deployed. (note the notch has a smaller cross section than the rest of the strut)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the prosthetic valve as taught by Cooper to incorporate the region with a narrowed cross section as taught by Orth to facilitate the desired bending/folding of the device when deployed. Additionally, doing so would merely be applying a known technique (a region with a narrowed cross section to facilitate bending in a specific location on a device as taught by Orth) to a known device (prosthetic valve as taught by Cooper) to yield predictable results (anchors which bend in the desired location upon deployment). (See MPEP §2143(D))
Regarding claim 7, Cooper teaches the prosthetic valve required by claim 1 as set forth above but does not explicitly teach at least one of the connecting portions comprises a notched or grooved region.
Cooper teaches the prosthetic valve frame and anchors may be made of shape memory material to allow for the desired deformation of the anchoring elements (See Col. 10, lines 39-54).
Orth teaches an analogous implantable medical device which uses a notched or grooved region (21) in the connector members in order to have the connectors deform in the desired manner (See Col. 4, lines 32-44; Col. 6, lines 45-68) when the device is deployed.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the prosthetic valve as taught by Cooper to incorporate the notched or grooved region as taught by Orth to facilitate the desired bending/folding of the device when deployed. Additionally, doing so would merely be applying a known technique (a notched or grooved region to facilitate bending in a specific location on a device as taught by Orth) to a known device (prosthetic valve as taught by Cooper) to yield predictable results (anchors which bend in the desired location upon deployment). (See MPEP §2143(D))
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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 call the examiner at the number listed above. Applicant may 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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims.
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