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 .
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 prosthetic valve comprising an outer frame having a tubular medial portion having a straight wall frame segment with an irregular cross-sectional shape and an outflow end portion that tapers radially inward (claim 1), the prosthetic valve comprising an outer frame having a medial portion having a straight wall frame segment and an outflow end portion that tapers radially inward (claim 5), the prosthetic valve comprising one or more leaflets secured to/associated with the leaflet support structure, wherein the leaflet support structure comprises a laminate formed of a plurality of layers of polymer (claims 6 and 20), and the prosthetic valve comprising an outer frame, wherein a form of the outer frame varies around a circumference of the outer frame (claim 8) 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claims 6 and 20 set forth the parameter of “the leaflet support structure comprises a laminate formed of a plurality of layers of polymer”, however this parameter was never detailed, explained, or even mentioned in the originally filed specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6, 8 and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, which, on lines 5-6, sets forth the parameter of the tubular medial portion, of the outer frame, has “an irregular cross-sectional shape that conforms to a mitral valve annulus”; however this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “irregular”; specifically, irregular in what way and/or compared to what. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 6 and 20, which set forth the parameter of “the leaflet support structure comprises a laminate formed of a plurality of layers of polymer”; however this parameter is found to be confusing since it is not clear how exactly a/the leaflet support structure is formed/comprises a laminate of polymer layers, and the originally filed specification does not aid in clarifying and/or explaining such a parameter, in fact the originally filed specification is completely silent regarding such a parameter. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 8, which set forth the parameter of “a form of the outer frame varies around a circumference of the outer frame”; however this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “form”. Specifically, does form mean the shape, or is it the height, or is it the thickness/width, or is it the material it is made of, or is it something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 18, which sets forth the parameter of the structure of the anterior portion differs from the structure of the posterior portion “in that a length of the anchor frame in the anterior portion is shorter than a length of the anchor frame in the anterior portion” (emphasis added); however, this parameter is found to be confusing since it is not clear how an anterior portion can have two different lengths, and/or how does the anterior portion actually, structurally, differ from the posterior portion. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can best be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “a length of the anchor frame in the anterior portion is shorter than a length of the anchor frame in the posterior portion”.
Regarding claim 19, which sets forth the parameter of the structure of the anterior portion differs from the structure of the posterior portion “in that the anchor frame is stiffer in the anterior portion than in the anterior portion” (emphasis added); however, this parameter is found to be confusing since it is not clear how an anterior portion can have two different stiffnesses, and/or how does the anterior portion actually, structurally, differ from the posterior portion. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can best be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “the anchor frame is stiffer in the anterior portion than in the posterior portion”.
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 § 102
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.
Claims 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morris et al. (US PG Pub. 2015/0142100), as disclosed in the IDS dated , hereinafter Morris.
Regarding claim 15, Morris discloses a prosthetic valve (100), illustrated in Figures 16A-16D, comprising an anchor frame (110/210) defining an anchor frame lumen, the anchor frame (210) having an annular form including an anterior portion (255) having a first structural form and a posterior portion (256) circumferentially offset from the anterior portion and having a second structural form; a leaflet support structure (120); one or more leaflets (130) associated with the leaflet support structure; and a retention structure (310) configured to hold the leaflet support structure (120) in a fixed position relative to the anchor frame (110) when the leaflet support structure is disposed at least partially within the anchor frame lumen in a deployed configuration of the prosthetic valve, illustrated in Figures 16A-16D, 22A and 22B ([0140]; [0170]; [0193]; [0203]; [0204], Lines 1-4; [0208] & [0224]).
Regarding claim 16, Morris discloses the prosthetic valve of claim 15, further comprising one or more rows of protruding barbs projecting radially outward from the anchor frame ([0170] & [0172]).
Regarding claim 17, Morris discloses the prosthetic valve of claim 15, wherein an axis of the leaflet support structure (120) has a tilt angle between 15–45° relative to an axis of the anchor frame (210), illustrated in Figure 16D ([0211]).
Regarding claim 18, Morris discloses the prosthetic valve of claim 15, wherein the first structural form of the anterior portion (255) of the anchor frame differs from the second structural form of the posterior portion of the anchor frame in that a length (E2) of the anchor frame in the anterior portion (255) is shorter than a length (E3) of the anchor frame in the posterior portion (256),illustrated in Figures 17A-17C ([0140] & [0208]).
Regarding claim 19, Morris discloses the prosthetic valve of claim 15, wherein the first structural form of the anterior portion of the anchor frame differs from the second structural form of the posterior portion of the anchor frame in that the anchor frame is stiffer in the anterior portion than in the posterior portion ([0193]).
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 1-5, 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Oba et al. (US PG Pub. 2016/0310268), hereinafter Oba.
Regarding claims 1-4, Oba discloses a prosthetic valve (300), illustrated in Figures 7-13, comprising an outer frame (302/308) configured to assume an expanded configuration in which the outer frame defines an outer frame lumen and includes: an inflow flange (314) that flares radially outward, a cover (310) that at least partially covers the inflow flange (314) and provides a tissue abutment surface for the outer frame; a tubular medial portion (312) having a straight wall frame segment that conforms to a mitral valve annulus shape and one or more rows of barbs (318/320) protruding radially outward from the outer frame (308) and angled towards an inflow end of the prosthetic valve (300); and an outflow end portion that tapers radially inward; an inner frame (304/322) having a circular cross-sectional shape; one or more leaflets (326/328) secured within the inner frame (322); and a membrane (306), comprising fabric, configured to hold the inner frame in a floating position spaced from, and at least partially within, the outer frame lumen in a deployed configuration of the prosthetic valve, illustrated in Figures 7-13 ([0053]; [0100]; [0101]; [0103];[0105] – [0107]; [0116] & [0135] - it is to be noted that though the embodiment of Figures 7-13 does not specifically disclose the outflow end portion, of the outer frame, tapering radially inward, the embodiment of Figures 26-30 does disclose such a shape/form; and it is stated that the disclosure covers embodiments with various combinations of embodiments); and though it is not specifically disclosed that the tubular medial portion, of the outer frame, has an irregular cross-sectional shape, it is disclosed that a mitral valve/annulus can have “D-shaped, oval, or otherwise out-of-round cross-sectional shape” ([0004], 6th – 4th to Last Lines). Thus, it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the tubular medial portion, of the outer frame, including having an irregular cross-sectional shape, in order to conform to/meet the irregular shape of a mitral valve; and since doing so merely amounts to a change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claims 5 and 7, Oba discloses a prosthetic valve (800), illustrated in Figures 36 and 37, comprising an outer frame (802/502) defining an outer frame lumen, the outer frame including: an inflow flange (518) that flares radially outward; a medial portion (516) having a straight wall frame segment; and an outflow end portion that tapers radially inward, illustrated in Figures 26-30 ([0132]; [0133]; [0135] & [0157], Lines 1-5); a leaflet support structure (804); one or more leaflets secured to the leaflet support structure (804); and a retention structure (806) configured to hold the leaflet support structure (804) in a fixed position relative to the outer frame (802) when the leaflet support structure is disposed at least partially within the outer frame lumen in a deployed configuration of the prosthetic valve, wherein in the deployed configuration, the leaflet support structure (804) extends distally beyond the outflow end portion of the outer frame (802), illustrated in Figures 36 and 37 ([0156]; [0161] & [0164]).
Regarding claim 8, Oba discloses the prosthetic valve of claim 5, and though it is not specifically disclosed a form of the outer frame varies around a circumference of the outer frame, it is disclosed that a mitral valve/annulus can have “D-shaped, oval, or otherwise out-of-round cross-sectional shape” ([0004], 6th – 4th to Last Lines). Thus, it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the outer frame, of the prosthetic valve of Oba, including having a circumference that varies, in order to conform to/meet the irregular shape of a mitral valve; and since doing so merely amounts to a change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claims 10-12, Oba discloses the prosthetic valve of claim 5, further comprising a connecting sheath (306) that is coupled between the outflow end portion of the outer frame (302) and an inflow end portion of the leaflet support structure (304), wherein, in the deployed configuration of the prosthetic valve the connecting sheath (306) is disposed at least partially radially between the leaflet support structure (304) and the outer frame (302); and the connecting sheath (306) is tapered radially inward moving in a direction from the outflow end portion of the outer frame to the inflow end portion of the leaflet support structure, wherein the connecting sheath (306) has a flow aperture (307) formed therein and a flap (309) associated with the connecting sheath that is configured to cover the flow aperture, illustrated in Figures 7-11 ([0053] & [0116] – [0118] – it is to be noted that though the connecting sheath is shown in a different embodiment than that of Figures 36 and 37, it is stated that the disclosure is directed toward/covers all features and aspects of various embodiments in various combinations with one another; thereby including the combination of the connecting sheath 306 with the embodiment of the prosthetic valve of Figures 36 and 37).
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 1,4-7, 9-11, 13-15, 18 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 14, 19, 20 and 26 of U.S. Patent No. 11,497,601. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a prosthetic heart valve comprising an outer/anchor frame configured to expanded, defining a lumen and includes an inflow flange/flare that flares radially outward and an outflow end portion; an inner frame/leaflet support having leaflets secured therein; a membrane configured to hold the inner frame in a floating position spaced from, and at least partially within, the outer frame lumen in a deployed configuration of the prosthetic valve, and/or a retention structure configured to hold the leaflet support structure in a fixed position relative to the outer frame when the leaflet support structure is disposed at least partially within the outer frame lumen in a deployed configuration of the prosthetic valve, wherein the connecting sheath that is coupled between the outflow end portion of the outer frame and an inflow end portion of the leaflet support structure, wherein, in the deployed configuration of the prosthetic valve, the retention structure spans between the inflow end portion of the leaflet support structure and an end portion of the inflow flange of the outer frame, and/or a length of the anchor frame in the anterior portion is shorter than a length of the anchor frame in the anterior portion, and/or the anchor frame is stiffer in the anterior portion than in the anterior portion.
Allowable Subject Matter
Claims 9, 13 and 14 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims, and overcome the Double Patenting rejection, set forth in this Office Action.
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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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.
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/DINAH BARIA/Primary Examiner, Art Unit 3774
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