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 .
Status of Claims
This office action is responsive to the amendment filed on 05/21/2024. As directed by the amendment: claims 41 and 43 have been amended, claims 1-36, 39, 40, 42, 46-51, 59, 64, 65, 67 and 70-74 have been cancelled and no new claims have been added. Thus, claims 37, 38, 41, 43-45, 52-58, 60-63, 66, 68 and 69 are presently pending in this application, and currently examined in the Office Action.
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 37, 38, 41, 43-45, 52-58, 60-63, 66, 68 and 69 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 claims 37, 41 and 43, which recite the limitation “the native leaflet restraint”, on line 7 of claim 37 and line 2 of claims 41 and 43; there is insufficient antecedent basis for this limitation in the claims. In order to overcome this rejection, and keep claim terminology consistent, it is suggested the word “native” be deleted from the above mentioned limitation in all the claims.
Regarding claim 38, which sets forth the parameter of anchoring the ventricular anchor “at an anchoring site within the ventricle that sets a desired angle of a best-fit plane defined by the net with respect to a plane of the annulus, in order to set a level of restraint of the single native cardiac leaflet”; however, this parameter is found to be confusing since it is not clear what exactly is meant by the terms “a desired angle” and “a best-fit plane. Specifically, what exactly angle, quantitatively, would be need in order to meet the limitation of “a desired angle” and what/where is a best-fit plane located/in relation to. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 53 and 54, which set forth the parameter of “the net defines a plurality of openings having an average opening area…” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally/dimension-wise, is meant by the term “opening area”. Specifically, is the opening area the pore size/diameter or is it a specific area of the net which includes the plurality of openings, or is it something else completely different. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 55-57, which set forth the parameter(s) of the net defines a plurality of openings, and wherein two/three/five or more “of the openings have respective opening areas different from one another, when the net is in a fully-expanded planar configuration”; however these parameters are found to be confusing for a couple of reasons. Firstly, as mentioned above, it is unclear what exactly, structurally/dimension-wise, is meant by the term “opening areas”, and secondly, it is unclear if the two/three/five or more “openings” are single pores/cells, or if they are different sections of the net that have a plurality of pores/cells. Specifically, are the two/three/five or more openings, two/three/five or more sections of the net which each have a plurality of openings/pores and the openings/pores in each section are different from one another, or are they two/three/five or more single openings/pores/cells, which are different from one another, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 58, which sets forth the parameter of “the opening area of a first one of the two or more of the openings equals at least 110% of the opening area of a second one”; however these parameters are found to be confusing for a couple of reasons. Firstly (as mentioned above regarding claims 53 and 54), it is unclear what exactly, structurally/dimension-wise, is meant by the term “opening area”, and secondly, it is unclear what and/or how exactly an opening can have “at least 110% of the opening area” of another opening. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 60-62, which set forth the parameters of the opening areas of the plurality of openings vary/decrease/increase along the net between the annular side and the ventricular end of the net; however, these parameters are found to be confusing for a couple of reasons. Firstly, as previously mentioned, it is unclear what exactly, structurally/dimension-wise, is meant by the term “opening areas; specifically, is the opening area the pore size/diameter or is it a specific area of the net which includes the plurality of openings, or is it something else completely different. Secondly, it is unclear how exactly the opening areas vary, decrease, and/or increase; specifically, do the open areas vary/decrease/increase in size, shape, or in some other way. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 66, which sets forth the parameter of “an average of the opening areas of the plurality of openings on an annular half of the net is different from an average of the opening areas of the plurality of openings on a ventricular half of the net”; however, this parameter is found to be confusing for multiple reasons. Firstly, as previously mentioned, it is unclear what exactly, structurally/dimension-wise, is meant by the term “opening area”; secondly, it is unclear what exactly is meant by an average of the opening areas, does this mean and average opening/pore size, or an average location of the plurality of opening, or some other completely different average; and finally, it is unclear what exactly is different, the size, shape, location etc. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
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 37, 38, 41, 43, 44, 66 and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Speziali et al. (US PG Pub. 2018/0289483), as disclosed in the IDS dated 12/15/2025, hereinafter Speziali.
Regarding claim 37, Speziali discloses a method for treating a single native cardiac leaflet of a native atrioventricular valve of a heart comprising anchoring two tissue-penetrating annulus anchors (204) of a leaflet restraint (200) to an annulus of the native atrioventricular valve along a portion of the annulus to which the single native cardiac leaflet attaches; at least partially covering an atrial surface of the single native cardiac leaflet with a non-blood-occlusive net (202) of the leaflet restraint (200), wherein the tissue-penetrating annulus anchors (204) are fixed to an annular side of the net (200); and anchoring a ventricular anchor (206) of the leaflet restraint to a ventricle of the heart so as to anchor a ventricular end of the net (202) to the ventricle, such that the leaflet restraint (200) limits prolapse of the single native cardiac leaflet into an atrium of the heart, wherein the method does not comprise anchoring any annulus anchors to the annulus other than along the portion of the annulus to which the single native cardiac leaflet attaches, illustrated in Figure 6 ([0007]; [0032]; [0036]; [0039]; [0040] & [0054], Lines 1-7).
Regarding claim 38, Speziali discloses the method according to claim 37, wherein anchoring the ventricular anchor (206) comprises anchoring the ventricular anchor at an anchoring site (14) within the ventricle that sets a desired angle of a best-fit plane defined by the net (202) with respect to a plane of the annulus (210), in order to set a level of restraint of the single native cardiac leaflet, illustrated in Figure 6 ([0036]; [0039]; [0040] & [0054], Lines 1-7).
Regarding claim 41, Speziali discloses the method according to claim 37, wherein the leaflet restraint (200) further includes an annular support (114) that extends along at least a portion of the annular side of the net (202), in order to maintain a length of the annular side of the net, and wherein the annular support (114) is defined by a discrete element fixed to the at least a portion of the net (202), illustrated in Figures 4A and 6 ([0034]; [0036], Lines 15-16; [0039] & [0054], Lines 1-7).
Regarding claims 43 and 44, Speziali discloses the method according to claim 37, wherein the leaflet restraint (200) further includes an annular support (114) that extends along at least a portion of the annular side of the net (202), in order to maintain a length of the annular side of the net, wherein the net comprises a plurality of flexible elongate members/suture material, wherein the annular support (114) is defined by the at least a portion of the annular side of the net, and wherein the flexible elongate members/suture material of the at least a portion of the annular side of the net are woven/braided so to provide the annular support with greater rigidity than other portions of the net, illustrated in Figures 4A and 6 ([0034]; [0035], Lines 4-9; [0036], Lines 15-16; [0039] & [0054], Lines 1-7).
Regarding claim 66, Speziali discloses the method according to claim 37, wherein the net comprises a plurality of flexible elongate members arranged so as to define a plurality of openings/having a porosity, and wherein the net, when in a fully-expanded planar configuration, has a material surface area ratio of 5% - 80%, the material surface area ratio defined as the ratio of material of the flexible elongate members to an area of the net, including the plurality of openings and the material of the flexible elongate members ([0041]).
Regarding claim 68, Speziali discloses the method according to claim 37, wherein the net (202), when in a fully- expanded planar configuration, includes a triangular portion, illustrated in Figure 6 (to clarify, any random triangular portion could be arranged to fit within net 202).
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 45, 52-58, 60-63 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Speziali.
Regarding claim 45, Speziali discloses the method according to claim 43, and though it is not specifically disclosed the flexible elongate members/suture material of the at least a portion of the annular side of the net are rolled in a scroll-shaped arrangement, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. 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 way to form the annular support (114), including having it be formed by rolled in a scroll-shaped arrangement, as opposed to being woven/braided, since these are art equivalent means for forming an annular support which has greater rigidity than other portions of the net. Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of annular support being formed by rolling in a scroll-shaped arrangement, as opposed to any other way/method.
Regarding claim 52, Speziali discloses the method according to claim 37, wherein the net (202) defines a plurality of openings ([0041]), but does not specifically disclose the net, when in a fully-expanded planar configuration, has an area, including the plurality of openings, of at least 100mm2; however, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. 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 size, for the net in a fully-expanded planar configuration, including a size which results in a surface area, including the plurality of openings, of at least 100mm2, based on intended use and/or patient specificity; and such a modification would have involved a mere change in the size of a component/the net, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of net, in a fully-expanded planar configuration, having an area, including the plurality of openings, of at least 100mm2, as opposed to any other size/area.
Regarding claims 53 and 54, Speziali discloses the method according to claim 37, wherein the net defines a plurality of openings ([0041]), but does not specifically disclose the openings having an average opening area of at least 10 mm2, when the net is in a fully-expanded planar configuration; however, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. 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 average size, for the opening area, when the net is in a fully-expanded planar configuration, including at least 10 mm2, since such a modification would have involved a mere change in the size of a component/opening area, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the average opening area being at least 4mm2 and further at least 10mm2, when the net is in a fully-expanded planar configuration, as opposed to any other size/area.
Regarding claims 55-57, Speziali discloses the method according to claim 37, wherein the net defines a plurality of openings ([0041]), but does not specifically disclose two, three, five or more of the openings have respective opening areas different from one another, when the net is in a fully-expanded planar configuration; however, these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. 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 appropriate sizes/areas, for the openings, when the net is in a fully-expanded planar configuration, including two, three, five or more of the openings having different sizes/areas from one another, since such a modification would have involved a mere change in the size/area of a component/opening, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of two, three, five or more of the openings have respective opening areas different from one another, when the net is in a fully-expanded planar configuration, as opposed to any other distribution/size/area.
Regarding claim 58, Speziali discloses the method according to claim 55, and though it is not specifically disclosed that the opening area of a first one of the two or more of the openings equals at least 110% of the opening area of a second one of the two or more of the openings, when the net is in the fully-expanded planar configuration; this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. 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 appropriate sizes/areas, for the openings, when the net is in a fully-expanded planar configuration, including a first one having at least 110% of the opening area of a second one, since such a modification would have involved a mere change in the size/area of a component/opening, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of a first one of the two or more of the openings equals at least 110% of the opening area of a second one of the two or more of the openings, when the net is in the fully-expanded planar configuration, as opposed to having any other distribution/size/area.
Regarding claims 60-63, Speziali discloses the method according to claim 55, and though it is not specifically disclosed that the opening areas of the plurality of openings vary, i.e. decrease or increase, along the net between the annular side and the ventricular end of the net, such that the average of the opening areas of the plurality of openings on an annular half of the net are different from an average of the opening areas of the plurality of openings on a ventricular half of the net; these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. 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 appropriate sizes/areas and/or distributions, for the plurality of openings, including the sizes/areas vary, i.e. decrease or increase, along the net between the annular side and the ventricular end of the net, such that the average of the opening areas of the plurality of openings on an annular half of the net are different from an average of the opening areas of the plurality of openings on a ventricular half of the net, since such a modification would have involved a mere change in the size/area of a component/openings, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the opening areas of the plurality of openings vary, i.e. decrease or increase, along the net between the annular side and the ventricular end of the net, such that the average of the opening areas of the plurality of openings on an annular half of the net are different from an average of the opening areas of the plurality of openings on a ventricular half of the net, as opposed to having any other distribution/size/area.
Regarding claim 69, Speziali discloses the method according to claim 37, and though it is not specifically disclosed that the net, in a fully-expanded planar configuration, is triangular, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; and it is noted that Speziali states that other shapes, besides what is disclosed could be used ([0009], Last 4 Lines & [0054], Last 4 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 for the net, in a fully-expanded planar configuration, including being triangular, since such a modification would have involved a mere 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).
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/07/2026