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
Applicant’s election without traverse of invention II (claims 54-60), species 12 (figures 73a-c), and species 2 (the clip is uncoupled to the coaptation assistance element) in the reply filed on 08/10/26 is acknowledged.
Election was made without traverse in the reply filed on 08/10/26.
Claim 60 is withdrawn as being drawn to non-elected species 1 of the clip embodiment. The Examiner points out that the claim is drawn towards a “coaptation assistance element” and thus the clip being a part of the element appears to be drawn towards the non-elected embodiment of the clip being coupled to the assistance element.
Claim Objections
Claims 54, 59, 62, 64 are objected to because of the following informalities:
Claim 54 is objected to for having improper antecedent basis for “the plane”.
Claim 59 is objected to for referring to “the anterior leaflet” with improper basis.
Further, the claim is unclear since it isn’t understood whether or not the anterior leaflet” is a part of the claimed invention or not. It is unclear if the “anterior leaflet” is a part of the body or not (and if so, and if it is positively claimed, this claim might receive a 35 U.S.C. 101 rejection). Clarification is accordingly required.
Claim 62 is objected to for referring to “each strut” when it is unclear how, if at all, this relates to the previously claimed “plurality of struts”.
The claim is further unclear for referring to “the other end” with improper antecedent basis.
Claim 64 is unclear for referring to “at least one layer” when it is unclear how, if at all, this relates back to the previously claimed “at least two layers” of claim 54, from which this claim depends.
Claims 63-73 are objected to for referring to “the coaptation assistance system” when the elected invention, of claim 54, refers to a “coaptation assistance element” not a system.
Appropriate correction is required.
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 superior zone, 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.
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 55 and 64 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 pre-AIA the applicant regards as the invention.
Claim 55 is indefinite for claiming the element has “similar physiological hemodynamics” compared with a healthy valve, it is unclear what Applicant considers to be “similar”. The specification does not discuss any specific hemodynamic characteristics of either the coaptation assistance element or the healthy valve, making it unclear exactly what should be similar. Further, the specification does not discuss what values of what specific characteristics should be in order to be considered “similar”. For example, if two values are 10% different, it is unclear if that would be considered “similar” or not. It is unclear where the line being similar and dissimilar would be, and whether or not this would be the same delineation between every physiological hemodynamic (whatever those might be), or whether each hemodynamic characteristic would have different values considered acceptable as being “similar”.
Claim 64 is indefinite for claiming the “at least one layer is configured to be free for at least limited movement” since the layer is presumably attached at some location to the coaptation assistance element, or it would not be part of the element. It is accordingly unclear how this layer can be free and also part of the claimed system element.
This is further indefinite for claiming the layer is free for “limited movement” but it is unclear what Applicant considers to be “limited movement” for example, as opposed to non-limited movement, or no movement. There is no explanation in the specification regarding the amount of movement allowed to be considered limited, or the amount of movement prevented in order to consider the movement limited. Without understanding this, the Examiner cannot understand the boundaries of the claim.
Remaining claims are rejected for depending on a rejected claim.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 54-59, 61-73 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Khairkhahan et al. (US 20180256318 A1) hereinafter known as Khairkhahan.
Regarding claim 54 Khairkhahan discloses a coaptation assistance element for treating mal-coaptation of a heart valve of a heart ([0032]; Figure 47-48; [0028]), the element comprising:
a first lateral edge (475), a second lateral edge (470), an inferior edge (480), and a superior edge (440) ([0032]), and
a superior zone configured to reside in the place of an annulus of the heart valve and an inferior zone extending downward from the superior zone ([0032]),
wherein the inferior zone comprises at least two layers that overlap ([0032] laminate layer, Figure 48 shows all the overlapping layers).
Regarding claim 55 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the element comprises similar physiological hemodynamics compared with a healthy valve (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Khairkhahan discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus, of having “similar” physiological hemodynamics of a healthy valve)
Regarding claim 56 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses one of the layers comprises biological tissue ([0144]).
Regarding claim 57 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses one of the layers comprises a fixed end and a free end (see for example Figure 14, the fixed end of the layer is considered to be near the superior zone near the superior edge, where the layer is fixed within the annulus, and the free end is considered to be near the inferior edge where the end is not fixed within the annulus).
Regarding claim 58 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses one of the layers comprises a partial layer extending between the two lateral edges (Figure 48, for example item 1106).
Regarding claim 59 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers are configured to face the anterior leaflet (Figures 47-48; [0327]).
Regarding claim 61 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses an annular hub (Figures 47-48, item 420; [0033]).
Regarding claim 62 Khairkhahan discloses the coaptation assistance element of claim 61 substantially as is claimed,
wherein Khairkhahan further discloses a plurality of struts (430), wherein each strut has one end terminating at the annular hub and another end extending outwardly towards one of the edges (Figures 5a-b show the struts extending from the hub 520 to the edges).
Regarding claim 63 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses a primary anchor configured to anchor the element to the annulus (800).
Regarding claim 64 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses at least one of the layers is configured to be free for at least limited movement (see for example Figure 14, where the free end is considered to be near the inferior edge where the end is not fixed within the annulus. The layer is considered capable of moving if a strong enough force is applied).
Regarding claim 65 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers comprise different materials ([0145]).
Regarding claim 66 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers comprise different lengths (Figure 48 shows at least two layers of different length, for example layers 1106, 1108).
Regarding claim 67 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers comprise different thicknesses ([0345] posterior layer 1102 is 0.001 inch thick; [0347 layer 1106 is 0.01 inch thick).
Regarding claim 68 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers comprise the same width (Figure 48 shows at least two layers with the same width, for example 1102, 1118).
Regarding claim 69 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the inferior zone comprises more layers than the superior zone ([0032], Figure 48 shows the inferior zone having extra layers 1108, 1112, 1114, 1116).
Regarding claim 70 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the inferior zone is curved between the lateral edges (Figure 47).
Regarding claim 71 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers comprise a continuous layer (1104) and a partial layer (1108).
Regarding claim 72 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses the two layers comprise a partial layer (1108) and one or more additional partial layers (1112).
Regarding claim 73 Khairkhahan discloses the coaptation assistance element of claim 54 substantially as is claimed,
wherein Khairkhahan further discloses one of the layers comprises a polymer ([0144]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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 on 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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