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 .
Response to Arguments
Applicant's arguments filed 07/24/26 have been fully considered but they are not persuasive.
On page 5 regarding claim objections Applicant argues amendments overcome the objections to the claims.
The Examiner respectfully withdraws the objections which were addressed, but maintains the objections which were not addressed. Please also see below for additional objections made in light of amended claims.
On page 5 regarding drawing objections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully notes amended drawings are not entered, since figure 2 appears to include new matter, by creating a dotted line and labeling it the expected breaking position. Some of the other drawing objections would have been overcome, if entered however. Please also see below regarding the claimed subject matter still not shown, made in light of the amended claims.
On page 6 regarding 101 rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully agrees and withdraws 101 rejections.
On page 6 regarding 112 rejections Applicant argues amendments overcome the 112 rejections of record.
The Examiner respectfully withdraws the rejections which were addressed, but maintains the rejection which was not addressed. Please also see the 112 rejection below made in light of amended claims.
On pages 7-8 regarding prior art rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
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 three valve leaflets, the three regions of the fixing stent, the three junctions of three leaflets with the fixing stent, the valve annulus plane, the bent portion, the corresponding stretching part, the other portions of the corresponding stretching part, the annular mesh, the petal-shaped protruding parts, the network structure, the diameter of the support buckle structure and the diameter of the corona structure, the valve annulus and its diameter, the stretching part being broken, the inflow and outflow support structures being integrally formed (the figures appear to show these structures as being very distinct from one another and not even connected), the corona and support buckle (as compared to the corona structure and support buckle structure, should they be distinct), 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: bent portion, annular mesh.
Claim Objections
Claims 1, 3, 6, 9-12 are objected to because of the following informalities:
Claim 1 is objected to for referring to “three leaflets” and “the corresponding stretching part” with improper antecedent basis.
Claim 3 is objected to for referring to “a nickel-titanium alloy” when it is unclear how this relates to the previously claimed nickel-titanium alloy (if at all).
Claim 6 is objected to for referring to “the number” with improper antecedent basis.
Claims 9-10 are objected to for referring to “a corona” and “a support buckle” when it is unclear how, if at all, these relate to the previously claimed “support buckle structure” and “corona structure”.
Claim 11 is objected to for referring to “coronas” when it is unclear how, if at all, this relates back to the previously claimed “corona structure”.
Claim 12 is objected to for referring to “support buckles” when it is unclear how, if at all, this relates back to the previously claimed “support buckle structure”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-7, 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter, since the originally filed disclosure fails to have support for there being a “silicone” suture ring. There is no mention of silicone in the originally filed disclosure.
Remaining claims are rejected for depending on a claim with new matter.
Claims 1-3, 6-7, 9-13 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 1 is indefinite for claiming the inflow/outflow support structures are “formed by…integral cutting”, but it is unclear what “integral cutting” means. While the specification states the corona and support buckle are “manufactured by adopting an integral forming and internal cutting mode”, this is the only part integral cutting is mentioned. Integral cutting is not a term known in the art, or by the Examiner, and it is unclear what such a term might entail and how it might relate to forming the inflow/outflow structures. This claim is accordingly unclear, since the Examiner is unsure on what integral cutting might be.
Claim 2 is indefinite for claiming the support structures are “support buckle structures”. “Buckle” is defined by Merriam-Webster as “a fastening for two loose ends that is attached to one and holds the other by a catch; an ornamental device that suggests a buckle”. Neither of these two definitions appears to match Applicant’s “support buckle structure”, which is neither a fastening, nor shaped/ornamented such as one. The Examiner is unclear what exactly would be required structurally and/or functionally for the support structure(s) of the claim to be considered “support buckle structures”, since the specification does not elaborate on the term, its definition, or what would be/would not be considered a support buckle structure. The figures appear to just show a stent, making this even more unclear.
Further, the claim is unclear for claiming the support buckle structure is “petal-shaped” when the figures do not appear to show the support buckle structure being “petal shaped”, but rather including petal shapes. The buckle itself being petal-shaped would indicate for example, a single petal shape, which is contrary to what is shown in the figures as originally filed. It is unclear accordingly, how to interpret this claim. For the purposes of examination, the Examiner will understand the support buckle to include petal shapes.
Remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 6-7, 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink et al. (US 20210186689 A1) hereinafter known as Eidenshink in view of Marchand et al. (EP 2896387 A1) hereinafter known as Marchand.
Regarding claim 1 Eidenschink discloses a self-expanding ([0062]) biological ([0038]) valve comprising:
a fixing stent (Figures 16-19 item 1400) comprising three stretching parts (Figures 16-19 item 1420) respectively positioned below three regions of the fixing stent that correspond to junctions of three valve leaflets with the stent (Figures 16-18 shows item 1420 at the lower edge of the leaflet junctions 1406. See also [0047] the slit portion 1416 is positioned below commissure posts, indicating that the commissure post/junction 1406 has its lower edge position where the stretching element 1420 is located), wherein each of the three stretching parts has a bent portion having a smaller cross-sectional area than that of other portions of the corresponding stretching part (Figures 16-17; [0047]) configured to break under radially outward expansion force applied to the stent thereby allowing the stent to expand outwardly after the stretching parts are broken (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Eidenschink was considered capable of performing the cited intended use of having the stretching part broken via the force described, if desired, and the ring is considered able to be further expanded if desired),
and a silicone gel ([0036]) suture ring (Figure 2 item 210; see also [0039] the valve of Eidenshink can include the sewing cuff/ring) arranged at a position corresponding to a valve annulus plane position on the stent (Figure 2. The position of the ring 210 is understood to be at a “valve annulus plane position” since it can be implanted at an annulus if desired.),
and three valve leaflets ([0005]; Figure 2 items 230 (see also [0039] the valve of Eidenshink can include the three leaflets)),
but is silent with regards to there being an inflow end support structure and an outflow end support structure which extend outwardly and are formed integrally with forming and cutting.
However, regarding claim 1 Marchand teaches that a heart valve can include an inflow end support structure (Figure 2 item 2) and an outflow end support structure (Figure 2 item 3) arranged on the [inner valve structure] (Figures 7b-c item 13), so when the support structures are in an unfolded state, the support structures extend outwardly relative to the stent in a radial direction (Figures 2 and 7a-c) and are configured to support the valve relative to a valve annulus (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 Marchand discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example the Abstract as well as Figures 8-9.) and to apply a force to an area adjacent thereto (this is likewise stated as a functional limitation. See also [0085] the device is capable of being sized in order to ensure pressure on all tissues to prevent slipping). Eidenschink and Marchand are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Eidenschink by having an inflow and outflow support structure as is taught by Marchand in order to help the valve secure in place without moving during the beating of the heart, thus lengthening the lifespan of the valve as a whole.
Further, regarding claim 1 Marchand further teaches the inflow and outflow support structures are formed by integral forming and integral cutting (The applicant is advised that this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. See MPEP 2113. In this case, the cited limitations failed to distinguish the claimed structure from Marchand, since all the structural limitations of the claim appear to be met. See for example [0014]: the anchoring structure, including both its inner and outer walls, are a single piece). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to further modify the Eidenschink Marchand Combination so that the support structures are integrally formed as is taught by Marchand since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the choice to manufacture the structures via any known method would have been obvious to the person of ordinary skill to try.
Regarding claim 2 the Eidenschink Marchand Combination teaches the valve of claim 1 substantially as is claimed,
wherein Marchand further discloses the support structures are support buckle structures or corona structures (“corona” is defined by Merriam-Webster as “something suggesting a crown”) (Figure 2 shows how both support structures can be considered to be crown-like), the buckle being petal-shaped (Figures 1, 7c show how many tiny petals, one representing each apex turn of teh wire, can be seen protruding outwardly in petal shapes) and the corona being an annular mesh (Figures 1 and 7a-c show the support sturctures comprising annular mesh).
Regarding claim 3 the Eidenschink Marchand Combination teaches the valve of claim 2 substantially as is claimed,
wherein Marchand further teaches the support buckle structure is made of a nickel titanium alloy material ([0013]) and provided with petal-shaped protruding parts extending outwards in the radial direction in the unfolded state (Figures 1, 7c show how many tiny petals, one representing each apex turn of the wire, can be seen), and
the corona has a network structure (Figure 1) of a nickel titanium alloy material ([0013]), and in an unfolded state, a diameter of the corona is larger than that of the valve annulus thereby preventing displacement (this depends on the size of the annulus into which it is implanted as opposed to structurally changing the claimed corona. See also Figures 8-9 however.). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Combination so that the support structures are made of a nickel titanium material as is taught by Marchand since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. It would have further been obvious to one of ordinary skill to have the support structures shaped as is taught by Marchand in order to ensure they are dimensioned appropriately to maintain the level of support needed to hold the inner heart valve and its stent in place as Marchand teaches is desirable.
Regarding claim 6 the Eidenschink Marchand Combination teaches the valve of claim 3 substantially as is claimed,
wherein Marchand further teaches there are three or more protruding parts of the support buckle (Figure 7c shows how there are more than three protruding parts, each protruding part being formed by each apex turn of the wire forming the buckle),
and wherein the protruding parts are circumferentially distributed on a circumference of the stent (Figures 1 and 7b-c).
Regarding claim 7 the Eidenschink Marchand Combination teaches the valve of claim 1 substantially as is claimed,
wherein Eidenschink further discloses the stent is made of metal or polymer ([0032]).
Regarding claim 9 the Eidenschink Marchand Combination teaches the valve of claim 2 substantially as is claimed,
wherein Marchand further teaches the inflow support structure is a corona, and the outflow end structure is a support buckle (Figure 1 and 7c).
Regarding claim 10 the Eidenschink Marchand Combination teaches the valve of claim 2 substantially as is claimed,
wherein Marchand further teaches the inflow support structure is a support buckle, and the outflow end structure is a corona (Figure 1 and 7c).
Regarding claim 11 the Eidenschink Marchand Combination teaches the valve of claim 2 substantially as is claimed,
wherein Marchand further teaches the inflow and the outflow end structures are both coronas (Figure 1 and 7c).
Regarding claim 12 the Eidenschink Marchand Combination teaches the valve of claim 2 substantially as is claimed,
wherein Marchand further teaches the inflow and the outflow end structures are both support buckles (Figure 1 and 7c).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink in view of Marchand as is applied above, or in the alternative, over Eidenschink in view of Marchand, further in view of Pellegrini et al. (US 20110238168 A1) hereinafter known as Pellegrini.
Regarding claim 13 the Eidenschink Marchand Combination teaches the valve of claim 6 substantially as is claimed,
wherein Eidenschink further discloses the number of the petal-shaped protruding parts of the support buckle is a multiple of three (Figure 7c shows how there are at least three protruding parts (three is a multiple of three). The inclusion of more petal-shaped protruding parts is understood to be allowed, in a non-consisting claim. Alternatively, Pellegrini, who is within the valve field of endeavor, same as Eidenschink, teaches a number of petal-shaped protruding parts on a stent being a multiple of three (Figure 13 shows six crowns). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the number of petal-shaped protruding parts so there are any number, including a multiple of three as is taught by Pellegini since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A).).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 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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