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 11/13/25 have been fully considered but they are not persuasive.
On pages 8-9 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 single electrospun tubular structure, the top edge, and the bottom edge 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 Objections
Claims 7, 9, and 11 are objected to because of the following informalities:
Claim 7 is objected to for the phrase “therewith being” since it is unclear what this means. It appears there is either missing punctuation, a missing word, and/or the wrong word.
Claim 9 is objected to for appearing to miss punctuation and/or a word after “bioabsorbable”.
Claim 11 is objected to for referring to “pores” multiple times without making it clear whether or not the pores referenced are all referring to the same pores or whether these are distinct pores.
The claim is similarly objected to for referring to “natural tissue”, “cells”, and “nutrients” multiple times with improper antecedent basis.
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 7-12 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 7 is indefinite for claiming “an engineered heart valve with one or more leaflets comprising” since it is unclear whether the remainder of the claim is describing the engineered heart valve, or the leaflets.
Claim 8 is indefinite for claiming the top and bottom edge are “incorporated to” a base of the heart valve, since it is unclear what this means, and whether or not the claim intends the two edges to be incorporated into a base, onto a base, or are somehow formed into a base, attached to a (distinct) base, or some other explanation.
Further, the claim is unclear for claiming the bi-layered design allows “independent movability” when this is unclear, since by nature, the bi-layer design includes two layers which are attached to one another. This inherently means that the two layers are not independently moveable, but in contrast, have at least one location in which the movement of one of the layers influences movement of the other layer.
The claim is further indefinite for referring to “the bi-layered design in each of the one or more leaflets” but it doesn’t appear that the leaflets have a bi-layered design – the claim indicates that the tubular structure has a bi-layered design but not the leaflets.
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.
Claims 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rolando et al. (WO 2017013578 A1) hereinafter known as Rolando in view of Jana et al. (US 20160317295 A1) hereinafter known as Jana.
Regarding claim 7 Rolando discloses an engineered heart valve (Abstract) with one or more leaflets (14a-c) comprising:
a single tubular structure (Figure 5a) with a top edge (top of tube T) and a bottom edge (bottom of tube T), wherein the structure is folded over itself in a direction of a longitudinal axis thereof (Figure 12) such that the top edge meets the bottom edge (Figure 12), thus forming a bi-layered design with a folded edge (Figure 12),
wherein the folded edge is a free edge of one of the leaflets (Figures 14-15),
but is silent with regards to the tubular structure being electrospun,
Further, regarding claim 7 Jana teaches a heart valve which includes a leaflet which includes multiple layers which are electrospun ([0009]). Rolando and Jana are involved in the same field of endeavor, namely 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 Rolando by having the leaflet material be electrospun as is taught by Jana since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, it would be obvious to substitute any known type of leaflet microstructure that is known in the art.
Regarding claim 8 the Rolando Jana Combination teaches the valve of claim 7 substantially as is claimed,
wherein Rolando further discloses the top and bottom edges are attached and incorporated to a base of the valve (Figure 15 item 20 shows the attachment) allowing for independent moveability of the bi-layered design (this is considered to be inherent within the structure of Rolando).
Regarding claim 9 the Rolando Jana Combination teaches the valve of claim 7 substantially as is claimed,
wherein Jana further teaches the leaflet is porous (see Figures 6, 10 which show the pore openings inherently formed by the electrospinning process) and bioabsorbable ([0009] PCL, PGA, PLGA etc. are all bioabsorbable materials), so the leaflet is capable of being absorbed and replaced by natural tissue due to ingrowth of cells and nutrients into pores (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 the Combination teaches (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus.).
Claims 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rolando in view Jana as is applied above, further in view of of L’Heureaux et al. (US 20150088247 A1) hereinafter known as L’Heureaux.
Regarding claim 10 the Rolando Jana Combination teaches the valve of claim 7 substantially as is claimed,
but is silent with regards to there being a middle layer in between the bi-layered design that is independently moveable from the bi-layer.
However, regarding claim 10 L’Heureaux teaches a heart valve which includes a middle layer in between a bi-layered design ([0079]),
wherein the middle layer remains independently movable from the bilayer design ([0079]). Rolando and L’Heureaux are involved in the same field of endeavor, namely prosthetic 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 the Rolando Jana Combination to have a middle layer as is taught by L’Heureaux in order to provide an extra layer in the leaflet to increase durability and strength thereof, which can increase the amount of time the leaflet is functional after implantation.
Regarding claim 11 the Rolando Jana L’Heureaux Combination teaches the valve of claim 10 substantially as is claimed,
wherein Jana further teaches the middle layer is porous (see Figures 6, 10 which show the pore openings inherently formed by the electrospinning process) and bioabsorbable ([0009] PCL, PGA, PLGA etc. are all bioabsorbable materials), so the middle layer is capable of being absorbed and replaced by natural tissue due to ingrowth of cells and nutrients into pores (this is stated as a functional limitation (see the explanation in the rejection to claim 9 above).
Regarding claim 12 the Rolando Jana L’Heureaux Combination teaches the valve of claim 10 substantially as is claimed,
wherein Jana further teaches all the layers are electrospun ([0009]).
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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/03/25