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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/26 has been entered.
Response to Arguments
Applicant's arguments filed 05/27/26 have been fully considered but they are not persuasive.
On page 6 regarding drawing objections, Applicant argues amendments to the claim overcome the drawing objections.
The Examiner respectfully disagrees, noting as Applicant points out in their response that item 400 appears to be drawn towards a “laser-cut electrospun heart valve shape” and not towards a “single electrospun tubular structure”. Additionally, while Applicant argues the top and bottom edges are shown by items 210, the specification appears to refer to these as “curved edges”, as opposed to distinct top and bottom edges, or even, as would now be required by amended claims, top and bottom edges. The drawing objections are accordingly maintained.
On page 6 regarding 112b rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully disagrees, noting 112 rejections which were not addressed are maintained.
On page 7 regarding prior art rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claim limitations.
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 “first edge”, the “second edge”, “notched structures” and “notch structures” 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, 11 are objected to because of the following informalities:
Claim 7 is objected to for referring to “the fold” and “the notch structures” with improper antecedent basis.
Further, the claim is unclear for referring to “a folded edge” when it is unclear how, if at all, this relates to the previously defined “fold”.
Further, the claim is unclear for claiming “the folded edge is a free edge one or more leaflets of the engineered heart valve” since it appears this is grammatically incorrect/words are missing.
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.
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 7-12 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 7 is rejected for having new matter for claiming the single electrospun tubular structure has “notched structures distributed across the single electrospun tubular structure” such that notched structures are positioned at the fold. There is no support in the originally filed disclosure for there being “notched structures”, let alone their distribution or positioning at the fold. This is accordingly considered to be new matter.
Remaining claims are rejected for depending on a claim with new matter.
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.
Claim 8 is 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 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.
Remaining claims are rejected for depending on an indefinite 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 Colavito et al. (US 20190125529 A1) hereinafter known as Colavito, further in view of Jana et al. (US 20160317295 A1) hereinafter known as Jana.
Regarding claim 7 Rolando discloses an engineered heart valve (Abstract) comprising:
a single tubular structure (Figure 5a) with a first edge (top of tube T) and a second edge (bottom of tube T), wherein the structure is folded over itself in a direction of a longitudinal axis thereof (Figure 12), the first edge meets the second edge (Figure 12), resulting in a bi-layered design with a folded edge (Figure 12),
and wherein the folded edge is a free edge one of the leaflets (Figures 14-15),
but is silent with regards to the tubular structure being electrospun,
and the tubular structure having notches structures.
However, regarding claim 7 Colavito teaches a method of manufacturing a folded heart valve which relies upon notches structures at a fold (Figure 7a item 706; [0086]). Ronaldo and Colavito 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 Ronaldo so that Ronaldo’s folded leaflet edges include notches such as is taught by Colavito in order to help with the alignment of the fold during manufacture (Colavito [0086]).
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 the Rolando Colavito Combination 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 Colavito Jana Combination teaches the valve of claim 7 substantially as is claimed,
wherein Rolando further discloses only the first and second edges are attached and incorporated to a base of the valve (Figure 15 item 20 shows the attachment).
Regarding claim 9 the Rolando Colavito 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, Colavito, and 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 Colavito 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 Colavito 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 Colavito 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 Colavito 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
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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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 06/08/26
