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 03/23/26 have been fully considered but they are not persuasive.
On pages 9-10 Applicant argues drawing, claim and specification objections are overcome.
The Examiner respectfully notes that the addressed objections are withdrawn, but notes that claim, figure, and specification amendments have created multiple new objections which are described below. Additionally, the unaddressed objections are maintained.
On pages 11-12 Applicant explains their amendments regarding 112b rejections.
The Examiner respectfully notes amendments did not address all 112b rejections, and so some are maintained. Additionally, amendments created additional 112b rejections (see below).
On pages 15-16, regarding prior art rejections Applicant argues amendments overcome the rejection of record since Ramlawi fails to teach the first and second leaflet, the larger recess, and the outer edge. Applicant argues further that Ramlawi fails to teach the two leaflet recesses.
The Examiner respectfully disagrees, pointing out all the structural features required by the claims are taught by Ramlawi and/or teaching references, as is indicated below.
On page 16 Applicant argues further that the folding of leaflets seen in figure 5c can’t cover the entire area of the aorto-mitral curtain, meaning Ramlawi’s patch cannot replace the curtain.
The Examiner respectfully notes no requirement in the claim for “covering the entire area of the aorto-mitral curtain”, or replacing the entire curtain as Applicant is arguing. There is further no evidence provided in the record by the Applicant to support the statements made above.
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 “frame of the inner layer of the atrio-ventricular junction of the human heart”, the central line, markings for the positions of the commissures, the leaflet ending of the right aortic annular part that includes the aortic valve, the unextended cardiac aorto-mitral prosthesis, the recess extension being marked by a visible line over the recess ending, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because:
-Figure 1 shows items 11, 14, 15 all pointing to two different objects in the figures
-Figure 33 item 30b is pointing to two different structures
-item 25c, 25 are both used to represent the aorto-mitral curtain
-item 25c is used to represent both aorto-mitral curtain and middle part
-[0137], [1039] both reference the angle alpha, but this angle is not in the figures being described
-[0140] references the wall incision 27b but this isn’t in figure 30
-Figure 35 has most of its numbers cut off and difficult to read
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 1, 3-8 are objected to because of the following informalities:
Claim 1 is objected to for referring to “a human heart” multiple times with improper antecedent basis, as well as “an aorto-mitral curtain”.
Further, the claim is unclear for claiming “a cardiac aorto-mitral prosthesis for replacing a cardiac aorto-mitral curtain of a human heart in anatomic shape”. First, it appears a word is missing between “in” and “anatomic”. Further however, this is unclear because it isn’t known what has the anatomic shape (the cardiac aorto-mitral prosthesis, the cardiac aorto-mitral curtain, or the human heart).
The claim is also objected to for including an extraneous word (“a”) on line 7 before “placement”. There is also an extraneous word (“an”) in lines 11 and 12 before the word “inclusion”. The dual recitation of “an inclusion” makes the word “inclusion” a noun, when the Examiner believes this is intended to represent a verb in the claims.
Claims 3-8 are objected to for all referring to “a human heart” with improper antecedent basis.
Claim 3 is also objected to for referring to “an aortic valve” and “a mitral valve” with improper antecedent basis.
Claim 6 is objected to for also referring to “an aortic valve” and “a tricuspid valve annulus” with improper antecedent basis.
Claim 7 is objected to for also referring to “an ending of the first leaflet”, “an aortic valve”, and “a tricuspid valve annulus” with improper antecedent basis.
Claim 8 is objected to for also referring to “a mitral valve annulus” with improper antecedent basis.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
[0015] states “a pericardial patch as a patch that serves” when it appears the words “as a patch” are unnecessary/unclear.
[0021] states “the mental partition as a partition that separates” when it appears the words “as a partition” are unnecessary/unclear.
Appropriate correction is required.
The amendment filed 03/23/26 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
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Applicant is required to cancel the new matter in the reply to this Office Action.
Further, 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification appears to be a direct machine translation of a foreign document, and so contains terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112.
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 1-12 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 1 is indefinite for claiming there is “one larger recess over both leaflets of the” prosthesis, but it is unclear how there is a recess “over” the leaflets, when the only structure actually present in the claims for the prosthesis is the patch which is made into the leaflets. It is accordingly unclear what has this “one larger recess”, where it is, and how it is positioned “over” the leaflets.
Further, the claim is unclear for claiming there is an “outer edge on an opposite side to the larger recess of the cardiac aorto-mitral prosthesis” when the claim has identified this previously as being “over” the leaflets, making it unclear what has the outer edge, and what has the opposite side. Since the recess is above the leaflets and not a part thereof, it appears whatever has the outer edge and recess is not claimed, making the Examiner unclear on how to examine this claim.
The claim is further indefinite for claiming the first leaflet recess “is configured for an inclusion of the aortic valve annulus” and the second leaflet recess “is configured for an inclusion of the mitral valve annulus” when it is unclear what it means for recesses to “serve for the inclusion” of a valve annulus. The claim is drawn towards a “prosthesis”, making it unclear how the aortic valve annulus and mitral valve annulus are to be “included”, and exactly what “inclusion” means in the context of this claim.
The claim is further indefinite for claiming the larger recess is “configured for supporting the tricuspid valve annulus”, since as the Examiner best understands, a recess does not lend support to something (since it represents the lack of material).
The claim is further unclear for its last 3 lines, since as the Examiner best understands, the atrio-ventricular junction of the heart does not include a “frame” or an “inner layer”. The figures do not elaborate on what these structures might be, and this is not a known term/body part.
Claim 4 is indefinite for claiming an aortic wall of an aorta “of a human heart”. This is unclear, since a heart does not include an aorta. The aorta is understood to be a blood vessel external to, and connecting to the human heart.
Further, the claim is indefinite for claiming either the “third leaflet”, “prosthesis”, or “partition” (it is unclear which from the wording of the claim) is “configured for a covering of an aortic wall”. It is unclear if this means that the third leaflet/prosthesis/partition is intended to be a covering of the aortic wall, or whether this is claiming the third leaflet/prosthesis/partition is attached to the partition for a covering, which is a covering of the aortic wall.
Claim 5 is indefinite for claiming either the “fourth leaflet”, “prosthesis”, or “partition” (it is unclear which from the wording of the claim) is “configured for a replacement of a left atrial roof”.
Claim 6 is indefinite for referring to “a right aortic annular part of a human heart” but this is not a known part of the human heart, and it isn’t clear what part of the human heart this is intended to represent.
Claim 8 is indefinite for referring to “an unextended patch of the cardiac aorto-mitral prosthesis” when it is unclear how, if at all, this relates to the previously claimed “patch” from claim 1. The Examiner notes the patch of claim 1 is not able to extend (or be non-extended), which makes this claim unclear. There is likewise no comparison or explanation as regards how the “recess extension” or “recess ending” of the second leaflet corresponds (if at all) to the previously claimed “larger recess” of the second leaflet, making it unclear if these are related, the same, different, or unrelated.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 102
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) 1-2, 4-6, 8-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ramlawi et al. ("Endocarditis with Involvement of the Aorto-Mitral Curtain"; Operative Techniques in Thoracic and Cardiovascular Surgery, vol. 16, no. 3, pages 242-249. XP028392709, ISSN: 1522-2942, DOI: 10.1053/J.OPTECHSTCVS.2011.09.004), hereinafter known as Ramlawi.
Regarding claim 1 Ramlawi discloses a cardiac aorto-mitral prosthesis for replacing a cardiac aorto-mitral curtain of a human heart in anatomic shape for a human heart and forming a prosthesis for the aorto-mitral curtain of the heart (page 245 “defect in the aorto-mitral curtain” indicates part of the curtain is replaced), made of a patch (page 244 “a patch repair using pericardium can be done”), the prosthesis comprising:
the patch (page 244 “a patch repair using pericardium can be done”), separated by a partition that is a central line and separates the prosthesis into two leaflets including a first leaflet and second leaflet (e.g. considered to be two halves of the repair prosthesis (see the annotated figure below)) for placement of the prosthesis between an aortic and mitral valve during a surgical operation in the heart (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 Ramlawi was considered capable of performing the cited intended use. See, for example page 248),
wherein the first leaflet has a first recess which is configured for an inclusion of the aortic valve annulus, and the second leaflet has a second recess which is configured for an inclusion of the mitral valve annulus (see the annotated figure, along with Figure 1c which shows how recesses in the curtain are for the valves),
having over both leaflets of the prosthesis, one larger recess which is configured for supporting a tricuspid valve annulus (see the annotated figure; the larger recess is understood to be the recess created by the shape of the leaflets joining together), and
on the opposite side of the larger recess over both leaflets, an outer edge which is configured to support a frame of an inner layer of the atrio-ventricular junction of the heart (see the side opposite the larger recess in the annotated figure).
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Regarding claim 2 Ramlawi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Ramlawi further discloses the partition is marked by a visible line or folding (see the annotated figure; there is a line of stitching).
Regarding claim 4 the Examiner notes Applicant has admitted a three-leaflet embodiment is not patentably distinct from one having two. Since the two leaflets are disclosed by Ramlawi this claim is also understood to be non-patentable. Additionally, a third leaflet being “attached” to the claimed prosthesis does not structurally limit the claimed prosthesis.
Regarding claim 5 the Examiner notes Applicant has admitted a four-leaflet embodiment is not patentably distinct from one having two. Since the two leaflets are disclosed by Ramlawi this claim is also understood to be non-patentable. Additionally, a fourth leaflet being “attached” to the claimed prosthesis does not structurally limit the claimed prosthesis.
Regarding claim 6 Ramlawi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Ramlawi further discloses a first leaflet extension that extends a first leaflet ending for replacement of a right aortic annular part that is configured for embracing the aortic valve and is configured for giving room and engaging with the tricuspid valve annulus (at least a tip part of the first leaflet can be considered to be an “extension”.).
Regarding claim 8 the Examiner notes that Applicant has admitted the recess extension being present is not patentably distinct from no recess extension. Since no recess extension is understood to be disclosed by Ramlawi, this claim is likewise understood to be non-patentable.
Regarding claim 9 the Examiner notes that Applicant has admitted a the recess extension being present is not patentably distinct from no recess extension. Since no recess extension is understood to be disclosed by Ramlawi, this claim is likewise understood to be non-patentable.
Regarding claim 10 Ramlawi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Ramlawi further discloses an artificial mitral valve prosthesis attached to the prosthesis (this does not appear to materially affect the structure of the claimed prosthesis).
Regarding claim 11 Ramlawi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Ramlawi further discloses an artificial aortic valve prosthesis attached to the prosthesis (this does not appear to materially affect the structure of the claimed prosthesis).
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 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramlawi as is applied above in view of Aklog et al. (US 20160113769 A1) hereinafter known as Aklog.
Regarding claim 3 Ramlawi discloses the prosthesis of claim 1 substantially as is claimed,
but is silent with regards to there being markings on the prosthesis to mark positions of commissures of an adjacent valve.
However, regarding claim 3 Aklog teaches markings can be present on prostheses in the heart to represent positions of commissures of the aortic or mitral valve ([0061]). Ramlawi and Aklog are involved in the same field of endeavor, namely heart valve prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Ramlawi to include markings as is taught by Aklog in order to help the implanting physician to orient the implant appropriately during surgery, thus increasing the likelihood of success of the surgery and make it easier.
Claim 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramlawi as is applied above in view of Fish et al. (US 20120185038 A1) hereinafter known as Fish.
Regarding claim 7 Ramlawi discloses the prosthesis of claim 6 substantially as is claimed,
but is silent with regards to the extension being marked by a folding or visible line.
However, regarding claim 7 Fish teaches heart valve prostheses can include visible lines or foldings within a leaflet (Figure 1a-b). Ramlawi and Fish are involved in the same field of endeavor, namely heart valve prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the prosthesis of Ramlawi so that there is a visible line on the prosthesis to separate the “extension” from the first leaflet in order to help facilitate easy implantation by the surgeon.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramlawi as is applied above in view of Murphy et al. (US 20040249408 A1) hereinafter known as Murphy.
Regarding claim 12 Ramlawi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Ramlawi further discloses the prosthesis comprises pericardium (Figure 246 describes the patch being made of pericardium),
but is silent with regards to the pericardium being from a bovine.
However, regarding claim 12 Murphy teaches heart repair devices can include pericardium from a bovine source ([0080]). Ramlawi and Murphy are involved in the same field of endeavor, namely heart repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the source of the pericardium of Ramlawi so that it comes from a bovine origin as is taught by Murphy 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 use of pericardium from any known successful source would have been obvious to try.
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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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 04/07/26