DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 (i.e., changing from AIA to pre-AIA ) 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.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/504,404, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not disclose a first and second stabilizer, along with the needle as presently claimed in claim 1 and illustrated in Figs. 9A-9D of the instant application. Therefore, the effective filing date of claims 1-16 is 10/24/2011 (from Application No. 61/550,772 which first discloses this subject matter).
Claim Objections
Claim 8 is objected to because of the following informalities: “the first side of the heart valve is the atrial side of the heart valve” should recite - - the first side of the targeted leaflet is an atrial side of the targeted leaflet - - to keep the terminology consistent with claim 1. In claim 1, the first side was defined in relation to the targeted leaflet and not the overall heart valve. Appropriate correction is required.
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 1-16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the needle" in line10. There is insufficient antecedent basis for this limitation in the claim. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 1 as - - a needle - -.
Claim(s) 2-16 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 4, 6-9, 11-14 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Davidson (US 2007/0118151).
Davidson discloses the following limitations:
Claim 1. A method (Figs 5-10) for implanting a suture (80) through a leaflet (6) of a heart valve (9), the method comprising:
inserting a shafted instrument (120) between leaflets (4, 6) of a heart valve (9) (Fig. 5; [0087]);
extending a first stabilizer (140) from the shafted instrument to contact a targeted leaflet (6) of the heart valve on a first side (atrial side) of the targeted leaflet (Fig. 6; [0088]);
extending a second stabilizer (170) from the shafted instrument to contact the targeted leaflet on a second side (ventricular side) of the targeted leaflet opposite the first side (Fig. 7; [0088]);
grasping the targeted leaflet with the first stabilizer and the second stabilizer to stabilize the targeted leaflet (Fig. 7; [0088]);
ejecting a needle (180) from the shafted instrument (Figs. 7-8; [0089]); and
penetrating the targeted leaflet with the needle while the targeted leaflet is stabilized by the first stabilizer and the second stabilizer (Fig. 8; [0089]).
Claim 2. The method of claim 1, wherein the heart valve is a mitral valve (9) ([0086]).
Claim 4. The method of claim 1 further comprising extending a snare (88) from the shafted instrument (Fig. 10; [0089]).
Claim 6. The method of claim 4, wherein the snare (88) extends out of the shafted instrument near the first stabilizer (140) (Figs. 9-10, the needle 180 is retracted proximally, thereby pulling suture 80 proximally and out from the distal portion of the first stabilizer 140, therefore snare 88 also extends out and exits from the first stabilizer).
Claim 7. The method of claim 4 further comprising passing the needle (180) through the snare (88) (Figs. 9-10; [0089]).
Claim 8. The method of claim 1, wherein the first side of the heart valve is the atrial side of the heart valve (Fig. 6).
Claim 9. The method of claim 1, wherein grasping the targeted leaflet comprises moving the first stabilizer (140) and the second stabilizer (170) toward each other to grasp the targeted leaflet (between Figs. 5-7 the first stabilizer 140 and second stabilizer 170 are moved towards one another; [0088]).
Claim 11. The method of claim 1, wherein the second stabilizer (170) is configured to be advanced relative to the shafted instrument (120) toward the first stabilizer (140) while the first stabilizer remains stationary relative to the shafted instrument to grasp the targeted leaflet (between Figs. 6-7; [0088]).
Claim 12. The method of claim 1, wherein the shafted instrument includes a shaft (120).
Claim 13. The method of claim 12, wherein the second stabilizer (170) forms a second stabilizer angle relative to the shaft of the shafted instrument of at least 50 degrees (Figs. 7-9).
Claim 14. The method of claim 12, wherein the first stabilizer (140) forms a first stabilizer angle relative to the shaft of the shafted instrument of at least 70 degrees. (Figs. 6-9).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 15 and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Davidson.
Claims 15 and 16. Davidson discloses the invention substantially as claimed above, including the first stabilizer (140) and the second stabilizer (170) forms a substantial first stabilizer angle and substantial second stabilizer angle, respectively, as seen in Figs. 6-9). However, Davidson fails to explicitly disclose wherein the first stabilizer angle is less than or equal to 80 degrees (as per claim 15) and wherein the second stabilizer angle is less than or equal to 60 degrees (as per claim 16). Instead, Davidson discloses the first stabilizer rotates on a rotatable hinge (112) to achieve its angle ([0087]) and the second stabilizer is actuated using an actuator (174) to achieve its angle ([0088]).
There is no evidence of record that establishes that changing the angles of the first stabilizer angle and second stabilizer angle would result in a difference in function of the Davidson method. Further, a person having ordinary skill in the art, being faced with modifying the angles of Davidson would have a reasonable expectation of success in making such a modification and it appears the stabilizers would function as intended being given the claimed angles. In other words, the modification in angle would still alow the first and second stabilizers to ultimately contact the targeted leaflet to thereby grasp and stabilize the leaflet. Lastly, applicant has not disclosed that the claimed range of angles solve any stated problem, indicating that the angles of the stabilizers allow the leaflet to be grabbed by the two stabilizers (see published application [0068]) and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first stabilizer angle is less than or equal to 80 degrees and wherein the second stabilizer angle is less than or equal to 60 degrees as an obvious matter of design choice within the skill of the art.
Allowable Subject Matter
Claims 3, 5, and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten to obviate the 35 U.S.C. 112 rejection as interpreted by the Examiner above.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Davidson, discloses the invention substantially as claimed above.
In regards to claims 3, 5 and 10, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed method for implanting a suture through a leaflet of a heart valve comprising, inter alia, injecting a suture through the targeted leaflet via the needle while the needle is penetrating the targeted leaflet, or the snare is configured to capture a suture injected through the needle, or retracting the needle into the shafted instrument after a suture is injected through the needle. While Davidson teaches delivering a suture (80) through the leaflet, the suture is instead delivered through the first stabilizer (140) and the needle (180) is used to engage a cuff (84) on the suture to thereby draw the suture proximally. The needle structure of Davidson is not capable of injecting a suture as the needle contains no lumen to allow a suture to be injected therethrough. The needle of Davidson is retracted into the shafted instrument (Fig. 10) but not after a suture is injected through the needle as the suture of Davidson is never injected through the needle as discussed above.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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