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 .
Claim Objections
Claim 32 is objected to because of the following informalities: Claim 32 recites the limitation of “and the method of claim 1 via the deployed actuator device.” The claim must be amended “and perform the method of claim 1 via the deployed actuator device.”, or similar. 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 18-32 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner contends that applicant fails to provide adequate written description for the breadth of the claim. Specifically, the limitation “augmenting displacement of an atrioventricular plane of a heart” in claim 18 are broad enough to encompass any way imaginable that an augmenting displacement of an AV plane could work. Dependent claims 19-32 are rejected for depending on claim 18, and failing to remedy the same deficiency.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 18-24 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210275295 to Tozzi.
Regarding claim 18. (Original) Tozzi discloses a method for improving heart function comprising: augmenting displacement of an atrioventricular plane of a heart (abstract, para 0005, 0024, etc. “alter the shape of mitral valve annulus”).
Regarding claim 19. (Original) Tozzi discloses the method of claim 18, wherein the displacement comprises movement along an axis substantially perpendicular to the atrioventricular plane (para 0024 displacement of the posterior leaflets towards the anterior,”, which would be perpendicular to the AV plane).
Regarding claim 20. (Original) Tozzi discloses the method of claim 18, wherein the displacement is initiated by an actuator (e.g., para 0024 “device”, 0025 “annuloplasty device”).
Regarding claim 21. (Original) Tozzi discloses the method of claim 20, wherein the actuator is coupled to the heart (abstract, para 0024-0025).
Regarding claim 22. (Original) Tozzi discloses the method of claim 20, wherein actuator is coupled to a top portion of the heart (abstract, para 0024-0025, figs 5-12).
Regarding claim 23. (Original) The method of claim 20, wherein the actuator is coupled to the heart via a fibrous ring (abstract, para 000024-0025, etc.” one or more wires may be anchored on one extremity to an element positioned along the posterior part of the mitral annulus”).
Regarding claim 24. (Original) Tozzi discloses the method of claim 20, wherein the actuator is disposed substantially along the axis (abstract, para 0024-0025, figs 5-12).
Regarding claim 29. (Original) Tozzi discloses the method of claim 18 further comprising: changing a ring geometry within the atrioventricular plane (para 0024 “alter the shape of mitral valve annulus”).
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over different embodiments of US 20210275295 to Tozzi.
Regarding claim 32. (Currently Amended) Tozzi discloses a transcatheter method for improving heart function comprising: advancing a catheter though a vascular system towards a heart (para 0033, 0035); deploying an actuator device from a distal opening of the catheter (para 0033, 0035); retracting the catheter through the vascular system (para 0035 “the delivery catheter 510 may be retrieved and the procedure completed”); and .
Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over different embodiments of US 20210275295 to Tozzi in view of US 6221103 to Melvin.
Regarding claim 25. (Original) Tozzi discloses the method of claim 18 further teaching that in order to close properly, the free edges of the two leaflets have to touch each other over a length of several millimeters (para 0005) but fails to explicitly disclose augmenting displacement of the atrioventricular plane between 1 millimeter and 7 millimeters.
Melvin, from a similar field of endeavor teaches that it is known for the heart needs to be displaced or moved inwardly about 6.2mm from the unrestrained position to achieve the desired restructure or reconfiguration (Col 12, lns 27-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Tozzi with the known teaching of Melvin to provide the predictable result of displacing the heart to achieve the desired restructure or reconfiguration. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 26. (Original) Tozzi discloses the method of claim 18 further teaching that in order to close properly, the free edges of the two leaflets have to touch each other over a length of several millimeters (para 0005) but fails to explicitly disclose: augmenting displacement of the atrioventricular plane between 3 millimeters and 7 millimeters.
Melvin, from a similar field of endeavor teaches that it is known for the heart needs to be displaced or moved inwardly about 6.2mm from the unrestrained position to achieve the desired restructure or reconfiguration (Col 12, lns 27-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Tozzi with the known teaching of Melvin to provide the predictable result of displacing the heart to achieve the desired restructure or reconfiguration. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 27. (Original) Tozzi discloses the method of claim 18 further teaching that in order to close properly, the free edges of the two leaflets have to touch each other over a length of several millimeters (para 0005) but fails to explicitly disclose: augmenting displacement of the atrioventricular plane between 5 millimeters and 7 millimeters.
Melvin, from a similar field of endeavor teaches that it is known for the heart needs to be displaced or moved inwardly about 6.2mm from the unrestrained position to achieve the desired restructure or reconfiguration (Col 12, lns 27-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Tozzi with the known teaching of Melvin to provide the predictable result of displacing the heart to achieve the desired restructure or reconfiguration. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 28. (Original) Tozzi discloses the method of claim 18 further teaching that in order to close properly, the free edges of the two leaflets have to touch each other over a length of several millimeters (para 0005) but fails to explicitly disclose: augmenting displacement of the atrioventricular plane by about 7 millimeters.
Melvin, from a similar field of endeavor teaches that it is known for the heart needs to be displaced or moved inwardly about 6.2mm from the unrestrained position to achieve the desired restructure or reconfiguration (Col 12, lns 27-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Tozzi with the known teaching of Melvin to provide the predictable result of displacing the heart to achieve the desired restructure or reconfiguration. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over different embodiments of US 20210275295 to Tozzi in view of US 20190076250 to Hjelle et al. (hereinafter “Hjelle”).
Regarding claim 30. (Original) The method of claim 18 but fails to disclose further comprising: augmenting movement of a papillary muscle for generating rotational movement.
Hjelle, from a similar field of endeavor teaches using a second fillable bladder to exert localized pressure on the wall of the heart to counteract the effects of displaced papillary muscles distorted LV (para 0176). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Tozzi with the teachings of Hjelle to provide the predictable result of counteracting the effects of displaced LV.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over different embodiments of US 20210275295 to Tozzi in view of US 20040267086 to Anstadt et al. (hereinafter “Anstadt”).
Regarding claim 31. (Original) The method of claim 18 further comprising: but fails to disclose augmenting movement of both the left and right ventricles.
Anstadt, from a similar field of endeavor teaches displacing both the left and right liner portions of the heart [] to displace a continuous annular cavity between liner (para 0209, 0305). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Tozzi with the teachings of Anstadt to modulate both the left and right ventricles to provide the predictable result of providing a continuous annular cavity between liners.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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